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

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

This study is currently recruiting participants.
Verified by Neuromed Pharmaceuticals, July 2008

Sponsored by:	Neuromed Pharmaceuticals
Information provided by:	Neuromed Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00631319

Purpose

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

Condition	Intervention	Phase
Chronic Pain	Drug: OROS Hydromorphone	Phase III

MedlinePlus related topics:

Osteoarthritis

ChemIDplus related topics:

Hydromorphone Hydromorphone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Official Title:	A Phase III, Flexible Dose Titration Follwed by a Randomized Double-Blind Study of Controlled Release OROS Hydromorphone HCL Compared to Placebo in Patients With Chronic OA Pain

Further study details as provided by Neuromed Pharmaceuticals:

Primary Outcome Measures:

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.

Estimated Enrollment:	400
Study Start Date:	February 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 replacment surgery within the next 6 months
Patients who have major depression or anxiety
Women who are pregnant or breast feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631319

Contacts


Contact: Tracey L Johnson	484.533.6916	tjohnson@neuromed.com

Contact: Carole Hodge		hodgecarole@praintl.com

Locations


United States, Pennsylvania
	Tracey Johnson	Recruiting
	Philadelephia, Pennsylvania, United States
	Contact: Tracey johnson 484-533-6916 tjohnson@neuromed.com

Sponsors and Collaborators

Neuromed Pharmaceuticals

More Information

sponsor home page This link exits the ClinicalTrials.gov site

Responsible Party:	Neuromed Pharmaceuticals ( Neuromed Pharmaceuticals )
Study ID Numbers:	NMT 1077-302
First Received:	February 28, 2008
Last Updated:	July 30, 2008
ClinicalTrials.gov Identifier:	NCT00631319
Health Authority:	United States: Food and Drug Administration

Keywords provided by Neuromed Pharmaceuticals:

Chronic Pain

Osteoarthritis

OA Pain

Osteoarthritis Pain

Pain

Hip Pain

Knee Pain

Joint Pain

Study placed in the following topic categories:

Hydromorphone

Osteoarthritis

Pain

Arthralgia

Additional relevant MeSH terms:

Sensory System Agents

Therapeutic Uses

Physiological Effects of Drugs

Central Nervous System Depressants

Narcotics

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

Pharmacologic Actions

Analgesics, Opioid

ClinicalTrials.gov processed this record on August 28, 2008