Status:
UNKNOWN
Study Assessing the Efficacy of Etoricoxib in Female Patients With Fibromyalgia
Lead Sponsor:
Meir Medical Center
Conditions:
Fibromyalgia
Eligibility:
FEMALE
18-75 years
Phase:
PHASE4
Brief 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 psychiatr...
Detailed Description
The fibromyalgia syndrome (FMS) is an ill-defined clinical disorder characterized by widespread pain and diffuse tenderness which is assessed at specified anatomical locations. The FMS is 10 times mor...
Eligibility Criteria
Inclusion
- • 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
- • 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00755521
Start Date
September 1 2008
End Date
December 1 2012
Last Update
August 10 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Medicine 'D', Meir Medical Center
Kfar Saba, Israel, 44281