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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

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 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.

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 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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