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Completed

NCT Number: NCT00631319

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

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

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Key information

Conditions

Chronic Pain Arthralgia Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OROS hydromorphone

Drug

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

Placebo

Drug

Placebo

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

    Time frame: Baseline, Week 12

    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.

Other outcomes

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

    Time frame: Baseline to Week 12

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

    Time frame: Baseline to Week 12

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

    Time frame: Baseline to Week 12

  4. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score and Change From Baseline by Visit in the Double-blind Phase

    Time frame: Baseline to Week 12

  5. Patient Global Assessment and Change From Baseline by Visit in the Double-blind Phase

    Time frame: Baseline to Week 12

  6. Time to Treatment Failure From Baseline

    Time frame: within 12 weeks from Baseline

Sponsors and collaborators

Lead sponsor

Mallinckrodt

Industry

Registry information

Official study title

A Phase III, Flexible Dose Titration Followed by a Randomized Double-Blind Study of Controlled Release OROS Hydromorphone HCL Compared to Placebo in Patients With OA Pain

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 7, 2008
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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