An Effectiveness and Safety Study of Cyclobenzaprine HCl Alone or in Combination With Ibuprofen f… (NCT00246389) | Clinical Trial Compass
CompletedPhase 4
An Effectiveness and Safety Study of Cyclobenzaprine HCl Alone or in Combination With Ibuprofen for Acute Back or Neck Muscle Pain With Muscle Spasm
1,000 participants
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Experiencing neck or back pain for no more than 14 days
* Physician rating of the muscle spasm of the neck or back region as mild, moderate or severe
* Ability to discontinue all muscle relaxants, NSAIDs (anti-inflammatory drugs) and pain relievers, other than the study medications during the 7-day treatment period. (Cardioprotective doses of aspirin (\<= 325 mg / day) may be taken.)
Exclusion Criteria:
* History of physician-diagnosed musculoskeletal neck or back muscle spasms within 12 months prior to the study
* neck or back pain radiating into the arms or legs
* history of serious medical conditions
* taken a narcotic or muscle relaxant within 12 hours of the baseline physician visit
* allergies to aspirin, NSAIDs or cyclobenzaprine HCl.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Subject-rated global impression of change from baseline, after seven days of treatment
Trial details
NCT IDNCT00246389
SponsorMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.