A Study to Evaluate the Effectiveness and Safety of Slow Release Hydromorphone HCL for Treatment of Patients With Osteoarthritis

NCT00411164 | Completed Phase 3

• 1 other identifier: CR013273
• Study Type: interventional
• Target: 990
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to compare the analgesic (a drug that relieves pain) effectiveness and safety of OROS hydromorphone HCI (slow release) 8 mg and 16 mg to placebo (no drug) in patients with osteoarthritis (OA).

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee

Keywords

knee pain; hip pain; opioid

Outcome Measures

Primary Outcomes (1)

• Time-interval weighted AUC pain ratio (AUC/by an individual's maximum possible benefit AUC)using Baseline Observation Carried Forward imputation(up to Week 12); AUC was the cumulative pain intensity differences from baseline (titration and maintenance).

Secondary Outcomes (1)

• WOMAC pain subscale for the AUC ratio and change from baseline at each time point; Index score and other subscale analyzed using the AUC ratio and change from baseline (no imputation, BOCF and LOCF imputation); Other included MOS Sleep Scale.

Interventions

OROS hydromorphone HCI (slow release) DRUG

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have a negative pregnancy test at screening and be postmenopausal for at least 1 year or surgically sterile or practicing a medically recognized contraceptive program
• Patient has been diagnosed with Functional Class I-III Osteoarthritis of the knee or hip
• Patient has required treatment of target joint pain within the 90 days prior to study start and met at least one of the following: was unable to consistently control target joint pain with non-opioid pain reliever, unable to treat target joint pain with non-opioid pain reliever because treatment was contraindicated per investigator judgement, or had received an opioid(single or combination product) for treatment of target joint pain, with the equivalent of less than or equal to 40 mg/day of oral morphine sulfate, inclusive of breakthrough pain medication
• Patient has reported a target joint pain score of at least 5 (11-point Likert Scale) at baseline

You may not qualify if:

• Patient for whom hydromorphone was contraindicated because of a documented history of an allergic reaction (hives, rash, etc) or a clinically significant intolerance to hydromorphone or other opioids
• Patient requiring treatment with monoamine oxidase inhibitors, or receiving systemic chemotherapy or had an active malignancy of any type or had clinically significant abnormalities in clinical chemistry, hematology or urinalysis, or had a documented history of gout, pseudogout, Paget's disease, fibromyalgia
• uncontrolled inflammatory arthritis or NSAID-dependent inflammatory arthritis or any chronic pain syndrome that could interfere with the assessment of pain and/or other symptoms of osteoarthritis
• Patient who is pregnant and/or breastfeeding
• Patient with a documented history of drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse, or unable to discontinue all formulations of prior pain medications (opioid and/or non-opioid) during the washout period of the study
• Patient who had a documented history of a medical condition, which, in the investigator's opinion, could compromise the patient's ability to swallow, absorb, metabolize, or excrete study drug, including (but not limited to) intractable nausea and/or vomiting, and/or severe gastrointestinal narrowing

Sponsors & Collaborators

• Alza Corporation, DE, USA: lead

Related Links

• A Phase 3, Randomized, Double-Blind, Fixed-Dose, Parallel-group Comparison of Controlled-Release Hydromorphone HCl vs. Placebo in Patients with Osteoarthritis

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Alza Corporation Clinical Trial

  ALZA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2006
• First Posted: December 13, 2006
• Study Start: November 1, 2003
• Study Completion: May 1, 2005
• Last Updated: July 8, 2013

Record last verified: 2013-07