Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT00631319
First received: February 28, 2008
Last updated: March 20, 2012
Last verified: March 2012

February 28, 2008
March 20, 2012
February 2008
April 2009   (final data collection date for primary outcome measure)
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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00631319 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic OA Pain
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Pain
Drug: OROS HYDROMORPHONE
QD opioid pain reliever for OA pain-patients.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
June 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00631319
NMT 1077-302
No
Mallinckrodt
Mallinckrodt
Not Provided
Not Provided
Mallinckrodt
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP