A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic Osteoarthritis (OA) Pain

Phase 3

Completed

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

• Registration Number: NCT00631319
• Lead Sponsor: Mallinckrodt

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-28
• Study First Submitted QC: 2008-02-28
• Study First Posted: 2008-03-07
• Primary Completion: 2009-04
• Study Completion: 2009-06
• Disposition First Submitted: 2019-03-07
• Disposition First Submitted QC: 2019-03-07
• Disposition First Posted: 2019-03-12
• Status Verified: 2020-08
• Results First Submitted: 2020-08-12
• Results First Submitted QC: 2020-08-12
• Results First Posted: 2020-08-26
• Last Update Submitted: 2020-08-27
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 343

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
Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity Change From Baseline to Week 12 or Final Visit of the Double-blind Phase	Baseline, Week 12	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.