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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00631319
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : March 21, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: OROS HYDROMORPHONE Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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 Chronic OA Pain
Study Start Date : February 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Intervention Details:
    QD opioid pain reliever for OA pain-patients.

Primary Outcome Measures :
  1. Mean change from baseline to week 12 (or last visit) of the average PI of the DB treatment based on weekly avrg. PI scores from the patient diary. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Primary clinic diagnosis of OA pain of the hip or of the knee for at least 6 months
  • Patients required daily opioid medication to treat their chronic OA pain

Exclusion Criteria:

  • Joint replacement of the hip or of the knee that is the primary source of OA Pain
  • History drug or alcohol abuse
  • Fibromyalgia
  • Patients who plan to have joint replacement surgery within the next 6 months
  • Patients who have major depression or anxiety
  • Women who are pregnant or breast feeding

Responsible Party: Mallinckrodt Identifier: NCT00631319     History of Changes
Other Study ID Numbers: NMT 1077-302
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: March 21, 2012
Last Verified: March 2012

Keywords provided by Mallinckrodt:
Chronic Pain
OA Pain
Osteoarthritis Pain
Hip Pain
Knee Pain
Joint Pain

Additional relevant MeSH terms:
Chronic Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents