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Completed

NCT Number: NCT00838799

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

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

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Key information

Conditions

Diabetic Peripheral Neuropathic Pain Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Metabolic Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Organizing Pneumonia Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Forest Investigative Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RGH-896

Drug

45 mg TID, capsules, 14 weeks.

Pregabalin

Drug

100 mg, TID, capsules, 14 weeks.

Other names: Lyrica

Placebo

Drug

TID, capsules, 14 weeks.

Primary outcomes

  1. Change in mean daily pain rating

    Time frame: Baseline to Week 14

Secondary outcomes

  1. 50% reduction in pain

    Time frame: Baseline to Week 14

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Collaborators

  • Gedeon Richter Ltd.

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
First posted
Feb 6, 2009
Registry last updated
Jul 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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