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

Tensional-type Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01408069
• Other study ID #: ACHEMS0211
• Status: Withdrawn
• Phase: Phase 3

Study information

• Verified date: February 2021
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Tensional-type Headache

Intervention

Drug:
• MIGRANE
1 to 2 tablets(ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg)
• PARCEL
1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 hour
Secondary	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.	56 days