Study Assessing the Efficacy of Etoricoxib in Female Patients With Fibromyalgia - Full Text View

Sponsored by:	Meir Medical Center
Information provided by:	Meir Medical Center
ClinicalTrials.gov Identifier:	NCT00755521

Purpose

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.

Condition	Intervention	Phase
Fibromyalgia	Drug: etoricoxib	Phase IV

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Etoricoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Study Proposal - A Randomized Double-Blinded Study Comparing Adding Etoricoxib Versus Placebo to Female Patients With Fibromyalgia-Analysis of Organic and Psychiatric Measures

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:

Brief pain inventory [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tender point count, SF-36, Mini International Neuropsychiatric Interview [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	September 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: No Intervention
A: Experimental adding Etoricoxib to the basic therapeutic regimen	Drug: etoricoxib Treating Fibromyalgia with etoricoxib etoricoxib - 90mg

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Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755521

Contacts

Contact: Howard Amital, MD MHA

972-9-7472598

hamital@netvision.net.il

Locations

Israel
Howard Amital
Kfar Saba, Israel, 44281

Sponsors and Collaborators

Meir Medical Center

Investigators

Principal Investigator:

Howard Amital, MD MHA

Meir Medical Center

More Information

Responsible Party:	internal dep d ( Howard Amital MD MHA, internal dep d )
Study ID Numbers:	0134-08-MMC
Study First Received:	September 18, 2008
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00755521
Health Authority:	Israel: Ministry of Health

Keywords provided by Meir Medical Center:

Fibromyalgia
tenderness
widespread pain
comrbidity

Study placed in the following topic categories:

Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes

Fibromyalgia
Etoricoxib
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 13, 2009