Study Assessing the Efficacy of Etoricoxib in Female Patients With Fibromyalgia

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The main of the proposed study is to assess whether the use of the Cox-2 inhibitor Etoricoxib is beneficial for the use in fibromyalgia. We intend to seek whether this medication may improve psychiatric and rheumatologic parameters of the disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Meir Medical Center
• Treatments: Etoricoxib

Criteria

Inclusion Criteria:

• • Women with established primary FMS who signed an informed consent form

• Women 18-75 years old.

• The score on the average pain severity item of the BPI is > 5 at randomization.

• Patients on stable physical therapy or anelgestic pain treatment throughout the duration of the study.

Exclusion Criteria:

• • Confirmed pregnancy

• Breast feeding patients

• Patients with active coronary artery disease with documented myocardial ischemia proven by coronary angiography, thallium scan or exercise stress test.

• Patients with congestive heart failure

• Patients with coexistent neoplastic conditions (not including basal cell carcinoma)

• Patients with coexistent t rheumatic/inflammatory conditions

• Patients with active gastrointestinal bleeding

• Patients with renal failure

• Patients with comorbid conditions causing significant disability

• Patients with uncontrolled hypertension.

• Patient with contraindications for the trial drug based on the drug's physician leaflet.