Trial Outcomes & Findings for Pilot Study to Collect and Evaluate Data on the Use of IV* Ibuprofen in the Treatment of an Acute Migraine Attack (NCT NCT01230411)
NCT ID: NCT01230411
Last Updated: 2022-09-06
Results Overview
Comparison of proportion of subjects in each treatment group (active treatment and placebo) who have pain relief at 2 hours after the completion of the double-blind treatment infusion. Pain relief is defined as a reduction in headache pain level from severe or moderate decreased to mild or headache-free, respectively.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
44 participants
Primary outcome timeframe
2 hours
Results posted on
2022-09-06
Participant Flow
Participant milestones
| Measure |
Placebo
IV saline administration as placebo
saline placebo: 250 cc of placebo administered IV
|
Ibuprofen
IV ibuprofen
Ibuprofen: 800 mg ibuprofen in 250 cc saline administered IV
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
23
|
|
Overall Study
COMPLETED
|
21
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=21 Participants
IV saline administration as placebo
saline placebo: 250 cc of placebo administered IV
|
Ibuprofen
n=23 Participants
IV ibuprofen
Ibuprofen: 800 mg ibuprofen in 250 cc saline administered IV
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.3 years
STANDARD_DEVIATION 12.1 • n=21 Participants
|
42.8 years
STANDARD_DEVIATION 10.5 • n=23 Participants
|
41.0 years
STANDARD_DEVIATION 11.2 • n=44 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=21 Participants
|
16 Participants
n=23 Participants
|
33 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=21 Participants
|
7 Participants
n=23 Participants
|
11 Participants
n=44 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Migraine Duration Since onset (years)
|
16.4 years
STANDARD_DEVIATION 10.4 • n=21 Participants
|
23.6 years
STANDARD_DEVIATION 11.4 • n=23 Participants
|
20 years
STANDARD_DEVIATION 10.9 • n=44 Participants
|
PRIMARY outcome
Timeframe: 2 hoursComparison of proportion of subjects in each treatment group (active treatment and placebo) who have pain relief at 2 hours after the completion of the double-blind treatment infusion. Pain relief is defined as a reduction in headache pain level from severe or moderate decreased to mild or headache-free, respectively.
Outcome measures
| Measure |
Placebo
n=21 Participants
IV saline administration as placebo
saline placebo: 250 cc of placebo administered IV
|
Ibuprofen
n=23 Participants
IV ibuprofen
Ibuprofen: 800 mg ibuprofen in 250 cc saline administered IV
|
|---|---|---|
|
Comparison of Proportion of Subjects in Control and Active Treatment Groups Who Have Pain Relief at 2 Hours After the Completion of the Double-blind Treatment Infusion.
|
10 Participants
|
17 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ibuprofen
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=21 participants at risk
IV saline administration as placebo
saline placebo: 250 cc of placebo administered IV
|
Ibuprofen
n=23 participants at risk
IV ibuprofen
Ibuprofen: 800 mg ibuprofen in 250 cc saline administered IV
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
arm pain
|
4.8%
1/21 • Adverse events were collected from the start of treatment ( which could take up to 1 hr), then at post treatment time points: 30 min , 1hour, 2 hour as well as during the 24 hr post treatment phone call and at 1 week follow up.
|
8.7%
2/23 • Adverse events were collected from the start of treatment ( which could take up to 1 hr), then at post treatment time points: 30 min , 1hour, 2 hour as well as during the 24 hr post treatment phone call and at 1 week follow up.
|
|
Gastrointestinal disorders
Gastrointestinal disturbance
|
9.5%
2/21 • Adverse events were collected from the start of treatment ( which could take up to 1 hr), then at post treatment time points: 30 min , 1hour, 2 hour as well as during the 24 hr post treatment phone call and at 1 week follow up.
|
0.00%
0/23 • Adverse events were collected from the start of treatment ( which could take up to 1 hr), then at post treatment time points: 30 min , 1hour, 2 hour as well as during the 24 hr post treatment phone call and at 1 week follow up.
|
|
Nervous system disorders
dizziness
|
0.00%
0/21 • Adverse events were collected from the start of treatment ( which could take up to 1 hr), then at post treatment time points: 30 min , 1hour, 2 hour as well as during the 24 hr post treatment phone call and at 1 week follow up.
|
4.3%
1/23 • Adverse events were collected from the start of treatment ( which could take up to 1 hr), then at post treatment time points: 30 min , 1hour, 2 hour as well as during the 24 hr post treatment phone call and at 1 week follow up.
|
|
Nervous system disorders
Cold sensitivity
|
0.00%
0/21 • Adverse events were collected from the start of treatment ( which could take up to 1 hr), then at post treatment time points: 30 min , 1hour, 2 hour as well as during the 24 hr post treatment phone call and at 1 week follow up.
|
4.3%
1/23 • Adverse events were collected from the start of treatment ( which could take up to 1 hr), then at post treatment time points: 30 min , 1hour, 2 hour as well as during the 24 hr post treatment phone call and at 1 week follow up.
|
|
Nervous system disorders
Neck pain
|
0.00%
0/21 • Adverse events were collected from the start of treatment ( which could take up to 1 hr), then at post treatment time points: 30 min , 1hour, 2 hour as well as during the 24 hr post treatment phone call and at 1 week follow up.
|
4.3%
1/23 • Adverse events were collected from the start of treatment ( which could take up to 1 hr), then at post treatment time points: 30 min , 1hour, 2 hour as well as during the 24 hr post treatment phone call and at 1 week follow up.
|
Additional Information
Dr. Hsiangkuo Yuan
Thomas Jefferson University- Jefferson Headache Center
Phone: 2159552243
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place