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

EMS

Status and phase: Withdrawn; Phase 3

Conditions: Tensional-type Headache

Treatments: Drug: MIGRANE; Drug: PARCEL

Study type: Interventional

Funder types: Industry

Identifiers

NCT01408069

ACHEMS0211

Details and patient eligibility

About

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 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

0 participants in 2 patient groups

MIGRANE

Experimental group

Description:

1 to 2 tablets ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg

Treatment:

Drug: MIGRANE

PARCEL

Active Comparator group

Description:

1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)

Treatment:

Drug: PARCEL