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Study Assessing the Efficacy of Etoricoxib in Female Patients With Fibromyalgia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00755521
First received: September 18, 2008
Last updated: August 9, 2012
Last verified: August 2012
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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: December 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: B
Experimental: A
adding Etoricoxib to the basic therapeutic regimen
Drug: etoricoxib

Treating Fibromyalgia with etoricoxib

etoricoxib - 90mg

Other Name: Arcoxia

  Show Detailed Description

  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
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, see Learn About Clinical Studies.

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
Department of Medicine 'D', Meir Medical Center Recruiting
Kfar-Saba, Israel, 44281
Contact: Howard Amital, MD MHA    972-9-7472598    Howard.Amital@sheba.health.gov.il   
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Howard Amital, MD MHA Meir Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT00755521     History of Changes
Other Study ID Numbers: 0134-08-MMC
Study First Received: September 18, 2008
Last Updated: August 9, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
Fibromyalgia
tenderness
widespread pain
comrbidity

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Etoricoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014