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

Sponsor
Forest Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT00838799
Collaborator
Gedeon Richter Ltd. (Industry)
458
Enrollment
54
Locations
5
Arms
8.5
Patients Per Site

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
458 participants
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
Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Lyrica

    		•
    Placebo Comparator: 5

    Drug: placebo
    TID, capsules, 14 weeks.

    Outcome Measures

    Primary Outcome Measures

    1. Change in mean daily pain rating [Baseline to Week 14]

    Secondary Outcome Measures

    1. 50% reduction in pain [Baseline to Week 14]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    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

    Locations

    Site City State Country Postal Code
    1 Forest Investigative Site Birmingham Alabama United States 35242
    2 Forest Investigative Site Mesa Arizona United States 85210
    3 Forest Investigative Site Tempe Arizona United States 85282
    4 Forest Investigative Site Jonesboro Arkansas United States 72401
    5 Forest Investigative Site Little Rock Arkansas United States 72205
    6 Forest Investigative Site North Little Rock Arkansas United States 72114
    7 Forest Investigative Site Anaheim California United States 92801
    8 Forest Investigative Site Burbank California United States 91505
    9 Forest Investigative Site Lakewood California United States 90712
    10 Forest Investigative Site National City California United States 91950
    11 Forest Investigative Site Riverside California United States 92506
    12 Forest Investigative Site Sacramento California United States 95821
    13 Forest Investigative Site San Diego California United States 92117
    14 Forest Investigative Site Santa Monica California United States 90404
    15 Forest Investigative Site Tustin California United States 92780
    16 Forest Investigative Site Walnut Creek California United States 94598
    17 Forest Investigative Site Westlake Village California United States 91361
    18 Forest Investigative Site Boulder Colorado United States 80304
    19 Forest Investigative Site New Britain Connecticut United States 06050
    20 Forest Investigative Site Bradenton Florida United States 34203
    21 Forest Investigative Site Brandon Florida United States 33511
    22 Forest Investigative Site DeLand Florida United States 32720
    23 Forest Investigative Site Hollywood Florida United States 33023
    24 Forest Investigative Site Jacksonville Florida United States 32216
    25 Forest Investigative Site Miami Florida United States 33108
    26 Forest Investigative Site Orlando Florida United States 32806
    27 Forest Investigative Site Pembroke Pines Florida United States 33024
    28 Forest Investigative Site Tampa Florida United States 33606
    29 Forest Investigative Site West Palm Beach Florida United States 33401
    30 Forest Investigative Site Honolulu Hawaii United States 96814
    31 Forest Investigative Site Boise Idaho United States 83642
    32 Forest Investigative Site Wichita Kansas United States 67203
    33 Forest Investigative Site Covington Louisiana United States 70433
    34 Forest Investigative Site Owings Mills Maryland United States 21117
    35 Forest Investigative Site St. Louis Missouri United States 63141
    36 Forest Investigative Site West Caldwell New Jersey United States 07006
    37 Forest Investigative Site Albuquerque New Mexico United States 87108
    38 Forest Investigative Site New York New York United States 10004
    39 Forest Investigative Site Charlotte North Carolina United States 28211
    40 Forest Investigative Site Greenville North Carolina United States 27834
    41 Forest Investigative Site Winston-Salem North Carolina United States 27103
    42 Forest Investigative Site Cleveland Ohio United States 44122
    43 Forest Investigative Site Kettering Ohio United States 45429
    44 Forest Investigative Site Tulsa Oklahoma United States 74104
    45 Forest Investigative Site Duncansville Pennsylvania United States 16635
    46 Forest Investigative Site Philadelphia Pennsylvania United States 19139
    47 Forest Investigative Site Columbia South Carolina United States 29201
    48 Forest Investigative Site Memphis Tennessee United States 38119
    49 Forest Investigative Site Dallas Texas United States 75246
    50 Forest Investigative Site Lake Jackson Texas United States 77566
    51 Forest Investigative Site San Antonio Texas United States 78229
    52 Forest Investigative Site Salt Lake City Utah United States 84106
    53 Forest Investigative Site Virginia Beach Virginia United States 23454
    54 Forest Investigative Site Tacoma Washington United States 98405

    Sponsors and Collaborators

    • Forest Laboratories
    • Gedeon Richter Ltd.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00838799
    Other Study ID Numbers:
    • RG8-MD-02
    First Posted:
    Feb 6, 2009
    Last Update Posted:
    Jul 14, 2011
    Last Verified:
    Jul 1, 2011
    Keywords provided by , ,
    diabetic
    peripheral
    neuropathic
    pain
    chronic
    diabetes
    Additional relevant MeSH terms:
    Neuralgia
    Diabetic Neuropathies
    Pregabalin

    Study Results

    No Results Posted as of Jul 14, 2011