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

Diabetic Peripheral Neuropathic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838799
• Other study ID #: RG8-MD-02
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2009
• Last updated: July 6, 2011
• Start date: February 2009

Study information

• Verified date: July 2011
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathic Pain
• Neuralgia

Intervention

Drug:
• RGH-896
45 mg TID, capsules, 14 weeks.
• RGH-896
30 mg TID, capsules, 14 weeks.
• RGH-896
15 mg TID, capsules, 14 weeks.
• pregabalin
100 mg, TID, capsules, 14 weeks.
• placebo
TID, capsules, 14 weeks.

Locations

Country	Name	City	State
United States	Forest Investigative Site	Albuquerque	New Mexico
United States	Forest Investigative Site	Anaheim	California
United States	Forest Investigative Site	Birmingham	Alabama
United States	Forest Investigative Site	Boise	Idaho
United States	Forest Investigative Site	Boulder	Colorado
United States	Forest Investigative Site	Bradenton	Florida
United States	Forest Investigative Site	Brandon	Florida
United States	Forest Investigative Site	Burbank	California
United States	Forest Investigative Site	Charlotte	North Carolina
United States	Forest Investigative Site	Cleveland	Ohio
United States	Forest Investigative Site	Columbia	South Carolina
United States	Forest Investigative Site	Covington	Louisiana
United States	Forest Investigative Site	Dallas	Texas
United States	Forest Investigative Site	DeLand	Florida
United States	Forest Investigative Site	Duncansville	Pennsylvania
United States	Forest Investigative Site	Greenville	North Carolina
United States	Forest Investigative Site	Hollywood	Florida
United States	Forest Investigative Site	Honolulu	Hawaii
United States	Forest Investigative Site	Jacksonville	Florida
United States	Forest Investigative Site	Jonesboro	Arkansas
United States	Forest Investigative Site	Kettering	Ohio
United States	Forest Investigative Site	Lake Jackson	Texas
United States	Forest Investigative Site	Lakewood	California
United States	Forest Investigative Site	Little Rock	Arkansas
United States	Forest Investigative Site	Memphis	Tennessee
United States	Forest Investigative Site	Mesa	Arizona
United States	Forest Investigative Site	Miami	Florida
United States	Forest Investigative Site	National City	California
United States	Forest Investigative Site	New Britain	Connecticut
United States	Forest Investigative Site	New York	New York
United States	Forest Investigative Site	North Little Rock	Arkansas
United States	Forest Investigative Site	Orlando	Florida
United States	Forest Investigative Site	Owings Mills	Maryland
United States	Forest Investigative Site	Pembroke Pines	Florida
United States	Forest Investigative Site	Philadelphia	Pennsylvania
United States	Forest Investigative Site	Riverside	California
United States	Forest Investigative Site	Sacramento	California
United States	Forest Investigative Site	Salt Lake City	Utah
United States	Forest Investigative Site	San Antonio	Texas
United States	Forest Investigative Site	San Diego	California
United States	Forest Investigative Site	Santa Monica	California
United States	Forest Investigative Site	St. Louis	Missouri
United States	Forest Investigative Site	Tacoma	Washington
United States	Forest Investigative Site	Tampa	Florida
United States	Forest Investigative Site	Tempe	Arizona
United States	Forest Investigative Site	Tulsa	Oklahoma
United States	Forest Investigative Site	Tustin	California
United States	Forest Investigative Site	Virginia Beach	Virginia
United States	Forest Investigative Site	Walnut Creek	California
United States	Forest Investigative Site	West Caldwell	New Jersey
United States	Forest Investigative Site	West Palm Beach	Florida
United States	Forest Investigative Site	Westlake Village	California
United States	Forest Investigative Site	Wichita	Kansas
United States	Forest Investigative Site	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Gedeon Richter Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean daily pain rating		Baseline to Week 14	No
Secondary	50% reduction in pain		Baseline to Week 14	No