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

Information source: Mallinckrodt
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Pain

Intervention: OROS HYDROMORPHONE (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Mallinckrodt


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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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.


Minimum age: 30 Years. Maximum age: 80 Years. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: February 2008
Last updated: March 20, 2012

Page last updated: August 23, 2015

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