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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR NABUMETONE

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Clinical Trials for Nabumetone

Trial ID Title Status Sponsor Phase Summary
NCT00610610 Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome Completed GlaxoSmithKline Phase 4 Objective: Although there is a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited. We investigated whether a history of depressive and/or anxiety disorders was associated with response to treatment in a double blind, randomized, placebo controlled trial of paroxetine controlled release (CR) in fibromyalgia. Method: One hundred and sixteen fibromyalgia subjects were randomized to receive paroxetine CR (dose 12.5-62.5 mg/day) or placebo for 12 weeks. The Mini International Neuropsychiatric Interview (M.I.N.I-plus) was used to ascertain current or past diagnoses of depressive and anxiety disorders. Patients with current depressive or anxiety disorders were excluded, but those with past diagnoses were enrolled in the trial. Subjective depression and anxiety were assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI); subjects were excluded if they scored greater than 23 on the BDI. Health Status was determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale (SDS), the Perceived Stress Scale (PSS) and the Pittsburgh Sleep Quality Index (PSQI). The primary outcome was treatment response defined as ≥ 25% reduction in the Fibromyalgia Impact Questionnaire (FIQ) score. Secondary outcomes included changes in scores on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I respectively), the Visual Analogue Scale for Pain (VAS) scores and number of tender points.
NCT00610610 Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome Completed Duke University Phase 4 Objective: Although there is a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited. We investigated whether a history of depressive and/or anxiety disorders was associated with response to treatment in a double blind, randomized, placebo controlled trial of paroxetine controlled release (CR) in fibromyalgia. Method: One hundred and sixteen fibromyalgia subjects were randomized to receive paroxetine CR (dose 12.5-62.5 mg/day) or placebo for 12 weeks. The Mini International Neuropsychiatric Interview (M.I.N.I-plus) was used to ascertain current or past diagnoses of depressive and anxiety disorders. Patients with current depressive or anxiety disorders were excluded, but those with past diagnoses were enrolled in the trial. Subjective depression and anxiety were assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI); subjects were excluded if they scored greater than 23 on the BDI. Health Status was determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale (SDS), the Perceived Stress Scale (PSS) and the Pittsburgh Sleep Quality Index (PSQI). The primary outcome was treatment response defined as ≥ 25% reduction in the Fibromyalgia Impact Questionnaire (FIQ) score. Secondary outcomes included changes in scores on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I respectively), the Visual Analogue Scale for Pain (VAS) scores and number of tender points.
NCT00688961 Effects of Omacor and Aspirin on Platelet Function Completed Sanford Research Phase 0 Omacor (now Lovaza) is a pharmaceutical omega-3 fatty acid product. Omega-3 fatty acids can affect blood clotting by altering the function of the blood platelets. Aspirin can do the same. The purpose of this study is to determine the individual and combined effects of these two agents on platelet function using a whole blood method.
NCT00864604 Single Dose Two-Way Crossover Fed Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers Completed Actavis Inc. Phase 1 The purpose of this study is to evaluate the relative bioavailability of two formulations of nabumetone tablets to establish their average bioequivalence
NCT00864968 Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers Completed Actavis Inc. Phase 1 The purpose of this study is to evaluate the relative bioavailability of nabumetone from 2 tablet products and determine if the 2 products were bioequivalent to each other.
NCT01164813 Bioequivalence Study of Nabumetone 750 mg Tablets of Dr. Reddy's Under Fasting Conditions Completed Dr. Reddy's Laboratories Limited Phase 1 The purpose of this study is: - To Assess the bioequivalence study of Nabumetone 750 mg tablets and Relafen® 750 mg tablets in healthy, adult, human subjects under fasting conditions with a washout period of 14 days. - To monitor adverse events and ensure the safety of subjects.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Nabumetone

Condition Name

Condition Name for Nabumetone
Intervention Trials
Healthy 5
Atrial Fibrillation 1
Osteoarthritis, Knee 1
Fibromyalgia Syndrome 1
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Condition MeSH

Condition MeSH for Nabumetone
Intervention Trials
Myofascial Pain Syndromes 1
Atrial Fibrillation 1
Fibromyalgia 1
Disease 1
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Clinical Trial Locations for Nabumetone

Trials by Country

Trials by Country for Nabumetone
Location Trials
United States 6
India 2
Brazil 1
Denmark 1
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Trials by US State

Trials by US State for Nabumetone
Location Trials
North Carolina 3
Texas 1
South Dakota 1
Pennsylvania 1
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Clinical Trial Progress for Nabumetone

Clinical Trial Phase

Clinical Trial Phase for Nabumetone
Clinical Trial Phase Trials
Phase 4 2
Phase 2 1
Phase 1 4
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Clinical Trial Status

Clinical Trial Status for Nabumetone
Clinical Trial Phase Trials
Completed 8
Recruiting 1
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Clinical Trial Sponsors for Nabumetone

Sponsor Name

Sponsor Name for Nabumetone
Sponsor Trials
Dr. Reddy's Laboratories Limited 2
Actavis Inc. 2
Duke University 1
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Sponsor Type

Sponsor Type for Nabumetone
Sponsor Trials
Other 11
Industry 5
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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
Harvard Business School
Healthtrust
Medtronic
Farmers Insurance
Queensland Health
McKesson
Daiichi Sankyo

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