Trial Outcomes & Findings for A Dose-Finding Study of MK0974 in Acute Migraine (MK0974-004) (NCT NCT00246337)
NCT ID: NCT00246337
Last Updated: 2015-11-02
Results Overview
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
420 participants
Primary outcome timeframe
2 hours post dose
Results posted on
2015-11-02
Participant Flow
20 centers from the United States participated. First Patient treated on 01 December 2005; Last Patient Last Treatment was on 01 May 2006.
Participants were assessed, using the protocol inclusion and exclusion criteria, at Visit 1, and if eligible were randomized at that same visit.
Participant milestones
| Measure |
Placebo
Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
|
MK0974 25 mg
MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 50 mg
MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 100 mg
MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 200 mg
MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 300 mg
MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 400 mg
MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 600 mg
MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
Rizatriptan 10 mg
Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
147
|
16
|
18
|
17
|
16
|
54
|
54
|
53
|
45
|
|
Overall Study
Completed Period (Initial Dose)
|
46
|
4
|
9
|
5
|
8
|
29
|
29
|
27
|
19
|
|
Overall Study
Completed Period (Both Doses)
|
69
|
10
|
6
|
11
|
4
|
10
|
16
|
13
|
15
|
|
Overall Study
COMPLETED
|
115
|
14
|
15
|
16
|
12
|
39
|
45
|
40
|
34
|
|
Overall Study
NOT COMPLETED
|
32
|
2
|
3
|
1
|
4
|
15
|
9
|
13
|
11
|
Reasons for withdrawal
| Measure |
Placebo
Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
|
MK0974 25 mg
MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 50 mg
MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 100 mg
MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 200 mg
MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 300 mg
MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 400 mg
MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 600 mg
MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
Rizatriptan 10 mg
Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
0
|
0
|
2
|
2
|
1
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Lack of Qualifying Event
|
8
|
2
|
1
|
1
|
1
|
3
|
3
|
2
|
5
|
|
Overall Study
Site Terminated
|
10
|
0
|
0
|
0
|
0
|
7
|
1
|
6
|
2
|
|
Overall Study
Abnormal baseline lab values
|
7
|
0
|
2
|
0
|
0
|
2
|
2
|
0
|
4
|
|
Overall Study
Overwhelmed
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violator
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Reported as completing trial in error
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Dose-Finding Study of MK0974 in Acute Migraine (MK0974-004)
Baseline characteristics by cohort
| Measure |
Placebo
n=115 Participants
Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
The reported number of participants are all patients randomized who received study drug and completed the study.
|
MK0974 25 mg
n=14 Participants
MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
The reported number of participants are all patients randomized who received study drug and completed the study.
|
MK0974 50 mg
n=15 Participants
MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
The reported number of participants are all patients randomized who received study drug and completed the study.
|
MK0974 100 mg
n=16 Participants
MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
The reported number of participants are all patients randomized who received study drug and completed the study.
|
MK0974 200 mg
n=12 Participants
MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
The reported number of participants are all patients randomized who received study drug and completed the study.
|
MK0974 300 mg
n=39 Participants
MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
The reported number of participants are all patients randomized who received study drug and completed the study.
|
MK0974 400 mg
n=45 Participants
MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
The reported number of participants are all patients randomized who received study drug and completed the study.
|
MK0974 600 mg
n=40 Participants
MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
The reported number of participants are all patients randomized who received study drug and completed the study.
|
Rizatriptan 10 mg
n=34 Participants
Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
The reported number of participants are all patients randomized who received study drug and completed the study.
|
Total
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
43.0 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
41.5 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
40.9 years
STANDARD_DEVIATION 7.5 • n=4 Participants
|
34.3 years
STANDARD_DEVIATION 11.7 • n=21 Participants
|
40.5 years
STANDARD_DEVIATION 10.4 • n=8 Participants
|
40.1 years
STANDARD_DEVIATION 11.9 • n=8 Participants
|
44.5 years
STANDARD_DEVIATION 12.0 • n=24 Participants
|
40.2 years
STANDARD_DEVIATION 10.8 • n=42 Participants
|
41.5 years
STANDARD_DEVIATION 10.9 • n=42 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
34 Participants
n=8 Participants
|
42 Participants
n=8 Participants
|
36 Participants
n=24 Participants
|
28 Participants
n=42 Participants
|
292 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
38 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
92 participants
n=5 Participants
|
10 participants
n=7 Participants
|
11 participants
n=5 Participants
|
11 participants
n=4 Participants
|
6 participants
n=21 Participants
|
29 participants
n=8 Participants
|
34 participants
n=8 Participants
|
38 participants
n=24 Participants
|
28 participants
n=42 Participants
|
259 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black
|
18 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
5 participants
n=21 Participants
|
7 participants
n=8 Participants
|
10 participants
n=8 Participants
|
2 participants
n=24 Participants
|
5 participants
n=42 Participants
|
57 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
2 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
European
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
1 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Hispanic American
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
3 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
9 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
|
Baseline Severity
Moderate
|
81 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
30 Participants
n=24 Participants
|
27 Participants
n=42 Participants
|
239 Participants
n=42 Participants
|
|
Baseline Severity
Severe
|
34 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
90 Participants
n=42 Participants
|
|
Baseline Severity
Baseline Severity data missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 2 hours post dosePopulation: All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized. One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing.
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack.
Outcome measures
| Measure |
Placebo
n=115 Participants
Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
|
MK0974 25 mg
n=14 Participants
MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 50 mg
n=15 Participants
MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 100 mg
n=16 Participants
MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 200 mg
n=12 Participants
MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 300 mg
n=38 Participants
MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 400 mg
n=45 Participants
MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 600 mg
n=40 Participants
MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
Rizatriptan 10 mg
n=34 Participants
Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pain Relief at 2 Hours
|
52 Participants
|
5 Participants
|
9 Participants
|
8 Participants
|
5 Participants
|
25 Participants
|
22 Participants
|
27 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 2 hours post dosePopulation: All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized. One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing.
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain freedom is defined as no pain (Grade 0) at 2 hours post dose.
Outcome measures
| Measure |
Placebo
n=115 Participants
Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
|
MK0974 25 mg
n=14 Participants
MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 50 mg
n=15 Participants
MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 100 mg
n=16 Participants
MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 200 mg
n=12 Participants
MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 300 mg
n=38 Participants
MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 400 mg
n=45 Participants
MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 600 mg
n=40 Participants
MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
Rizatriptan 10 mg
n=34 Participants
Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pain Freedom at 2 Hours
|
16 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
17 Participants
|
11 Participants
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 2-24 hours post dosePopulation: All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized. One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain relief is defined as pain relief at 2 hours and no headache recurrence, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.
Outcome measures
| Measure |
Placebo
n=115 Participants
Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
|
MK0974 25 mg
n=13 Participants
MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 50 mg
n=15 Participants
MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 100 mg
n=16 Participants
MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 200 mg
n=11 Participants
MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 300 mg
n=38 Participants
MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 400 mg
n=45 Participants
MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 600 mg
n=40 Participants
MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
Rizatriptan 10 mg
n=34 Participants
Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
|---|---|---|---|---|---|---|---|---|---|
|
Sustained Pain Relief
|
27 Participants
|
1 Participants
|
9 Participants
|
3 Participants
|
3 Participants
|
20 Participants
|
17 Participants
|
21 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 2-24 hours post dosePopulation: All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized. One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing.
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain freedom is defined as pain freedom at 2 hours and no headache return to mild/moderate/severe, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.
Outcome measures
| Measure |
Placebo
n=115 Participants
Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
|
MK0974 25 mg
n=13 Participants
MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 50 mg
n=15 Participants
MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 100 mg
n=16 Participants
MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 200 mg
n=11 Participants
MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 300 mg
n=38 Participants
MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 400 mg
n=45 Participants
MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 600 mg
n=40 Participants
MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
Rizatriptan 10 mg
n=34 Participants
Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
|---|---|---|---|---|---|---|---|---|---|
|
Sustained Pain Freedom
|
12 Participants
|
1 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
15 Participants
|
10 Participants
|
13 Participants
|
6 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
MK0974 25 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MK0974 50 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
MK0974 100 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MK0974 200 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
MK0974 300 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
MK0974 400 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
MK0974 600 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Rizatriptan 10 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=47 participants at risk
Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
|
MK0974 25 mg
n=17 participants at risk
MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 50 mg
n=19 participants at risk
MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 100 mg
n=27 participants at risk
MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 200 mg
n=18 participants at risk
MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 300 mg
n=51 participants at risk
MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 400 mg
n=52 participants at risk
MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 600 mg
n=49 participants at risk
MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
Rizatriptan 10 mg
n=50 participants at risk
Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
2.1%
1/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
Other adverse events
| Measure |
Placebo
n=47 participants at risk
Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
|
MK0974 25 mg
n=17 participants at risk
MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 50 mg
n=19 participants at risk
MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 100 mg
n=27 participants at risk
MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 200 mg
n=18 participants at risk
MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 300 mg
n=51 participants at risk
MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 400 mg
n=52 participants at risk
MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
MK0974 600 mg
n=49 participants at risk
MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
Rizatriptan 10 mg
n=50 participants at risk
Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.6%
1/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.6%
1/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
|
Eye disorders
Eye pain
|
0.00%
0/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.3%
1/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
2.0%
1/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
|
Gastrointestinal disorders
Dry mouth
|
2.1%
1/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.9%
1/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
3.7%
1/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
3.9%
2/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
3.8%
2/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
2.0%
1/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
2.0%
1/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.3%
1/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
3.7%
1/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
1.9%
1/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
|
Gastrointestinal disorders
Nausea
|
12.8%
6/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
3.7%
1/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.9%
3/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
9.6%
5/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
10.2%
5/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
2.0%
1/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.9%
1/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
3.8%
2/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
2.0%
1/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
|
General disorders
Fatigue
|
0.00%
0/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.9%
1/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
15.8%
3/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
7.4%
2/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
1.9%
1/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
2.0%
1/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
4.0%
2/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.6%
1/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
1.9%
1/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
|
Investigations
Platelet count increased
|
0.00%
0/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.6%
1/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
|
Metabolism and nutrition disorders
Food craving
|
0.00%
0/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.6%
1/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.6%
1/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
|
Nervous system disorders
Dizziness
|
4.3%
2/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
10.5%
2/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
11.1%
2/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.9%
3/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
1.9%
1/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
8.2%
4/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
2.0%
1/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
|
Nervous system disorders
Dysgeusia
|
2.1%
1/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.6%
1/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
2.0%
1/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
2.0%
1/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.3%
1/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
2.0%
1/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.3%
1/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
2.0%
1/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
4.0%
2/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.3%
1/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
3.7%
1/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
11.1%
2/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
3.9%
2/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
1.9%
1/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
8.2%
4/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
4.0%
2/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.3%
1/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.6%
1/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/47 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
5.9%
1/17 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/19 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
3.7%
1/27 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/18 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/51 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/52 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/49 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
0.00%
0/50 • Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized.
For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group.
|
Additional Information
Vice President of Late Stage Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER