Ibuprofen Versus Ibuprofen Plus Caffeine in the Treatment of Migraine.
- Registration Number
- NCT01426971
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
- To compare the treatment groups in the reduction of pain score by at least 30 mm on a visual pain scale (VAS) at 60 minutes after study medication intake, compared to the baseline score (obtained before the study medication intake).
Secondary Objectives:
* To assess the proportion of patients with more than 50% pain relief, according to the VAS score at 45 minutes after study medication intake compared to baseline
* Determine the following aspects in the timing of study medication intake:
* Time to the first perception of pain relief
* Time to onset of meaningful pain relief
* Reduction of pain at 15, 30, 45, 60, 120 and 240 minutes after study medication intake, to be evaluated as the difference between the scores on VAS in each period and baseline
* To assess the pain according to the five items of Headache Relief Rating - HRR (0: strong worsening 1: slight worsening 2: no change 3: slight improvement 4: strong improvement) at 15, 30, 45 and 60 minutes after study medication intake, according to the diaries completed by the patients
* To check the proportion of the patients requiring the third tablet of study medication within 24 hours of starting the study treatment and when it occurred
* To check the timing and frequency of rescue medication intake, as well as the proportion of patients who used these medications within 24 hours of starting the treatment
* Safety assessment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ibuprofen+caffeine IBUPROFEN + CAFFEINE 2 capsules Ibuprofen IBUPROFEN 2 capsules
- Primary Outcome Measures
Name Time Method Number of patients with reduction of at least 30mm in the visual scale (VAS) of pain from baseline to 60 minutes
- Secondary Outcome Measures
Name Time Method Number of patients with more than 50% of pain reduction up to 45 minutes Median time of the first perception of pain relief since study medication intake 4 hours Median time to onset of significant pain relief compared to the time of study medication intake 4 hours Headache Relief Rating score (HRR) up to 60 mins Mean of VAS difference between each time after medication intake and the baseline. 15, 30, 45, 60, 120 and 240 minutes post dose Number of patients who used the third tablet of study medication up to 24 hours Number of patients requiring rescue medication up to 24 hours