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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 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.

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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.

Conditions Studied

Back Pain

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

FieldValue
Enrollment Target 108 participants
Start Date 2008-09
Est. Completion 2009-12
Phase Phase 3

Sponsor

Ortho-McNeil Janssen Scientific Affairs

7 total trials

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What the Registry Record Tells You About NCT00771758

The ClinicalTrials.gov registry entry for NCT00771758 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 140-participant average among 37 other Back Pain trials with a reported enrollment target (23% lower). The listed sponsor is Ortho-McNeil Janssen Scientific Affairs, which has 7 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.