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

This study is ongoing, but not recruiting participants.

First Received: February 28, 2008 Last Updated: February 10, 2009 History of Changes

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
Estimated Study Completion Date:	April 2009
Estimated 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

Additional Information:

sponsor home page This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Neuromed Pharmaceuticals ( Neuromed Pharmaceuticals )
Study ID Numbers:	NMT 1077-302
Study First Received:	February 28, 2008
Last Updated:	February 10, 2009
ClinicalTrials.gov Identifier:	NCT00631319 History of Changes
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

Study placed in the following topic categories:

Hydromorphone
Osteoarthritis
Central Nervous System Depressants
Narcotics
Pain

Peripheral Nervous System Agents
Analgesics
Arthralgia
Analgesics, Opioid
Acetaminophen

Additional relevant MeSH terms:

Hydromorphone
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 July 02, 2009