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

NCT00631319 | Completed Phase 3 Results

• 1 other identifier: NMT 1077-302
• Study Type: interventional
• Target: 343
• Locations: 0 countries
• Sites: N/A

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

Keywords

OA; Chronic Pain; Osteoarthritis; OA Pain; Osteoarthritis Pain; Pain; Hip Pain; Knee Pain; Joint Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 12

Other Outcomes (6)

• Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity and Change From Baseline by Visit in the Double-blind Phase

  Baseline to Week 12

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score and Change From Baseline by Visit in the Double-blind Phase

  Baseline to Week 12

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score and Change From Baseline by Visit in the Double-blind Phase

  Baseline to Week 12

Study Arms (2)

OROS Hydromorphone

EXPERIMENTAL

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

Drug: OROS hydromorphone

Placebo

PLACEBO COMPARATOR

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).

Drug: Placebo

Interventions

OROS hydromorphone DRUG

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

OROS Hydromorphone

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mallinckrodt: lead

MeSH Terms

Conditions

Chronic Pain; Osteoarthritis; Pain; Arthralgia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Mallinckrodt

clinicaltrials@mnk.com

800-556-3314

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 7, 2008
• Study Start: February 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 16, 2020
• Results First Posted: August 26, 2020

Record last verified: 2020-08