Clinical trial NCT00838799: Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Peripheral Neuropathic Pain
Keywords: diabetic
peripheral
neuropathic
pain
chronic
diabetes
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Gedeon Richter Ltd.
First posted: 2009-02-06
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change in mean daily pain rating
timeFrame: Baseline to Week 14
Secondary outcomes:
measure: 50% reduction in pain
timeFrame: Baseline to Week 14
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site
state: Alabama
city: Mesa
country: United States
facility: Forest Investigative Site
state: Arizona
city: Tempe
country: United States
facility: Forest Investigative Site
state: Arizona
city: Jonesboro
country: United States
facility: Forest Investigative Site
state: Arkansas
city: Little Rock
country: United States
facility: Forest Investigative Site
state: Arkansas
city: North Little Rock
country: United States
facility: Forest Investigative Site
state: Arkansas
city: Anaheim
country: United States
facility: Forest Investigative Site
state: California
city: Burbank
country: United States
facility: Forest Investigative Site
state: California
city: Lakewood
country: United States
facility: Forest Investigative Site
state: California
city: National City
country: United States
facility: Forest Investigative Site
state: California
city: Riverside
country: United States
facility: Forest Investigative Site
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site
state: California
city: San Diego
country: United States
facility: Forest Investigative Site
state: California
city: Santa Monica
country: United States
facility: Forest Investigative Site
state: California
city: Tustin
country: United States
facility: Forest Investigative Site
state: California
city: Walnut Creek
country: United States
facility: Forest Investigative Site
state: California
city: Westlake Village
country: United States
facility: Forest Investigative Site
state: California
city: Boulder
country: United States
facility: Forest Investigative Site
state: Colorado
city: New Britain
country: United States
facility: Forest Investigative Site
state: Connecticut
city: Bradenton
country: United States
facility: Forest Investigative Site
state: Florida
city: Brandon
country: United States
facility: Forest Investigative Site
state: Florida
city: DeLand
country: United States
facility: Forest Investigative Site
state: Florida
city: Hollywood
country: United States
facility: Forest Investigative Site
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative Site
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site
state: Florida
city: West Palm Beach
country: United States
facility: Forest Investigative Site
state: Florida
city: Honolulu
country: United States
facility: Forest Investigative Site
state: Hawaii
city: Boise
country: United States
facility: Forest Investigative Site
state: Idaho
city: Wichita
country: United States
facility: Forest Investigative Site
state: Kansas
city: Covington
country: United States
facility: Forest Investigative Site
state: Louisiana
city: Owings Mills
country: United States
facility: Forest Investigative Site
state: Maryland
city: St. Louis
country: United States
facility: Forest Investigative Site
state: Missouri
city: West Caldwell
country: United States
facility: Forest Investigative Site
state: New Jersey
city: Albuquerque
country: United States
facility: Forest Investigative Site
state: New Mexico
city: New York
country: United States
facility: Forest Investigative Site
state: New York
city: Charlotte
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Greenville
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Cleveland
country: United States
facility: Forest Investigative Site
state: Ohio
city: Kettering
country: United States
facility: Forest Investigative Site
state: Ohio
city: Tulsa
country: United States
facility: Forest Investigative Site
state: Oklahoma
city: Duncansville
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Columbia
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Memphis
country: United States
facility: Forest Investigative Site
state: Tennessee
city: Dallas
country: United States
facility: Forest Investigative Site
state: Texas
city: Lake Jackson
country: United States
facility: Forest Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Forest Investigative Site
state: Utah
city: Virginia Beach
country: United States
facility: Forest Investigative Site
state: Virginia
city: Tacoma
country: United States
facility: Forest Investigative Site
state: Washington
Study officials:
affiliation: Forest Research Institute, a subsidiary of Forest Laboratories Inc.
name: Allyson Gage, PhD
role: STUDY_DIRECTOR
References: