Trial Outcomes & Findings for Treximet Early Intervention Adolescent Migraine (NCT NCT01016678)
NCT ID: NCT01016678
Last Updated: 2016-05-04
Results Overview
All data was collected and measured from self-reported patient diaries
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
104 participants
Primary outcome timeframe
3 years
Results posted on
2016-05-04
Participant Flow
The study recruitment period started in March 2010 and the last subject was exited March 2013. The 4 sites who recruited all patients, consisted of 2 private practices and 2 children's hospital based site.
104 patients were randomized and dispensed study drug but only 94 of those patients actually treated at least one migraine, so therefore 94 subjects data was used in the analysis.
Participant milestones
| Measure |
Active, Active, Active, Placebo
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
First three migraines will be treated with Active Treximet and the last 4th migraine will be treated with Placebo
|
Active, Active, Placebo, Active
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
First two migraines will be treated with Active Treximet and then the 3rd migraine will be treated with Placebo and the last 4th migraine will be treated with Treximet
|
Active, Placebo, Active, Active
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
The first migraine will be treated with Active Treximent and the second migraine with Placebo. The final two migraines will be treated with Active Treximet
|
Placebo, Active, Active, Active
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
First migraine will be treated with Placebo and the last three migraines will be treated with Active Treximet
|
Active, Active, Active, Active
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
All migraines (up to four) will be treated with active treximet
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
17
|
19
|
19
|
19
|
|
Overall Study
COMPLETED
|
18
|
14
|
15
|
19
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
4
|
0
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treximet Early Intervention Adolescent Migraine
Baseline characteristics by cohort
| Measure |
Adolescents Age 12-17
n=104 Participants
All subjects were adolescent males and females with diagnosis of Migraine and a frequency of 1-8 migraines per month on average
|
|---|---|
|
Age, Categorical
<=18 years
|
104 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
14.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
104 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: The number of subjects randomized to treatment was 104, which included 94 subjects who treated at least one migraine with study drug and were included in the safety and efficacy data analysis
All data was collected and measured from self-reported patient diaries
Outcome measures
| Measure |
Migraine Attack 1
n=94 Participants
The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Migraine Attack 2
n=90 Participants
The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Migraine Attack 3
n=82 Participants
The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Migraine Attack 4
n=81 Participants
The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Active, Active, Active, Active
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
All migraines (up to four) will be treated with active treximet
|
|---|---|---|---|---|---|
|
Number of Participants With 2-hour Pain Free Active Study Drug
Pain Free at 2 hours post dose for Active Treatmen
|
35 Participants
|
23 Participants
|
21 Participants
|
24 Participants
|
—
|
|
Number of Participants With 2-hour Pain Free Active Study Drug
Pain Free at 2 Hours Post Dose for Placebo
|
2 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
—
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Patients who treated with study drug and were pain free at 2 hours and then continued to be pain free through 24 hours
All data was collected and measured from self-reported patient diaries
Outcome measures
| Measure |
Migraine Attack 1
n=103 Migraines
The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Migraine Attack 2
n=13 Migraines
The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Migraine Attack 3
The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Migraine Attack 4
The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Active, Active, Active, Active
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
All migraines (up to four) will be treated with active treximet
|
|---|---|---|---|---|---|
|
Percentage of Migraine Attacks With Sustained Pain Free Response From 2 to 24 Hours Post-Dose
|
86 percentage of attacks
|
78 percentage of attacks
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: 94 subjects treated at least one migraine attack with active drug or placebo were analyzed while only 74 subjects had the potential to take placebo during one of their 4 migraine attacks
All data was collected and measured from self-reported patient diaries
Outcome measures
| Measure |
Migraine Attack 1
n=277 number of migraine attacks
The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Migraine Attack 2
n=70 number of migraine attacks
The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Migraine Attack 3
The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Migraine Attack 4
The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Active, Active, Active, Active
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
All migraines (up to four) will be treated with active treximet
|
|---|---|---|---|---|---|
|
Percentage of Migraine Attacks With Pain Free Response at 2 Hours Post-Dose Following Early Intervention
|
32 percentage of attacks
|
18 percentage of attacks
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: This analysis data was not collected.
Collected from patient reported paper diaries
Outcome measures
Outcome data not reported
Adverse Events
Active, Active, Active, Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Active, Active, Placebo, Active
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Active, Placebo, Active, Active
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo, Active, Active, Active
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Active, Active, Active, Active
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active, Active, Active, Placebo
n=20 participants at risk
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Active, Active, Placebo, Active
n=17 participants at risk
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Active, Placebo, Active, Active
n=19 participants at risk
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Placebo, Active, Active, Active
n=19 participants at risk
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Active, Active, Active, Active
n=19 participants at risk
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Prolonged Migraine
|
5.0%
1/20 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/17 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
Other adverse events
| Measure |
Active, Active, Active, Placebo
n=20 participants at risk
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Active, Active, Placebo, Active
n=17 participants at risk
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Active, Placebo, Active, Active
n=19 participants at risk
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Placebo, Active, Active, Active
n=19 participants at risk
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
Active, Active, Active, Active
n=19 participants at risk
Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Neck Spasm/Tension
|
0.00%
0/20 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.9%
1/17 • Number of events 2 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
15.8%
3/19 • Number of events 3 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
10.5%
2/19 • Number of events 4 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
|
Nervous system disorders
Drowsiness
|
5.0%
1/20 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
11.8%
2/17 • Number of events 3 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.3%
1/19 • Number of events 3 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
|
Musculoskeletal and connective tissue disorders
Throat tightness
|
0.00%
0/20 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.9%
1/17 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.3%
1/19 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
15.8%
3/19 • Number of events 6 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
|
Musculoskeletal and connective tissue disorders
Stiff Jaw
|
0.00%
0/20 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
11.8%
2/17 • Number of events 3 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.3%
1/19 • Number of events 2 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.9%
1/17 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.3%
1/19 • Number of events 3 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
|
General disorders
Tongue Swelling
|
0.00%
0/20 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.9%
1/17 • Number of events 2 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.3%
1/19 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
|
Nervous system disorders
Numbness
|
0.00%
0/20 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/17 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
10.5%
2/19 • Number of events 3 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.3%
1/19 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
|
General disorders
Burning Sensation Face
|
0.00%
0/20 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.9%
1/17 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.3%
1/19 • Number of events 2 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.9%
1/17 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
10.5%
2/19 • Number of events 4 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.3%
1/19 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
0.00%
0/20 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/17 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.3%
1/19 • Number of events 3 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/17 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.3%
1/19 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.3%
1/19 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
|
Skin and subcutaneous tissue disorders
Poison Ivy Rash
|
0.00%
0/20 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/17 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.3%
1/19 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
|
General disorders
Bad Taste
|
0.00%
0/20 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/17 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.3%
1/19 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
|
Eye disorders
Herpes Simplex Right Eye
|
0.00%
0/20 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/17 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.3%
1/19 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
|
Infections and infestations
Abcess Right Leg
|
0.00%
0/20 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/17 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.3%
1/19 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
|
Infections and infestations
Cough
|
5.0%
1/20 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/17 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.3%
1/19 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
|
Musculoskeletal and connective tissue disorders
Bruised Coccyx
|
0.00%
0/20 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.9%
1/17 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
|
Musculoskeletal and connective tissue disorders
Broken Right Arm
|
0.00%
0/20 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.9%
1/17 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
|
Infections and infestations
Sinus Infection
|
0.00%
0/20 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/17 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.3%
1/19 • Number of events 1 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
|
General disorders
Weird Feeling, Out of Body Sensation
|
0.00%
0/20 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
5.9%
1/17 • Number of events 2 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
0.00%
0/19 • Entire Study 3 years
All adverse events are reported here whether patient had taken active drug or placebo and it is not separated per intervention
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place