CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 459 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/NCT00549042
NCT00549042Phase 3Completed
CompareCT.gov

A Phase III, Variable-Dose Titration Followed by a Randomized Double-Blind Study of Controlled-Release OROS® Hydromorphone HCl (NMED-1077) Compared to Placebo in Patients With Chronic Low Back Pain

Mallinckrodt·interventional·Posted Oct 25, 2007·Updated Jun 17, 2020

In Brief

A Phase 3 clinical trial evaluating OROS hydromorphone and Placebo for Chronic Low Back Pain. Completed, enrolled 459 participants.

Detailed Summary

This study will test an experimental drug called OROS® hydromorphone hydrochloride (HCl) (NMED-1077), a once daily opioid analgesic that can relieve pain. A large number of clinical studies have been conducted to test this drug. OROS hydromorphone HCl is currently approved in both the US and Europe to treat chronic pain. The purpose of this study is to compare OROS hydromorphone to placebo to see if it is safe and efficacious.

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 25, 2007
Enrollment StartOct 1, 2007
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.7 years ago

Interventions

OROS hydromorphonedrug

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

Placebodrug

Placebo