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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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* 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.

Conditions

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Tensional-type Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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MIGRANE

1 to 2 tablets ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg

Group Type EXPERIMENTAL

MIGRANE

Intervention Type DRUG

1 to 2 tablets(ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg)

PARCEL

1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)

Group Type ACTIVE_COMPARATOR

PARCEL

Intervention Type DRUG

1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)

Interventions

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MIGRANE

1 to 2 tablets(ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg)

Intervention Type DRUG

PARCEL

1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients must be able to understand the study procedures agree to participate and give written consent.
2. Tensional-type headache patients according to the International Headache Society criteria.
3. Corporal body indices \< 40.

Exclusion Criteria

1. Pregnancy or risk of pregnancy.
2. Lactation
3. Use of acetylsalicylic acid or corticosteroids or immunosuppressive therapy.
4. Use of immunosuppressive drugs.
5. Alterations of laboratory selective tests.
6. Drugs or alcohol abuse

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No