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

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ClinicalTrials.gov Identifier: NCT00631319
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : March 21, 2012
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

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
U.S. FDA Resources


Intervention Details:
    Drug: OROS HYDROMORPHONE
    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, 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

Responsible Party: Mallinckrodt
ClinicalTrials.gov 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:
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