CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 343 enrolled
Drug / intervention
OROS hydromorphone +1 moredrug
Likely dose
OROS hydromorphone 64 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.

Search/NCT00631319
NCT00631319Phase 3Completed

A Phase III, Flexible Dose Titration Followed by a Randomized Double-Blind Study of Controlled Release OROS Hydromorphone HCL Compared to Placebo in Patients With OA Pain

Mallinckrodt·interventional·Posted Mar 7, 2008·Updated Sep 16, 2020

In Brief

A Phase 3 clinical trial evaluating OROS hydromorphone and Placebo for Chronic Pain. Completed, enrolled 343 participants.

Detailed Summary

To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in patients with Osteoarthritis (OA) Pain

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 7, 2008
Enrollment StartFeb 1, 2008
Primary CompletionApr 1, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.3 years ago

Interventions

OROS hydromorphonedrug

hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets

Placebodrug

Placebo