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

NCT ID: NCT00631319

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 343 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-06-30

Brief Summary

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

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

OROS Hydromorphone

OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg

Group Type: EXPERIMENTAL

OROS hydromorphone

Intervention Type: DRUG

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

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

OROS hydromorphone

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

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Primary clinic diagnosis of osteoarthritis pain of the hip or of the knee for at least 6 months
• Patients required daily opioid medication to treat their chronic osteoarthritis pain

Exclusion Criteria

• Joint replacement of the hip or of the knee that is the primary source of osteoarthritis Pain
• History drug or alcohol abuse
• Fibromyalgia
• Patients who have major depression or anxiety
• Women who are pregnant or breast feeding

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

NMT 1077-302

Identifier Type: -

Identifier Source: org_study_id