NCT00549042

Study to Test the Effectiveness of Controlled-Release OROS® Hydromorphone HCl Compared to Placebo in Patients With Chronic Low Back Pain

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 459 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
DRUG	OROS hydromorphone	hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets
DRUG	Placebo	Placebo

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2007-10-25
• Last updated: 2020-06-17
• Results posted: 2020-06-17