Back to resultsNon-Inferiority Comparison of Migrane® Versus Parcel ® For Treatment of Tensional Cephaleia
Primary Purpose
Tensional-type Headache
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MIGRANE
PARCEL
Sponsored by
About this trial
This is an interventional treatment trial for Tensional-type Headache focused on measuring headache, migraine
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MIGRANE
PARCEL
Arm Description
1 to 2 tablets ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg
1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01408069
Brief Title
Non-Inferiority Comparison of Migrane® Versus Parcel ® For Treatment of Tensional Cephaleia
Official Title
Multicentric, Randomizade, Double Blind, Double Dummy To Non-Inferiority Comparison Of Migrane® Versus Parcel ® For Treatment Of Tensional Cephaleia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study canceled by decision strategically.
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tensional-type Headache
Keywords
headache, migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MIGRANE
Arm Type
Experimental
Arm Description
1 to 2 tablets ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg
Arm Title
PARCEL
Arm Type
Active Comparator
Arm Description
1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)
Intervention Type
Drug
Intervention Name(s)
MIGRANE
Intervention Description
1 to 2 tablets(ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg)
Intervention Type
Drug
Intervention Name(s)
PARCEL
Intervention Description
1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)
Primary Outcome Measure Information:
Title
Efficacy of treatment in relieve headache symptoms.
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Tolerability of study treatment
Description
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.
Time Frame
56 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Non-Inferiority Comparison of Migrane® Versus Parcel ® For Treatment of Tensional Cephaleia
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