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

This study has been completed.

First Received on February 28, 2008. Last Updated on August 26, 2010 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Hydromorphone hydrochloride Hydromorphone

U.S. FDA Resources

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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	February 2008
Study Completion Date:	June 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Intervention Details:

QD opioid pain reliever for OA pain-patients.

Eligibility

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 replacement 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

Locations

United States, Pennsylvania
Tracey Johnson
Philadelphia, Pennsylvania, United States, 19428

Sponsors and Collaborators

Neuromed Pharmaceuticals

More Information

No publications provided

Responsible Party:	Neuromed Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00631319 History of Changes
Other Study ID Numbers:	NMT 1077-302
Study First Received:	February 28, 2008
Last Updated:	August 26, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Neuromed Pharmaceuticals:

OA
Chronic Pain
Osteoarthritis
OA Pain
Osteoarthritis Pain

Pain
Hip Pain
Knee Pain
Joint Pain

Additional relevant MeSH terms:

Hydromorphone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on February 13, 2012