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Ibuprofen Versus Ibuprofen Plus Caffeine in the Treatment of Migraine.

NCT01426971 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2012-11-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

IBUPROFEN + CAFFEINE

Pharmaceutical form: capsule Route of administration: oral

DRUG

IBUPROFEN

Pharmaceutical form: capsule Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-06-30
Completion
2013-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01426971 on ClinicalTrials.gov