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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00838799
First Posted: February 6, 2009
Last Update Posted: July 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Gedeon Richter Ltd.
Information provided by:
Forest Laboratories
  Purpose
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838799


  Show 54 Study Locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
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.
ClinicalTrials.gov Identifier: NCT00838799     History of Changes
Other Study ID Numbers: RG8-MD-02
First Submitted: February 5, 2009
First Posted: February 6, 2009
Last Update Posted: July 14, 2011
Last Verified: July 2011

Keywords provided by Forest Laboratories:
diabetic
peripheral
neuropathic
pain
chronic
diabetes

Additional relevant MeSH terms:
Neuralgia
Diabetic Neuropathies
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs