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

This study has suspended participant recruitment.
(Study suspended by decision strategically.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01408069
First Posted: August 3, 2011
Last Update Posted: March 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
EMS
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
No Contacts or Locations Provided
  More Information

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01408069     History of Changes
Other Study ID Numbers: ACHEMS0211
First Submitted: August 1, 2011
First Posted: August 3, 2011
Last Update Posted: March 26, 2013
Last Verified: March 2013

Keywords provided by EMS:
headache
migraine

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Caffeine
Ergotamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Oxytocics
Reproductive Control Agents
Vasoconstrictor Agents
Serotonin Receptor Agonists
Serotonin Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents