An Effectiveness and Safety Study of Cyclobenzaprine HCl Alone or in Combination With Ibuprofen for Acute Back or Neck Muscle Pain With Muscle Spasm
Information source: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Spasm; Pain
Intervention: cyclobenzaprine hydrochloride (Drug)
Phase: Phase 4
Sponsored by: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Official(s) and/or principal investigator(s):
McNeil Consumer & Specialty Pharmaceuticals Clinical Trial, Study Director, Affiliation: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
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.
Official title: FlexerilŽ (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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Subject-rated global impression of change from baseline, after seven days of treatment
Secondary outcome: Subject global impression of change after 3 days; Proportion of responders after 3 and 7 days, Change from baseline in subject-rated pain intensity, muscle spasm intensity, functional ability, and medication helpfulness after 3 and 7 days.
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.
Minimum age: 18 Years.
Maximum age: 65 Years.
- 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
- 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.)
- 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
Locations and Contacts
Ending date: July 2004
Last updated: May 11, 2007