Status:
COMPLETED
Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain
Lead Sponsor:
Forest Laboratories
Collaborating Sponsors:
Gedeon Richter Ltd.
Conditions:
Diabetic Peripheral Neuropathic Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT00838799
Start Date
February 1 2009
Last Update
July 14 2011
Active Locations (54)
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1
Forest Investigative Site
Birmingham, Alabama, United States, 35242
2
Forest Investigative Site
Mesa, Arizona, United States, 85210
3
Forest Investigative Site
Tempe, Arizona, United States, 85282
4
Forest Investigative Site
Jonesboro, Arkansas, United States, 72401