Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain
A Randomized, Double-Blind, Placebo- and Active-Controlled Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain
1 other identifier
interventional
458
1 country
54
Brief Summary
This study is designed to evaluate the safety and efficacy of RGH-896 in patients with diabetic peripheral neuropathic pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 5, 2009
CompletedFirst Posted
Study publicly available on registry
February 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedJuly 14, 2011
July 1, 2011
1.2 years
February 5, 2009
July 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in mean daily pain rating
Baseline to Week 14
Secondary Outcomes (1)
50% reduction in pain
Baseline to Week 14
Study Arms (5)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
ACTIVE COMPARATOR5
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Forest Laboratorieslead
- Gedeon Richter Ltd.collaborator
Study Sites (54)
Forest Investigative Site
Birmingham, Alabama, 35242, United States
Forest Investigative Site
Mesa, Arizona, 85210, United States
Forest Investigative Site
Tempe, Arizona, 85282, United States
Forest Investigative Site
Jonesboro, Arkansas, 72401, United States
Forest Investigative Site
Little Rock, Arkansas, 72205, United States
Forest Investigative Site
North Little Rock, Arkansas, 72114, United States
Forest Investigative Site
Anaheim, California, 92801, United States
Forest Investigative Site
Burbank, California, 91505, United States
Forest Investigative Site
Lakewood, California, 90712, United States
Forest Investigative Site
National City, California, 91950, United States
Forest Investigative Site
Riverside, California, 92506, United States
Forest Investigative Site
Sacramento, California, 95821, United States
Forest Investigative Site
San Diego, California, 92117, United States
Forest Investigative Site
Santa Monica, California, 90404, United States
Forest Investigative Site
Tustin, California, 92780, United States
Forest Investigative Site
Walnut Creek, California, 94598, United States
Forest Investigative Site
Westlake Village, California, 91361, United States
Forest Investigative Site
Boulder, Colorado, 80304, United States
Forest Investigative Site
New Britain, Connecticut, 06050, United States
Forest Investigative Site
Bradenton, Florida, 34203, United States
Forest Investigative Site
Brandon, Florida, 33511, United States
Forest Investigative Site
DeLand, Florida, 32720, United States
Forest Investigative Site
Hollywood, Florida, 33023, United States
Forest Investigative Site
Jacksonville, Florida, 32216, United States
Forest Investigative Site
Miami, Florida, 33108, United States
Forest Investigative Site
Orlando, Florida, 32806, United States
Forest Investigative Site
Pembroke Pines, Florida, 33024, United States
Forest Investigative Site
Tampa, Florida, 33606, United States
Forest Investigative Site
West Palm Beach, Florida, 33401, United States
Forest Investigative Site
Honolulu, Hawaii, 96814, United States
Forest Investigative Site
Boise, Idaho, 83642, United States
Forest Investigative Site
Wichita, Kansas, 67203, United States
Forest Investigative Site
Covington, Louisiana, 70433, United States
Forest Investigative Site
Owings Mills, Maryland, 21117, United States
Forest Investigative Site
St Louis, Missouri, 63141, United States
Forest Investigative Site
West Caldwell, New Jersey, 07006, United States
Forest Investigative Site
Albuquerque, New Mexico, 87108, United States
Forest Investigative Site
New York, New York, 10004, United States
Forest Investigative Site
Charlotte, North Carolina, 28211, United States
Forest Investigative Site
Greenville, North Carolina, 27834, United States
Forest Investigative Site
Winston-Salem, North Carolina, 27103, United States
Forest Investigative Site
Cleveland, Ohio, 44122, United States
Forest Investigative Site
Kettering, Ohio, 45429, United States
Forest Investigative Site
Tulsa, Oklahoma, 74104, United States
Forest Investigative Site
Duncansville, Pennsylvania, 16635, United States
Forest Investigative Site
Philadelphia, Pennsylvania, 19139, United States
Forest Investigative Site
Columbia, South Carolina, 29201, United States
Forest Investigative Site
Memphis, Tennessee, 38119, United States
Forest Investigative Site
Dallas, Texas, 75246, United States
Forest Investigative Site
Lake Jackson, Texas, 77566, United States
Forest Investigative Site
San Antonio, Texas, 78229, United States
Forest Investigative Site
Salt Lake City, Utah, 84106, United States
Forest Investigative Site
Virginia Beach, Virginia, 23454, United States
Forest Investigative Site
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Allyson Gage, PhD
Forest Research Institute, a subsidiary of Forest Laboratories Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 5, 2009
First Posted
February 6, 2009
Study Start
February 1, 2009
Primary Completion
April 1, 2010
Last Updated
July 14, 2011
Record last verified: 2011-07