Trials / Withdrawn
WithdrawnNCT01408069
Non-Inferiority Comparison of Migrane® Versus Parcel ® For Treatment of Tensional Cephaleia
Multicentric, Randomizade, Double Blind, Double Dummy To Non-Inferiority Comparison Of Migrane® Versus Parcel ® For Treatment Of Tensional Cephaleia
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- EMS · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- First posted
- 2011-08-03
- Last updated
- 2021-02-24
Source: ClinicalTrials.gov record NCT01408069. Inclusion in this directory is not an endorsement.