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| Sponsored by: |
Stony Brook University |
|---|---|
| Information provided by: | Stony Brook University |
| ClinicalTrials.gov Identifier: | NCT00790270 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Strain |
Drug: Cyclobenzaprine Drug: Ibuprofen Drug: Ibuprofen plus Cyclobenzaprine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A RCT |
| Enrollment: | 61 |
| Study Start Date: | January 2003 |
| Study Completion Date: | January 2004 |
| Primary Completion Date: | January 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Cyclobenzaprine: Active Comparator |
Drug: Cyclobenzaprine
5 mg orally every 8 hours as needed
|
| Ibuprofen: Active Comparator |
Drug: Ibuprofen
Ibuprofen 400 mg every 8 hours as needed
|
| Ibuprophen plus Cyclobenzaprine: Experimental |
Drug: Ibuprofen plus Cyclobenzaprine
Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Stony Brook University | |
| Stony Brook, New York, United States, 11733 | |
| Principal Investigator: | adam singer, md | Stony Brook University |
More Information
| Responsible Party: | Stony Brook University ( Adam Singer, MD ) |
| Study ID Numbers: | SB2003-1234 |
| Study First Received: | November 12, 2008 |
| Last Updated: | November 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00790270 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Cervical strain whiplash ibuprofen cyclobenzaprine |
|
Anti-Inflammatory Agents Neurotransmitter Agents Ibuprofen Tranquilizing Agents Adrenergic Agents Cyclooxygenase Inhibitors Psychotropic Drugs Wounds and Injuries Central Nervous System Depressants Disorders of Environmental Origin Antidepressive Agents, Tricyclic |
Cyclobenzaprine Analgesics, Non-Narcotic Muscle Relaxants, Central Amitriptyline Anti-Inflammatory Agents, Non-Steroidal Neck Injuries Analgesics Peripheral Nervous System Agents Antirheumatic Agents Antidepressive Agents Whiplash Injuries |
|
Anti-Inflammatory Agents Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Neuromuscular Agents Sensory System Agents Therapeutic Uses Muscle Relaxants, Central Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Neck Injuries Antidepressive Agents Ibuprofen Tranquilizing Agents Cyclooxygenase Inhibitors Wounds and Injuries Central Nervous System Depressants Enzyme Inhibitors Pharmacologic Actions Cyclobenzaprine Antidepressive Agents, Tricyclic Analgesics, Non-Narcotic Amitriptyline Peripheral Nervous System Agents Antirheumatic Agents |
