A Study to Compare the Frequency of Constipation Symptoms With Tapentadol Immediate Release (IR) Treatment Versus Oxycodone IR Treatment in Patients With End-stage Joint Disease

Phase 3 Completed 597 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Grünenthal GmbH · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare bowel function/constipation that occurs during tapentadol treatment with that occuring during oxycodone treatment, as measured by the frequency of spontaneous bowel movements per week. The frequency of spontaneous bowel movements will be determined from a Bowel Function Patient Diary completed by the enrolled sujbects.

Timeline

Start: 2008-10
Primary completion: 2009-07
Completion: 2009-07

Outcome

Met primary endpoint

registry Placebo vs Tapentadol 50 mg; p = 0.007; Difference in Least-Squares Means 55.1 (95% CI 15.11 to 95.13) NCT00784277 ↗

registry Tapentadol 50 mg vs Oxycodone; p <0.001; Difference in Least-Squares Means 2.2 (95% CI 1.34 to 3.12) NCT00784277 ↗

Publications

Etropolski M, Kelly K, Okamoto A, Rauschkolb C. Comparable efficacy and superior gastrointestinal tolerability (nausea, vomiting, constipation) of tapentadol compared with oxycodone hydrochloride. Adv Ther. 2011 May;28(5):401-17. doi: 10.1007/s12325-011-0018-0. Epub 2011 Apr 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Oxycodone	Other / unclassified	10 mg	Oral
Comparator	Oxycodone	Other / unclassified	20 mg	Oral
Comparator	Oxycodone	Other / unclassified	60 mg	Oral
Subject	Tapentadol	Small molecule	50 mg	Oral
Subject	Tapentadol	Small molecule	75 mg	Oral
Subject	Tapentadol	Small molecule	100 mg	Oral
Subject	Tapentadol	Small molecule	500 mg	Oral