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

This study has been completed.
Gedeon Richter Ltd.
Information provided by:
Forest Laboratories Identifier:
First received: February 5, 2009
Last updated: July 6, 2011
Last verified: July 2011
This study is designed to evaluate the safety and efficacy of RGH-896 in patients with diabetic peripheral neuropathic pain.

Condition Intervention Phase
Diabetic Peripheral Neuropathic Pain Drug: RGH-896 Drug: pregabalin Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Change in mean daily pain rating [ Time Frame: Baseline to Week 14 ]

Secondary Outcome Measures:
  • 50% reduction in pain [ Time Frame: Baseline to Week 14 ]

Enrollment: 458
Study Start Date: February 2009
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RGH-896
45 mg TID, capsules, 14 weeks.
Experimental: 2 Drug: RGH-896
30 mg TID, capsules, 14 weeks.
Experimental: 3 Drug: RGH-896
15 mg TID, capsules, 14 weeks.
Active Comparator: 4 Drug: pregabalin
100 mg, TID, capsules, 14 weeks.
Other Name: Lyrica
Placebo Comparator: 5 Drug: placebo
TID, capsules, 14 weeks.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00838799

  Show 54 Study Locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Study Director: Allyson Gage, PhD Forest Research Institute, a subsidiary of Forest Laboratories Inc.
  More Information

Responsible Party: James Perhach, Ph.D., Executive Director, Clinical Development, Forest Research Institute, a subsidiary of Forest Laboratories, Inc. Identifier: NCT00838799     History of Changes
Other Study ID Numbers: RG8-MD-02
Study First Received: February 5, 2009
Last Updated: July 6, 2011

Keywords provided by Forest Laboratories:

Additional relevant MeSH terms:
Diabetic Neuropathies
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs processed this record on September 21, 2017