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

July 6, 2011 updated by: Forest Laboratories

A Randomized, Double-Blind, Placebo- and Active-Controlled 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

458

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35242
        • Forest Investigative Site
    • Arizona
      • Mesa, Arizona, United States, 85210
        • Forest Investigative Site
      • Tempe, Arizona, United States, 85282
        • Forest Investigative Site
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Forest Investigative Site
      • Little Rock, Arkansas, United States, 72205
        • Forest Investigative Site
      • North Little Rock, Arkansas, United States, 72114
        • Forest Investigative Site
    • California
      • Anaheim, California, United States, 92801
        • Forest Investigative Site
      • Burbank, California, United States, 91505
        • Forest Investigative Site
      • Lakewood, California, United States, 90712
        • Forest Investigative Site
      • National City, California, United States, 91950
        • Forest Investigative Site
      • Riverside, California, United States, 92506
        • Forest Investigative Site
      • Sacramento, California, United States, 95821
        • Forest Investigative Site
      • San Diego, California, United States, 92117
        • Forest Investigative Site
      • Santa Monica, California, United States, 90404
        • Forest Investigative Site
      • Tustin, California, United States, 92780
        • Forest Investigative Site
      • Walnut Creek, California, United States, 94598
        • Forest Investigative Site
      • Westlake Village, California, United States, 91361
        • Forest Investigative Site
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Forest Investigative Site
    • Connecticut
      • New Britain, Connecticut, United States, 06050
        • Forest Investigative Site
    • Florida
      • Bradenton, Florida, United States, 34203
        • Forest Investigative Site
      • Brandon, Florida, United States, 33511
        • Forest Investigative Site
      • DeLand, Florida, United States, 32720
        • Forest Investigative Site
      • Hollywood, Florida, United States, 33023
        • Forest Investigative Site
      • Jacksonville, Florida, United States, 32216
        • Forest Investigative Site
      • Miami, Florida, United States, 33108
        • Forest Investigative Site
      • Orlando, Florida, United States, 32806
        • Forest Investigative Site
      • Pembroke Pines, Florida, United States, 33024
        • Forest Investigative Site
      • Tampa, Florida, United States, 33606
        • Forest Investigative Site
      • West Palm Beach, Florida, United States, 33401
        • Forest Investigative Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Forest Investigative Site
    • Idaho
      • Boise, Idaho, United States, 83642
        • Forest Investigative Site
    • Kansas
      • Wichita, Kansas, United States, 67203
        • Forest Investigative Site
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Forest Investigative Site
    • Maryland
      • Owings Mills, Maryland, United States, 21117
        • Forest Investigative Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Forest Investigative Site
    • New Jersey
      • West Caldwell, New Jersey, United States, 07006
        • Forest Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Forest Investigative Site
    • New York
      • New York, New York, United States, 10004
        • Forest Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Forest Investigative Site
      • Greenville, North Carolina, United States, 27834
        • Forest Investigative Site
      • Winston-Salem, North Carolina, United States, 27103
        • Forest Investigative Site
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Forest Investigative Site
      • Kettering, Ohio, United States, 45429
        • Forest Investigative Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Forest Investigative Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Forest Investigative Site
      • Philadelphia, Pennsylvania, United States, 19139
        • Forest Investigative Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Forest Investigative Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Forest Investigative Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Forest Investigative Site
      • Lake Jackson, Texas, United States, 77566
        • Forest Investigative Site
      • San Antonio, Texas, United States, 78229
        • Forest Investigative Site
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Forest Investigative Site
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Forest Investigative Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Forest Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: RGH-896
45 mg TID, capsules, 14 weeks.
Drug: RGH-896
30 mg TID, capsules, 14 weeks.
Drug: RGH-896
15 mg TID, capsules, 14 weeks.
Experimental: 2
Drug: RGH-896
45 mg TID, capsules, 14 weeks.
Drug: RGH-896
30 mg TID, capsules, 14 weeks.
Drug: RGH-896
15 mg TID, capsules, 14 weeks.
Experimental: 3
Drug: RGH-896
45 mg TID, capsules, 14 weeks.
Drug: RGH-896
30 mg TID, capsules, 14 weeks.
Drug: RGH-896
15 mg TID, capsules, 14 weeks.
Active Comparator: 4
Drug: pregabalin
100 mg, TID, capsules, 14 weeks.
Other Names:
  • Lyrica
Placebo Comparator: 5
Drug: placebo
TID, capsules, 14 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in mean daily pain rating
Time Frame: Baseline to Week 14
Baseline to Week 14

Secondary Outcome Measures

Outcome Measure
Time Frame
50% reduction in pain
Time Frame: Baseline to Week 14
Baseline to Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Collaborators

Gedeon Richter Ltd.

Investigators

  • Study Director: Allyson Gage, PhD, Forest Research Institute, a subsidiary of Forest Laboratories Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

February 5, 2009

First Submitted That Met QC Criteria

February 5, 2009

First Posted (Estimate)

February 6, 2009

Study Record Updates

Last Update Posted (Estimate)

July 14, 2011

Last Update Submitted That Met QC Criteria

July 6, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG8-MD-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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