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

Forest Laboratories

Status and phase: Completed; Phase 2

Conditions: Diabetic Peripheral Neuropathic Pain

Treatments: Drug: RGH-896; Drug: placebo; Drug: pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00838799

RG8-MD-02

Details and patient eligibility

About

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

Enrollment: 458 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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458 participants in 5 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: RGH-896

Drug: RGH-896

Drug: RGH-896

2

Experimental group

Treatment:

Drug: RGH-896

Drug: RGH-896

Drug: RGH-896

3

Experimental group

Treatment:

Drug: RGH-896

Drug: RGH-896

Drug: RGH-896

4

Active Comparator group

Treatment:

Drug: pregabalin

5

Placebo Comparator group

Treatment:

Drug: placebo