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

This study has suspended participant recruitment.
(Study suspended by decision strategically.)
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01408069
First received: August 1, 2011
Last updated: March 25, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Tensional-type Headache
Drug: MIGRANE
Drug: PARCEL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Multicentric, Randomizade, Double Blind, Double Dummy To Non-Inferiority Comparison Of Migrane® Versus Parcel ® For Treatment Of Tensional Cephaleia

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • Efficacy of treatment in relieve headache symptoms. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Tolerability of study treatment [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 108
Study Start Date: March 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MIGRANE
1 to 2 tablets ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg
Drug: 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)
Drug: PARCEL
1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01408069     History of Changes
Other Study ID Numbers: ACHEMS0211
Study First Received: August 1, 2011
Last Updated: March 25, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by EMS:
headache
migraine

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014