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

A Randomized, Double-Blind, Placebo- and Active-Controlled Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00838799

Enrollment

458

Registered

2009-02-06

Start date

2009-02-28

Completion date

Unknown

Last updated

2011-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Peripheral Neuropathic Pain

Keywords

diabetic, peripheral, neuropathic, pain, chronic, diabetes

Brief summary

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

Interventions

DRUGRGH-896

45 mg TID, capsules, 14 weeks.

DRUGpregabalin

100 mg, TID, capsules, 14 weeks.

DRUGplacebo

TID, capsules, 14 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Change in mean daily pain rating	Baseline to Week 14

Secondary

Measure	Time frame
50% reduction in pain	Baseline to Week 14

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026