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Study Assessing the Efficacy of Etoricoxib in Female Patients With Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00755521
Recruitment Status : Unknown
Verified August 2012 by Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : September 19, 2008
Last Update Posted : August 10, 2012
Information provided by (Responsible Party):
Meir Medical Center

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: etoricoxib Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : September 2008
Actual Primary Completion Date : October 2010
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
No Intervention: B
Experimental: A
adding Etoricoxib to the basic therapeutic regimen
Drug: etoricoxib

Treating Fibromyalgia with etoricoxib

etoricoxib - 90mg

Other Name: Arcoxia

Primary Outcome Measures :
  1. Brief pain inventory [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Tender point count, SF-36, Mini International Neuropsychiatric Interview [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00755521

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Contact: Howard Amital, MD MHA 972-9-7472598

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Department of Medicine 'D', Meir Medical Center Recruiting
Kfar-Saba, Israel, 44281
Contact: Howard Amital, MD MHA    972-9-7472598   
Sponsors and Collaborators
Meir Medical Center
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Principal Investigator: Howard Amital, MD MHA Meir Medical Center
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Responsible Party: Meir Medical Center Identifier: NCT00755521    
Other Study ID Numbers: 0134-08-MMC
First Posted: September 19, 2008    Key Record Dates
Last Update Posted: August 10, 2012
Last Verified: August 2012
Keywords provided by Meir Medical Center:
widespread pain
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action