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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT00631319
First received: February 28, 2008
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT00631319     History of Changes
Other Study ID Numbers: NMT 1077-302
Study First Received: February 28, 2008
Last Updated: March 20, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hydromorphone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on May 23, 2013