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Last Updated: October 18, 2019

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CLINICAL TRIALS PROFILE FOR FLEXERIL

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Clinical Trials for Flexeril

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00246389 An Effectiveness and Safety Study of Cyclobenzaprine HCl Alone or in Combination With Ibuprofen for Acute Back or Neck Muscle Pain With Muscle Spasm Completed McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. Phase 4 1969-12-31 The purpose of this study is to evaluate the effectiveness and safety of cyclobenzaprine HCl 5 mg (muscle spasm medication) taken three times a day, alone or in combination with ibuprofen 400 mg or 800 mg (pain relief medication) taken three times a day, for the treatment of back or neck muscle pain with muscle spasm.
NCT00610610 Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome Completed GlaxoSmithKline Phase 4 2002-01-01 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 2002-01-01 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.
NCT00778037 Bioequivalence Study of Cyclobenzaprine Hydrochloride 10 mg Tablets, USP Under Fasting Conditions Completed Ranbaxy Laboratories Limited N/A 2006-09-01 To compare the single-dose oral bioavailability of Cyclobenzaprine hydrochloride 10 mg tablet of Ohm Labs Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc USA.) with Flexeril® 10 mg tablet (containing Cyclobenzaprine hydrochloride 10 mg) of McNeil Consumer & Specialty Pharmaceuticals, in healthy, adult, male, human subjects under fasting condition.
NCT00790270 Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial Completed Stony Brook University Phase 2 2003-01-01 The purpose of this study is to see whether the combination of a muscle relaxant and anti-inflammatory drug is more effective at relieving pain in patients with neck strains or whiplash than either of the two medications alone.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Flexeril

Condition Name

Condition Name for Flexeril
Intervention Trials
Pain 2
Urethral Sphincter Activity 1
Head and Neck Cancer 1
Spasm 1
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Condition MeSH

Condition MeSH for Flexeril
Intervention Trials
Pain, Postoperative 2
Breast Neoplasms 1
Myalgia 1
Head and Neck Neoplasms 1
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Clinical Trial Locations for Flexeril

Trials by Country

Trials by Country for Flexeril
Location Trials
United States 8
India 1
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Trials by US State

Trials by US State for Flexeril
Location Trials
Georgia 1
California 1
Michigan 1
Illinois 1
Alabama 1
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Clinical Trial Progress for Flexeril

Clinical Trial Phase

Clinical Trial Phase for Flexeril
Clinical Trial Phase Trials
Phase 4 3
Phase 2 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Flexeril
Clinical Trial Phase Trials
Completed 5
Not yet recruiting 1
Terminated 1
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Clinical Trial Sponsors for Flexeril

Sponsor Name

Sponsor Name for Flexeril
Sponsor Trials
Damon Runyon Cancer Research Foundation 1
GlaxoSmithKline 1
NorthShore University HealthSystem Research Institute 1
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Sponsor Type

Sponsor Type for Flexeril
Sponsor Trials
Other 7
Industry 6
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