Non-Inferiority Comparison of Migrane® Versus Parcel ® For Treatment of Tensional Cephaleia

Study 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.

Official Title
-----------------
Multicentric, Randomizade, Double Blind, Double Dummy To Non-Inferiority Comparison Of Migrane® Versus Parcel ® For Treatment Of Tensional Cephaleia

Conditions
-----------------
Tensional-type Headache

Intervention / Treatment
-----------------
* Drug: MIGRANE
* Drug: PARCEL


Participation Criteria
=================
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. Lactation Use of acetylsalicylic acid or corticosteroids or immunosuppressive therapy. Use of immunosuppressive drugs. Alterations of laboratory selective tests. Drugs or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIGRANE<br>1 to 2 tablets ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg | Drug: MIGRANE<br>* 1 to 2 tablets(ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg)<br>|
| Active Comparator: PARCEL<br>1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg) | Drug: PARCEL<br>* 1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment in relieve headache symptoms. | 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. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of study treatment | Tolerability will be assessed by the investigator through the number of adverse events definitely related to study medication. This relationship will be defined by applying the Naranjo algorithm. | 56 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
headache, migraine