Multicentric, Randomizade, Double Blind, Double Dummy To Non-Inferiority Comparison Of Migrane® Versus Parcel ® For Treatment Of Tensional Cephaleia
Overview
- Phase
- Phase 3
- Intervention
- MIGRANE
- Conditions
- Tensional-type Headache
- Sponsor
- EMS
- Primary Endpoint
- Efficacy of treatment in relieve headache symptoms.
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different associations of drugs in the treatment of patients diagnosed with tensional-type headache in accordance with International Headache Society guidelines.
Detailed Description
* Open-label, non-inferiority, prospective, parallel group, intent to treat trial. * Experiment duration: 56 days. * 04 visits (days -7, 0, 28 and 56). * Efficacy will be evaluated for 10 episodes of tension-type headache. * Adverse events evaluation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must be able to understand the study procedures agree to participate and give written consent.
- •Tensional-type headache patients according to the International Headache Society criteria.
- •Corporal body indices \< 40.
Exclusion Criteria
- •Pregnancy or risk of pregnancy.
- •Use of acetylsalicylic acid or corticosteroids or immunosuppressive therapy.
- •Use of immunosuppressive drugs.
- •Alterations of laboratory selective tests.
- •Drugs or alcohol abuse
Arms & Interventions
MIGRANE
1 to 2 tablets ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg
Intervention: MIGRANE
PARCEL
1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)
Intervention: PARCEL
Outcomes
Primary Outcomes
Efficacy of treatment in relieve headache symptoms.
Time Frame: 1 hour
The evaluation of efficacy will be determined based on comparison of the intensity of headache before and after 30, 60 and 90 minutes of initiation of treatment.
Secondary Outcomes
- Tolerability of study treatment(56 days)