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

Mallinckrodt

Status and phase: Completed; Phase 3

Conditions: Chronic Pain

Treatments: Drug: OROS hydromorphone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00631319

NMT 1077-302

Details and patient eligibility

About

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

Enrollment: 343 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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343 participants in 2 patient groups, including a placebo group

OROS Hydromorphone

Experimental group

Description:

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

Treatment:

Drug: OROS hydromorphone

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo