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

Tracking Information
First Received Date ^ICMJE	February 28, 2008
Last Updated Date	February 10, 2009
Start Date ^ICMJE	February 2008
Estimated 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 (submitted: June 2, 2008)	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.
Change History	Complete list of historical versions of study NCT00631319 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

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
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Chronic Pain
Intervention ^ICMJE	Drug: OROS HYDROMORPHONE
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	400
Estimated Completion Date	April 2009
Estimated 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	United States

Administrative Information
NCT ID ^ICMJE	NCT00631319
Responsible Party	Neuromed Pharmaceuticals, Neuromed Pharmaceuticals
Study ID Numbers ^ICMJE	NMT 1077-302
Study Sponsor ^ICMJE	Neuromed Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Neuromed Pharmaceuticals
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP