At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 108 enrolled
Drug / intervention
oxycodone IR +2 moredrug
Likely dose
oxycodone IR 450 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo- and Oxycodone Immediate Release (IR)-Controlled Study of Tapentadol IR for the Treatment of Acute Pain Caused by Vertebral Compression Fractures Associated With Osteoporosis
In Brief
A Phase 3 clinical trial evaluating oxycodone IR, placebo, and 1 other intervention for Back Pain. Completed, enrolled 108 participants across 37 sites.
Detailed Summary
The purpose of this study is to determine the effectiveness and safety of tapentadol immediate release (IR) as compared with placebo and oxycodone IR in patients with acute pain caused by vertebral compression fractures (VCF) associated with assumed osteoporosis for whom treatment with oral opioid analgesics is appropriate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBack Pain
CountriesUnited States
CollaboratorsGrünenthal GmbH
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2008
First PostedOct 2008
Primary CompletionDec 2009
TodayJul 2026
First PostedOct 13, 2008
Enrollment StartSep 1, 2008
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.7 years ago
Interventions
oxycodone IRdrug
maximum daily dose 450 mg
placebodrug
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days
tapentadol IRdrug
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days