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

Information source: Neuromed Pharmaceuticals
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Pain

Intervention: OROS Hydromorphone (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Neuromed Pharmaceuticals

Overall contact:
Tracey L Johnson, Phone: 484.533.6916, Email: tjohnson@neuromed.com

Summary

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 Follwed by a Randomized Double-Blind Study of Controlled Release OROS Hydromorphone HCL Compared to Placebo in Patients With Chronic OA Pain

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

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.

Eligibility

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

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 replacment surgery within the next 6 months

- Patients who have major depression or anxiety

- Women who are pregnant or breast feeding

Locations and Contacts

Tracey L Johnson, Phone: 484.533.6916, Email: tjohnson@neuromed.com

Tracey Johnson, Philadelephia, Pennsylvania, United States; Recruiting
Tracey johnson, Phone: 484-533-6916, Email: tjohnson@neuromed.com
Additional Information

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Starting date: February 2008
Last updated: July 30, 2008

Page last updated: November 03, 2008

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