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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00631319
First Posted: March 7, 2008
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Mallinckrodt
  Purpose
To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in patients with Osteoarthritis (OA) Pain

Condition Intervention Phase
Chronic Pain Drug: OROS HYDROMORPHONE Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mallinckrodt:

Primary Outcome Measures:
  • 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 ]

Enrollment: 200
Study Start Date: February 2008
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: OROS HYDROMORPHONE
    QD opioid pain reliever for OA pain-patients.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT00631319     History of Changes
Other Study ID Numbers: NMT 1077-302
First Submitted: February 28, 2008
First Posted: March 7, 2008
Last Update Posted: October 12, 2017
Last Verified: March 2012

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

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