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Sponsored by: |
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
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Information provided by: | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
ClinicalTrials.gov Identifier: | NCT00246389 |
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.
Condition | Intervention | Phase |
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Spasm Pain |
Drug: cyclobenzaprine hydrochloride |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Flexeril® (Cyclobenzaprine Hydrochloride) Community Based Study - An Evaluation of Cyclobenzaprine HCl Monotherapy and in Combination With Ibuprofen for Acute Back or Neck Muscle Pain With Muscle Spasm |
Estimated Enrollment: | 1000 |
Estimated Study Completion Date: | July 2004 |
The objective of this multicenter, randomized, open-label, parallel-group, one-week study is to evaluate the effectiveness and safety of cyclobenzaprine HCl 5 mg three times a day for one week, alone or in combination with ibuprofen 400 mg or 800 mg taken three times a day, for acute back or neck muscle pain with muscle spasm. The primary measurement of efficacy is the subject-rated global impression of change after seven days of treatment, compared to baseline. Safety assessments during the study include the monitoring of adverse events, and a physical examination, assessment of vital signs and medical history of any present illnesses conducted during the baseline visit. The study hypothesis is that there will not be a statistically significant difference in patient ratings of global impression of change, muscle spasm, muscle pain, medication helpfulness, and functional ability, between the cyclobenzaprine HCl monotherapy group versus the cyclobenzaprine HCl/ibuprofen 400 mg and cyclobenzaprine HCl/ibuprofen 800 mg groups, for the treatment for acute back or neck muscle pain with spasm.
Patients receive cyclobenzaprine HCl 5 mg administered orally three times a day for one week, or cyclobenzaprine HCl 5 mg with ibuprofen 400 mg administered orally three times a day for one week, or cyclobenzaprine HCl 5 mg with ibuprofen 800 mg administered orally three times a day for one week.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | McNeil Consumer & Specialty Pharmaceuticals Clinical Trial | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
Study ID Numbers: | CR002884 |
Study First Received: | October 28, 2005 |
Last Updated: | May 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00246389 |
Health Authority: | United States: Institutional Review Board |
cyclobenzaprine hydrochloride muscle spasm |
Spasm Signs and Symptoms Ibuprofen Amitriptyline |
Neurologic Manifestations Pain Cyclobenzaprine |
Neuromuscular Manifestations Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants |
Neuromuscular Agents Pharmacologic Actions Antidepressive Agents, Tricyclic Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Muscle Relaxants, Central Analgesics Peripheral Nervous System Agents Central Nervous System Agents Antidepressive Agents |