Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain - Full Text View

Purpose

This study is designed to evaluate the safety and efficacy of RGH-896 in patients with diabetic peripheral neuropathic pain.

Condition	Intervention	Phase
Diabetic Peripheral Neuropathic Pain	Drug: RGH-896 Drug: pregabalin Drug: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo- and Active-Controlled Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain

Resource links provided by NLM:

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Change in mean daily pain rating [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

50% reduction in pain [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]

Enrollment:	458
Study Start Date:	February 2009
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: RGH-896 45 mg TID, capsules, 14 weeks.
Experimental: 2	Drug: RGH-896 30 mg TID, capsules, 14 weeks.
Experimental: 3	Drug: RGH-896 15 mg TID, capsules, 14 weeks.
Active Comparator: 4	Drug: pregabalin 100 mg, TID, capsules, 14 weeks. Other Name: Lyrica
Placebo Comparator: 5	Drug: placebo TID, capsules, 14 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female outpatients 18 to 75 years of age
A diagnosis of painful diabetic neuropathy
Controlled blood glucose
Willingness to wash out all analgesic medications used for DPNP
Female patients either postmenopausal, surgically sterile, or practicing a medically acceptable method of contraception
Female patients who are not pregnant

Exclusion Criteria:

Acute infections or cardiac problems
Past use of pregabalin
History of severe psychiatric disorder
History of any amputation due to diabetes
History of seizure disorder
Active diabetic foot ulcers

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838799

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Locations

United States, Alabama
Forest Investigative Site
Birmingham, Alabama, United States, 35242
United States, Arizona
Forest Investigative Site
Mesa, Arizona, United States, 85210
Forest Investigative Site
Tempe, Arizona, United States, 85282
United States, Arkansas
Forest Investigative Site
Jonesboro, Arkansas, United States, 72401
Forest Investigative Site
Little Rock, Arkansas, United States, 72205
Forest Investigative Site
North Little Rock, Arkansas, United States, 72114
United States, California
Forest Investigative Site
Anaheim, California, United States, 92801
Forest Investigative Site
Burbank, California, United States, 91505
Forest Investigative Site
Lakewood, California, United States, 90712
Forest Investigative Site
National City, California, United States, 91950
Forest Investigative Site
Riverside, California, United States, 92506
Forest Investigative Site
Sacramento, California, United States, 95821
Forest Investigative Site
San Diego, California, United States, 92117
Forest Investigative Site
Santa Monica, California, United States, 90404
Forest Investigative Site
Tustin, California, United States, 92780
Forest Investigative Site
Walnut Creek, California, United States, 94598
Forest Investigative Site
Westlake Village, California, United States, 91361
United States, Colorado
Forest Investigative Site
Boulder, Colorado, United States, 80304
United States, Connecticut
Forest Investigative Site
New Britain, Connecticut, United States, 06050
United States, Florida
Forest Investigative Site
Bradenton, Florida, United States, 34203
Forest Investigative Site
Brandon, Florida, United States, 33511
Forest Investigative Site
DeLand, Florida, United States, 32720
Forest Investigative Site
Hollywood, Florida, United States, 33023
Forest Investigative Site
Jacksonville, Florida, United States, 32216
Forest Investigative Site
Miami, Florida, United States, 33108
Forest Investigative Site
Orlando, Florida, United States, 32806
Forest Investigative Site
Pembroke Pines, Florida, United States, 33024
Forest Investigative Site
Tampa, Florida, United States, 33606
Forest Investigative Site
West Palm Beach, Florida, United States, 33401
United States, Hawaii
Forest Investigative Site
Honolulu, Hawaii, United States, 96814
United States, Idaho
Forest Investigative Site
Boise, Idaho, United States, 83642
United States, Kansas
Forest Investigative Site
Wichita, Kansas, United States, 67203
United States, Louisiana
Forest Investigative Site
Covington, Louisiana, United States, 70433
United States, Maryland
Forest Investigative Site
Owings Mills, Maryland, United States, 21117
United States, Missouri
Forest Investigative Site
St. Louis, Missouri, United States, 63141
United States, New Jersey
Forest Investigative Site
West Caldwell, New Jersey, United States, 07006
United States, New Mexico
Forest Investigative Site
Albuquerque, New Mexico, United States, 87108
United States, New York
Forest Investigative Site
New York, New York, United States, 10004
United States, North Carolina
Forest Investigative Site
Charlotte, North Carolina, United States, 28211
Forest Investigative Site
Greenville, North Carolina, United States, 27834
Forest Investigative Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Forest Investigative Site
Cleveland, Ohio, United States, 44122
Forest Investigative Site
Kettering, Ohio, United States, 45429
United States, Oklahoma
Forest Investigative Site
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Forest Investigative Site
Duncansville, Pennsylvania, United States, 16635
Forest Investigative Site
Philadelphia, Pennsylvania, United States, 19139
United States, South Carolina
Forest Investigative Site
Columbia, South Carolina, United States, 29201
United States, Tennessee
Forest Investigative Site
Memphis, Tennessee, United States, 38119
United States, Texas
Forest Investigative Site
Dallas, Texas, United States, 75246
Forest Investigative Site
Lake Jackson, Texas, United States, 77566
Forest Investigative Site
San Antonio, Texas, United States, 78229
United States, Utah
Forest Investigative Site
Salt Lake City, Utah, United States, 84106
United States, Virginia
Forest Investigative Site
Virginia Beach, Virginia, United States, 23454
United States, Washington
Forest Investigative Site
Tacoma, Washington, United States, 98405

Sponsors and Collaborators

Forest Laboratories

Gedeon Richter Ltd.

Investigators

Study Director:

Allyson Gage, PhD

Forest Research Institute, a subsidiary of Forest Laboratories Inc.

More Information

No publications provided

Responsible Party:	James Perhach, Ph.D., Executive Director, Clinical Development, Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00838799 History of Changes
Other Study ID Numbers:	RG8-MD-02
Study First Received:	February 5, 2009
Last Updated:	July 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

diabetic
peripheral
neuropathic

pain
chronic
diabetes

Additional relevant MeSH terms:

Neuralgia
Diabetic Neuropathies
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus

Endocrine System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 22, 2013