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
Sponsored by: Mallinckrodt
To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain
in patients with Osteoarthritis (OA) Pain
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.
- 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
- Joint replacement of the hip or of the knee that is the primary source of OA Pain
- History drug or alcohol abuse
- 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
Starting date: February 2008
Last updated: March 20, 2012