Trial Outcomes & Findings for Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain (NCT NCT04571515)
NCT ID: NCT04571515
Last Updated: 2022-08-08
Results Overview
Participants assessed Pain Intensity (PI) using a 0-10 numeric pain rating scale (NPRS) where 0 is no pain and 10 is worst pain imaginable. PI was assessed 17 times within 24 hours after the first study dose, and immediately before any rescue medication and/or at early termination. The participant's baseline PI was subtracted from the timepoint PI, to derive a Pain Intensity Difference (PID) for each timepoint. Overall Summed Pain Intensity Difference (SPID) measures pain intensity change relative to baseline over the 24 hour period after dosing, and corresponds to the Area Under the Curve (AUC) of the PID. In this study, higher positive Overall SPID indicates better pain improvement. Overall SPID could range from -120 to 240. Two hour windowed last observation carried forward was used as applicable where PI score obtained before a rescue medication replaced PI score for each timepoint within 2 hours following rescue dose.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
114 participants
Primary outcome timeframe
24 hours after the first dose
Results posted on
2022-08-08
Participant Flow
Participant milestones
| Measure |
MR-107A-01 10 mg Once in a 24-hour Period
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Once in a 24-hour Period
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 10 mg Twice in a 24-hour Period
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Twice in a 24-hour Period
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
Placebo Twice in a 24-hour Period
Placebo tablet one day of dosing
Placebo: Oral tablet
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
24
|
23
|
23
|
22
|
|
Overall Study
COMPLETED
|
21
|
24
|
23
|
23
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
MR-107A-01 10 mg Once in a 24-hour Period
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Once in a 24-hour Period
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 10 mg Twice in a 24-hour Period
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Twice in a 24-hour Period
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
Placebo Twice in a 24-hour Period
Placebo tablet one day of dosing
Placebo: Oral tablet
|
|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
insufficient pain
|
1
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
Baseline characteristics by cohort
| Measure |
MR-107A-01 10 mg Once in a 24-hour Period
n=21 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Once in a 24-hour Period
n=24 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 10 mg Twice in a 24-hour Period
n=23 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Twice in a 24-hour Period
n=23 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
Placebo Twice in a 24-hour Period
n=21 Participants
Placebo tablet one day of dosing
Placebo: Oral tablet
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
20.1 years
STANDARD_DEVIATION 2.17 • n=5 Participants
|
19.2 years
STANDARD_DEVIATION 1.46 • n=7 Participants
|
19.8 years
STANDARD_DEVIATION 2.37 • n=5 Participants
|
19.4 years
STANDARD_DEVIATION 2.39 • n=4 Participants
|
20.1 years
STANDARD_DEVIATION 2.41 • n=21 Participants
|
19.7 years
STANDARD_DEVIATION 2.17 • n=8 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
60 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
52 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
89 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
104 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 24 hours after the first dosePopulation: Modified Intent to Treat Analysis Set
Participants assessed Pain Intensity (PI) using a 0-10 numeric pain rating scale (NPRS) where 0 is no pain and 10 is worst pain imaginable. PI was assessed 17 times within 24 hours after the first study dose, and immediately before any rescue medication and/or at early termination. The participant's baseline PI was subtracted from the timepoint PI, to derive a Pain Intensity Difference (PID) for each timepoint. Overall Summed Pain Intensity Difference (SPID) measures pain intensity change relative to baseline over the 24 hour period after dosing, and corresponds to the Area Under the Curve (AUC) of the PID. In this study, higher positive Overall SPID indicates better pain improvement. Overall SPID could range from -120 to 240. Two hour windowed last observation carried forward was used as applicable where PI score obtained before a rescue medication replaced PI score for each timepoint within 2 hours following rescue dose.
Outcome measures
| Measure |
MR-107A-01 10 mg Once in a 24-hour Period
n=21 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Once in a 24-hour Period
n=24 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 10 mg Twice in a 24-hour Period
n=23 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Twice in a 24-hour Period
n=23 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
Placebo Twice in a 24-hour Period
n=21 Participants
Placebo tablet one day of dosing
Placebo: Oral tablet
|
|---|---|---|---|---|---|
|
Overall Summed Pain Intensity Difference (SPID)
|
109.5 score on a scale * hours
Standard Deviation 32.82
|
111.8 score on a scale * hours
Standard Deviation 40.37
|
108.8 score on a scale * hours
Standard Deviation 33.85
|
108.6 score on a scale * hours
Standard Deviation 40.20
|
80.0 score on a scale * hours
Standard Deviation 39.78
|
SECONDARY outcome
Timeframe: 24 hours after the first dosePopulation: Modified Intent to Treat
10 point scale, where 0 is no pain and 10 is the worst pain imaginable; 2-hour windowed last observation carried forward (W2LOCF) utilizes "pain right now" just prior to rescue medication use and censors subsequent pain intensity values for 2 hours when calculating SPIDs
Outcome measures
| Measure |
MR-107A-01 10 mg Once in a 24-hour Period
n=21 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Once in a 24-hour Period
n=24 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 10 mg Twice in a 24-hour Period
n=23 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Twice in a 24-hour Period
n=22 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
Placebo Twice in a 24-hour Period
n=21 Participants
Placebo tablet one day of dosing
Placebo: Oral tablet
|
|---|---|---|---|---|---|
|
Pain Intensity Using a Numeric Pain Rating Scale Utilizing 2-hour Windowed Last Observation Carried Forward (W2LOCF)
|
2.5 score on a scale
Standard Deviation 1.86
|
2.1 score on a scale
Standard Deviation 1.60
|
1.5 score on a scale
Standard Deviation 1.34
|
2.3 score on a scale
Standard Deviation 1.98
|
2.5 score on a scale
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: 24 hours after the first dosePopulation: Modified Intent to Treat Analysis Set
Pain relief was assessed by participants using a 5 point scale, where 0 = none, 1 = slight, 2 = moderate, 3 = good or a lot, and 4 = complete. Pain relief was measured 17 times within 24 hours after the first study medication dose, and immediately before any rescue medication and/or at the time of early termination. Two-hour windowed last observation carried forward approach was used whereby the pain relief score obtained before a given rescue medication was carried forward to replace the pain relief scores collected at each observation timepoint within 2 hours following the rescue dose. Total pain relief (TOTPAR) had Areas Under the Curve (AUCs) calculated for each time point. The range for 24 hours post dose TOTPAR AUC was 0 to 96. Higher positive values indicate a better outcome with larger pain improvements.
Outcome measures
| Measure |
MR-107A-01 10 mg Once in a 24-hour Period
n=21 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Once in a 24-hour Period
n=24 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 10 mg Twice in a 24-hour Period
n=23 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Twice in a 24-hour Period
n=23 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
Placebo Twice in a 24-hour Period
n=21 Participants
Placebo tablet one day of dosing
Placebo: Oral tablet
|
|---|---|---|---|---|---|
|
Total Pain Relief
|
55.5 score on a scale * hours
Standard Deviation 12.31
|
57.3 score on a scale * hours
Standard Deviation 11.29
|
60.2 score on a scale * hours
Standard Deviation 13.48
|
56.6 score on a scale * hours
Standard Deviation 16.82
|
41.2 score on a scale * hours
Standard Deviation 17.05
|
SECONDARY outcome
Timeframe: 24 hours after the first dosePopulation: Modified Intent to Treat Analysis Set
The time to onset of first perceptible relief was defined as the post dose time at which the subject first begins to feel pain relief. The time to meaningful pain relief was defined as the post dose time at which the subject begins to feel meaningful pain relief. The assessments of perceptible and meaningful pain relief were ceased when rescue medication was taken.
Outcome measures
| Measure |
MR-107A-01 10 mg Once in a 24-hour Period
n=21 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Once in a 24-hour Period
n=24 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 10 mg Twice in a 24-hour Period
n=23 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Twice in a 24-hour Period
n=23 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
Placebo Twice in a 24-hour Period
n=21 Participants
Placebo tablet one day of dosing
Placebo: Oral tablet
|
|---|---|---|---|---|---|
|
Pain Relief: Number and Percentage of Subjects With Perceptible and Meaningful Pain Relief
Perceptible Pain Relief
|
15 Participants
|
22 Participants
|
16 Participants
|
19 Participants
|
10 Participants
|
|
Pain Relief: Number and Percentage of Subjects With Perceptible and Meaningful Pain Relief
Meaningful Pain Relief
|
10 Participants
|
17 Participants
|
13 Participants
|
15 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 24 hours after the first dosePopulation: Modified Intent to Treat Analysis Set
5 point scale, where 0 is poor, 1 is fair, 2 is good, 3 is very good, and 4 is excellent Responder = 2 is good, 3 is very good, and 4 is excellent, Non-responder = 1 is fair, 0 is poor, and missing values
Outcome measures
| Measure |
MR-107A-01 10 mg Once in a 24-hour Period
n=21 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Once in a 24-hour Period
n=24 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 10 mg Twice in a 24-hour Period
n=23 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Twice in a 24-hour Period
n=23 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
Placebo Twice in a 24-hour Period
n=21 Participants
Placebo tablet one day of dosing
Placebo: Oral tablet
|
|---|---|---|---|---|---|
|
Patient's Global Assessment of Pain Control
Responders
|
14 Participants
|
16 Participants
|
18 Participants
|
13 Participants
|
7 Participants
|
|
Patient's Global Assessment of Pain Control
Non-responders
|
7 Participants
|
8 Participants
|
5 Participants
|
10 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 24 hours after the first dosePopulation: Modified Intent to Treat
Number of rescue medication doses
Outcome measures
| Measure |
MR-107A-01 10 mg Once in a 24-hour Period
n=21 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Once in a 24-hour Period
n=24 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 10 mg Twice in a 24-hour Period
n=23 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Twice in a 24-hour Period
n=23 Participants
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
Placebo Twice in a 24-hour Period
n=21 Participants
Placebo tablet one day of dosing
Placebo: Oral tablet
|
|---|---|---|---|---|---|
|
Rescue Medication Use
|
0.8 Medication doses
Standard Deviation 1.03
|
0.8 Medication doses
Standard Deviation 0.92
|
0.7 Medication doses
Standard Deviation 0.70
|
0.7 Medication doses
Standard Deviation 1.14
|
1.8 Medication doses
Standard Deviation 1.58
|
Adverse Events
MR-107A-01 10 mg Once in a 24-hour Period
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MR-107A-01 15 mg Once in a 24-hour Period
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
MR-107A-01 10 mg Twice in a 24-hour Period
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
MR-107A-01 15 mg Twice in a 24-hour Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Twice in a 24-hour Period
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MR-107A-01 10 mg Once in a 24-hour Period
n=21 participants at risk
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Once in a 24-hour Period
n=24 participants at risk
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 10 mg Twice in a 24-hour Period
n=23 participants at risk
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
MR-107A-01 15 mg Twice in a 24-hour Period
n=23 participants at risk
Oral tablet one day of dosing
MR-107A-01: Oral tablet
|
Placebo Twice in a 24-hour Period
n=21 participants at risk
Placebo tablet one day of dosing
Placebo: Oral tablet
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication.
An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
|
12.5%
3/24 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication.
An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
|
13.0%
3/23 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication.
An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
|
0.00%
0/23 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication.
An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
|
4.8%
1/21 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication.
An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
|
|
Nervous system disorders
Headache
|
14.3%
3/21 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication.
An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
|
12.5%
3/24 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication.
An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
|
4.3%
1/23 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication.
An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
|
0.00%
0/23 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication.
An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
|
4.8%
1/21 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication.
An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication.
An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
|
0.00%
0/24 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication.
An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
|
8.7%
2/23 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication.
An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
|
0.00%
0/23 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication.
An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
|
0.00%
0/21 • Study period reporting of Adverse Events was up to 7 days post first dose. Subjects were reminded that AEs should be reported to the study staff up to 30 days after the last dose of study medication.
An adverse event is any untoward medical occurrence in a patient/ clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory/ physical findings, symptom, or disease (new/ exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
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Additional Information
Susanne Vogt
MEDA Pharma GmbH & Co. KG (A Viatris Company)
Phone: +49 (0) 172 19 20 321
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60