Pain Clinical Trial
Official title:
National, Controlled, Randomized, Double-blind, Parallel Study to Investigate the Efficacy of 2 Capsules of Ibuprofen 400mg in Association With Caffeine 100mg in Fixed Dose Combination Compared to Two Capsules of Ibuprofen 400mg in the Treatment of Migraine
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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