Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis
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|ClinicalTrials.gov Identifier: NCT00771758|
Recruitment Status : Completed
First Posted : October 13, 2008
Results First Posted : April 7, 2011
Last Update Posted : May 9, 2014
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment|
Drug: oxycodone IR
Drug: tapentadol IR
The recruitment period for this outpatient, multicenter study occurred between August 28, 2008 and December 9, 2009.
The study was terminated prematurely due to slow enrollment after 108 of 600 subjects enrolled. Valid statistical conclusions cannot be made due to the low number of subjects.
|Pre-assignment Details||The study consisted of a screening/randomization period (one day) and a double blind active treatment period (10 days).|