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

This study has been completed.
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00838799
First received: February 5, 2009
Last updated: July 6, 2011
Last verified: July 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 50% reduction in pain [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 5, 2009
Last Updated: July 6, 2011
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 23, 2014