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

History of Changes

Tracking Information
First Received Date ^ICMJE	February 28, 2008
Last Updated Date	March 20, 2012
Start Date ^ICMJE	February 2008
Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 10, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00631319 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic OA Pain
Official Title ^ICMJE	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
Brief Summary	To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in patients with Osteoarthritis (OA) Pain
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Chronic Pain
Intervention ^ICMJE	Drug: OROS HYDROMORPHONE QD opioid pain reliever for OA pain-patients.
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	200
Completion Date	June 2009
Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	30 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00631319
Other Study ID Numbers ^ICMJE	NMT 1077-302
Has Data Monitoring Committee	No
Responsible Party	Mallinckrodt
Study Sponsor ^ICMJE	Mallinckrodt
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mallinckrodt
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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