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

This study is currently recruiting participants.

Verified by Forest Laboratories, April 2009

First Received: February 5, 2009 Last Updated: April 24, 2009 History of Changes

Sponsors and Collaborators:	Forest Laboratories Gedeon Richter Ltd.
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00838799

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 II

Drug Information available for: Pregabalin

U.S. FDA Resources

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

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Change in mean daily pain rating [ Time Frame: Baseline to end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

50% reduction in pain [ Time Frame: Baseline to end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	425
Study Start Date:	February 2009
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female outpatients 18 to 70 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

Contacts

Contact: Sandra Beaird, PhD

1-800-678-1605 ext 66297

info@forestpharm.com

Show 50 Study Locations

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:	Forest Research Institute, a subsidiary of Forest Laboratories, Inc. ( James Perhach, Ph.D., Executive Director, Clinical Development )
Study ID Numbers:	RG8-MD-02
Study First Received:	February 5, 2009
Last Updated:	April 24, 2009
ClinicalTrials.gov Identifier:	NCT00838799 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

diabetic
peripheral
neuropathic

pain
chronic
diabetes

Study placed in the following topic categories:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus
Pregabalin
Endocrine System Diseases

Pain
Peripheral Nervous System Agents
Analgesics
Endocrinopathy
Anticonvulsants
Diabetes Complications

Additional relevant MeSH terms:

Diabetic Neuropathies
Nervous System Diseases
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Pregabalin
Pharmacologic Actions
Neuromuscular Diseases

Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Diseases
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Diabetes Complications

ClinicalTrials.gov processed this record on May 06, 2009