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

Phase 2

Completed

• Conditions: Diabetic Peripheral Neuropathic Pain
• Interventions: Drug: RGH-896; Drug: pregabalin; Drug: placebo

• Registration Number: NCT00838799
• Lead Sponsor: Forest Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-05
• Study First Submitted QC: 2009-02-05
• Study First Posted: 2009-02-06
• Primary Completion: 2010-04
• Status Verified: 2011-07
• Disposition First Submitted: 2011-07-06
• Disposition First Submitted QC: 2011-07-06
• Last Update Submitted: 2011-07-06
• Disposition First Posted: 2011-07-14
• Last Update Posted: 2011-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 458

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	RGH-896	-
4	pregabalin	-
5	placebo	-
2	RGH-896	-
3	RGH-896	-

Primary Outcome Measures

Name	Time	Method
Change in mean daily pain rating	Baseline to Week 14

Secondary Outcome Measures

Name	Time	Method
50% reduction in pain	Baseline to Week 14

Trial Locations

Locations (1)

Forest Investigative Site; 🇺🇸 Tacoma, Washington, United States