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

Overview

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.

Full Title of Study: “Multicentric, Randomizade, Double Blind, Double Dummy To Non-Inferiority Comparison Of Migrane® Versus Parcel ® For Treatment Of Tensional Cephaleia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: October 2014

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.

Interventions

  • Drug: MIGRANE
    • 1 to 2 tablets(ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg)
  • Drug: PARCEL
    • 1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)

Arms, Groups and Cohorts

  • Experimental: MIGRANE
    • 1 to 2 tablets ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg
  • Active Comparator: PARCEL
    • 1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Tolerability of study treatment
    • Time Frame: 56 days
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • EMS
  • Provider of Information About this Clinical Study
    • Sponsor

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