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

Phase 3

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Drug: Placebo; Drug: OROS hydromorphone

• Registration Number: NCT00549042
• Lead Sponsor: Mallinckrodt

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-23
• Study First Submitted QC: 2007-10-23
• Study First Posted: 2007-10-25
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2019-02
• Disposition First Submitted: 2019-02-25
• Disposition First Submitted QC: 2019-02-25
• Disposition First Posted: 2019-02-28
• Results First Submitted: 2020-05-31
• Results First Submitted QC: 2020-05-31
• Last Update Submitted: 2020-05-31
• Results First Posted: 2020-06-17
• Last Update Posted: 2020-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 459

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).
OROS hydromorphone	OROS hydromorphone	OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 12 in Mean Pain Intensity	Baseline, Week 12 (or final visit)	Participants rate their pain intensity on a numeric rating scale (NRS), where 0=no pain and 10=worst possible pain, in a daily diary. At Week 12 (or final visit), all measurements during the preceding week are averaged, and the mean change from the mean score at baseline is calculated.