Study Assessing the Efficacy of Etoricoxib in Female Patients With Fibromyalgia
Study Proposal - A Randomized Double-blinded Study Comparing Adding Etoricoxib Versus Placebo to Female Patients With Fibromyalgia-analysis of Organic and Psychiatric Measures
1 other identifier
interventional
80
1 country
1
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 psychiatric and rheumatologic parameters of the disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2008
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 18, 2008
CompletedFirst Posted
Study publicly available on registry
September 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedAugust 10, 2012
August 1, 2012
2.1 years
September 18, 2008
August 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brief pain inventory
6 weeks
Secondary Outcomes (1)
Tender point count, SF-36, Mini International Neuropsychiatric Interview
2 years
Study Arms (2)
B
NO INTERVENTIONA
EXPERIMENTALadding Etoricoxib to the basic therapeutic regimen
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medicine 'D', Meir Medical Center
Kfar Saba, 44281, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Howard Amital, MD MHA
Meir Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2008
First Posted
September 19, 2008
Study Start
September 1, 2008
Primary Completion
October 1, 2010
Study Completion
December 1, 2012
Last Updated
August 10, 2012
Record last verified: 2012-08