An Effectiveness and Safety Study of Cyclobenzaprine HCl Alone or in Combination With Ibuprofen for Acute Back or Neck Muscle Pain With Muscle Spasm

Phase 4 Completed 1000 enrolled McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: —
Primary completion: —
Completion: 2004-07

Outcome

Missed primary endpoint

paper combination therapy with cyclobenzaprine 5 mg TID plus ibuprofen was not superior to cyclobenzaprine 5 mg TID alone PMID 16197668 ↗

Publications

Results Childers MK, Borenstein D, Brown RL, Gershon S, Hale ME, Petri M, Wan GJ, Laudadio C, Harrison DD. Low-dose cyclobenzaprine versus combination therapy with ibuprofen for acute neck or back pain with muscle spasm: a randomized trial. Curr Med Res Opin. 2005 Sep;21(9):1485-93. doi: 10.1185/030079905X61938.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	cyclobenzaprine	Unknown	5 mg	Oral

Indications

No indication recorded.