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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Peripheral Neuropathic Pain

In brief

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

Key facts

Study ID

NCT00838799

Run by

Forest Laboratories

People needed

458

Starts

2009-02-01

Last updated by the study team

2011-07-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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