Status:

COMPLETED

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

Lead Sponsor:

Mallinckrodt

Conditions:

Chronic Pain

Eligibility:

All Genders

30-80 years

Phase:

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Primary clinic diagnosis of osteoarthritis pain of the hip or of the knee for at least 6 months
  • Patients required daily opioid medication to treat their chronic osteoarthritis pain
  • Exclusion Criteria
  • Joint replacement of the hip or of the knee that is the primary source of osteoarthritis Pain
  • History drug or alcohol abuse
  • Fibromyalgia
  • Patients who have major depression or anxiety
  • Women who are pregnant or breast feeding

Exclusion

    Key Trial Info

    Start Date :

    February 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2009

    Estimated Enrollment :

    343 Patients enrolled

    Trial Details

    Trial ID

    NCT00631319

    Start Date

    February 1 2008

    End Date

    June 1 2009

    Last Update

    September 16 2020

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