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

Information source: EMS
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tensional-type Headache

Intervention: MIGRANE (Drug); PARCEL (Drug)

Phase: Phase 3

Status: Suspended

Sponsored by: EMS

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.

Clinical Details

Official title: Multicentric, Randomizade, Double Blind, Double Dummy To Non-Inferiority Comparison Of Migrane® Versus Parcel ® For Treatment Of Tensional Cephaleia

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Efficacy of treatment in relieve headache symptoms.

Secondary outcome: Tolerability of study treatment

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: March 2014
Last updated: March 25, 2013

Page last updated: August 23, 2015

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