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

Mallinckrodt343 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

343

Conditions

Chronic Pain

Interventions

OROS hydromorphoneDRUG

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

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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.

Time frame: Baseline, Week 12

Data from ClinicalTrials.gov

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