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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: February 28, 2008
Last updated: March 20, 2012
Last verified: March 2012
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
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:

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:
    QD opioid pain reliever for OA pain-patients.

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Chronic Pain
OA Pain
Osteoarthritis Pain
Hip Pain
Knee Pain
Joint Pain

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

ClinicalTrials.gov processed this record on November 24, 2015