drugset / Trial / NCT00225797

Efficacy and Safety of Oxmorphone Extended Release in Chronic Non-malignant Pain

NCT00225797 ↗

Phase 3 Completed 160 enrolled Endo USA Inc., a Keenova Therapeutics Company
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the analgesic efficacy and safety of oxymorphone extended release in non-cancer patients with chronic low back pain.

Timeline

Start
2004-11
Primary completion
—
Completion
2005-07

Outcome

Met primary endpoint

paper Pain intensity increased significantly more in the placebo group PMID 17257473 ↗

paper than in the oxymorphone ER group (LS mean change 10.0 +/- 2.4 [median 2.0]; p < 0.0001). PMID 17257473 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxymorphone Small molecule — Oral

Indications