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NCT00771758 · ClinicalTrials.gov registry record · Phase 3
Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis
A Phase 3 study of Back Pain, sponsored by Ortho-McNeil Janssen Scientific Affairs.
- Completed
- Registry status
- Phase 3
- Development phase
- 108
- Enrollment target
- 20
- Study locations
NCT00771758: Completed Phase 3 study of Back Pain, sponsored by Ortho-McNeil Janssen Scientific Affairs.
NCT00771758 is a Phase 3 study of Back Pain that has completed, run by Ortho-McNeil Janssen Scientific Affairs. The registered enrollment target is 108 participants, below the 140-participant average among 37 other Back Pain trials with a reported enrollment target (23% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00771758, a Phase 3 study of Back Pain, has completed, sponsored by Ortho-McNeil Janssen Scientific Affairs.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 108 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief. The study was terminated prematurely due to slow enrollment after 108 of 600 s
Conditions Studied
Interventions
- DRUG placebo
- DRUG oxycodone IR
- DRUG tapentadol IR
Study Locations (20)
California
- - Encinitas
- - Los Gatos
- - Mission Viejo
- - Oakland
- - Roseville
- - San Diego
- - Studio City
- - Vista
Florida
- - Bradenton
- - Hialeah
- - Kissimmee
- - Miami Springs
- - Ormond Beach
- - Saint Cloud
- - Vero Beach
Alabama
- - Haleyville
- - Tallassee
Arizona
- - Peoria
- - Tucson
Georgia
- - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2008-09 |
| Est. Completion | 2009-12 |
| Phase | Phase 3 |
What the finished NCT00771758 record still lists
NCT00771758 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 140-participant average among 37 other Back Pain trials with a reported enrollment target (23% lower).
The record links to 1 condition, with Back Pain appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT00771758 names 20 study sites across 5 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT00771758 about?
NCT00771758 is a clinical study titled "Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis". 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 a...
What is the current status of trial NCT00771758?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 108 participants. The study started on 2008-09. Estimated completion is 2009-12.
What conditions does trial NCT00771758 study?
This clinical trial studies the following conditions: Back Pain.
What interventions are being tested in trial NCT00771758?
The interventions under investigation include: placebo (DRUG), oxycodone IR (DRUG), tapentadol IR (DRUG).
Who is sponsoring clinical trial NCT00771758?
This trial is sponsored by Ortho-McNeil Janssen Scientific Affairs, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00771758 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00771758's enrollment target sits among peer trials
108 18th of 37 higher than 20 of 37 other Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Back Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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