A Study of the Efficacy and Safety of Tramadol HCl/Acetaminophen, Hydrocodone Bitartrate/Acetaminophen and Placebo in Patients With Pain From an Ankle Sprain With a Partial Torn Ligament

Phase 3 Completed 603 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PriCara, Unit of Ortho-McNeil, Inc. · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to explore the pain-relieving effects and safety of two analgesic treatment regimens as compared to placebo in patients experiencing acute musculoskeletal pain. Patients who are experiencing at least moderate acute musculoskeletal pain from an ankle sprain severe enough to require prescription pain relief medication will be randomized to receive either tramadol HCl/acetaminophen, hydrocodone bitartrate/acetaminophen or placebo.

Timeline

Start: 2003-12
Primary completion: —
Completion: 2004-10

Publications

Results Hewitt DJ, Todd KH, Xiang J, Jordan DM, Rosenthal NR; CAPSS-216 Study Investigators. Tramadol/acetaminophen or hydrocodone/acetaminophen for the treatment of ankle sprain: a randomized, placebo-controlled trial. Ann Emerg Med. 2007 Apr;49(4):468-80, 480.e1-2. doi: 10.1016/j.annemergmed.2006.08.030. Epub 2006 Nov 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	650 mg	Oral
Subject	Hydrocodone	Unknown	7.5 mg	Oral
Subject	Tramadol	Other / unclassified	75 mg	Oral

Indications

No indication recorded.