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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Collaborator: Gedeon Richter Ltd.
• Treatments: Pregabalin

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