Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain
NCT ID: NCT00838799
Last Updated: 2011-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
458 participants
INTERVENTIONAL
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
RGH-896
45 mg TID, capsules, 14 weeks.
2
RGH-896
30 mg TID, capsules, 14 weeks.
3
RGH-896
15 mg TID, capsules, 14 weeks.
4
pregabalin
100 mg, TID, capsules, 14 weeks.
5
placebo
TID, capsules, 14 weeks.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Past use of pregabalin
* History of severe psychiatric disorder
* History of any amputation due to diabetes
* History of seizure disorder
* Active diabetic foot ulcers
18 Years
75 Years
ALL
No
Sponsors
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Gedeon Richter Ltd.
INDUSTRY
Forest Laboratories
INDUSTRY
Responsible Party
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Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Principal Investigators
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Allyson Gage, PhD
Role: STUDY_DIRECTOR
Forest Research Institute, a subsidiary of Forest Laboratories Inc.
Locations
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Forest Investigative Site
Birmingham, Alabama, United States
Forest Investigative Site
Mesa, Arizona, United States
Forest Investigative Site
Tempe, Arizona, United States
Forest Investigative Site
Jonesboro, Arkansas, United States
Forest Investigative Site
Little Rock, Arkansas, United States
Forest Investigative Site
North Little Rock, Arkansas, United States
Forest Investigative Site
Anaheim, California, United States
Forest Investigative Site
Burbank, California, United States
Forest Investigative Site
Lakewood, California, United States
Forest Investigative Site
National City, California, United States
Forest Investigative Site
Riverside, California, United States
Forest Investigative Site
Sacramento, California, United States
Forest Investigative Site
San Diego, California, United States
Forest Investigative Site
Santa Monica, California, United States
Forest Investigative Site
Tustin, California, United States
Forest Investigative Site
Walnut Creek, California, United States
Forest Investigative Site
Westlake Village, California, United States
Forest Investigative Site
Boulder, Colorado, United States
Forest Investigative Site
New Britain, Connecticut, United States
Forest Investigative Site
Bradenton, Florida, United States
Forest Investigative Site
Brandon, Florida, United States
Forest Investigative Site
DeLand, Florida, United States
Forest Investigative Site
Hollywood, Florida, United States
Forest Investigative Site
Jacksonville, Florida, United States
Forest Investigative Site
Miami, Florida, United States
Forest Investigative Site
Orlando, Florida, United States
Forest Investigative Site
Pembroke Pines, Florida, United States
Forest Investigative Site
Tampa, Florida, United States
Forest Investigative Site
West Palm Beach, Florida, United States
Forest Investigative Site
Honolulu, Hawaii, United States
Forest Investigative Site
Boise, Idaho, United States
Forest Investigative Site
Wichita, Kansas, United States
Forest Investigative Site
Covington, Louisiana, United States
Forest Investigative Site
Owings Mills, Maryland, United States
Forest Investigative Site
St Louis, Missouri, United States
Forest Investigative Site
West Caldwell, New Jersey, United States
Forest Investigative Site
Albuquerque, New Mexico, United States
Forest Investigative Site
New York, New York, United States
Forest Investigative Site
Charlotte, North Carolina, United States
Forest Investigative Site
Greenville, North Carolina, United States
Forest Investigative Site
Winston-Salem, North Carolina, United States
Forest Investigative Site
Cleveland, Ohio, United States
Forest Investigative Site
Kettering, Ohio, United States
Forest Investigative Site
Tulsa, Oklahoma, United States
Forest Investigative Site
Duncansville, Pennsylvania, United States
Forest Investigative Site
Philadelphia, Pennsylvania, United States
Forest Investigative Site
Columbia, South Carolina, United States
Forest Investigative Site
Memphis, Tennessee, United States
Forest Investigative Site
Dallas, Texas, United States
Forest Investigative Site
Lake Jackson, Texas, United States
Forest Investigative Site
San Antonio, Texas, United States
Forest Investigative Site
Salt Lake City, Utah, United States
Forest Investigative Site
Virginia Beach, Virginia, United States
Forest Investigative Site
Tacoma, Washington, United States
Countries
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Other Identifiers
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RG8-MD-02
Identifier Type: -
Identifier Source: org_study_id
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