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Safety and Efficacy of MCC-257 in the Treatment of Diabetic Polyneuropathy

Primary Purpose

Diabetic Polyneuropathy

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo
MCC-257
MCC-257
MCC-257
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Polyneuropathy focused on measuring Neuropathy, Nerve Conduction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The patient is male or female, 18-70 years of age The patient has either type 1 or type 2 diabetes The patient has mild to moderate diabetic neuropathy The patient is free from other clinically significant illness or disease, as determined by medical history, physical examination, laboratory evaluations, and other safety tests Exclusion Criteria: Being treated with anticoagulants other than aspirin, such as warfarin, digoxin, Plavix BMI>40 A significant disorder or a condition other than diabetes that can cause symptoms or physical conditions that mimic peripheral neuropathy or interfere with cognition Any proximal neuropathy, clinically evident nerve entrapment, or any focal trauma potentially affecting nerve function Women of childbearing potential who do not refrain from sexual activity or use adequate contraception Pregnant or lactating women An ALT or AST value >2X upper limit of normal (ULN) Clinically significant cardiovascular disease within the last six (6) months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    1

    2

    3

    4

    Arm Description

    Outcomes

    Primary Outcome Measures

    Nerve Conduction Studies

    Secondary Outcome Measures

    Nerve fiber density
    QST
    Symptom
    Clinical Global Impression

    Full Information

    First Posted
    March 27, 2006
    Last Updated
    December 26, 2007
    Sponsor
    Mitsubishi Tanabe Pharma Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00307749
    Brief Title
    Safety and Efficacy of MCC-257 in the Treatment of Diabetic Polyneuropathy
    Official Title
    A Phase II, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Finding Study to Evaluate the Efficacy and Safety of 20mg, 40mg and 80mg of MCC-257 in Patients With Mild to Moderate Diabetic Polyneuropathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Mitsubishi Tanabe Pharma Corporation

    4. Oversight

    5. Study Description

    Brief Summary
    The primary objectives of the study are to evaluate the efficacy and safety of three doses of MCC-257 in patients with mild to moderate diabetic polyneuropathy
    Detailed Description
    The study will use a double-blind, randomized, placebo-controlled, fixed-dose, parallel-group design. Patients will be randomized equally to 1 of 4 treatment groups: MCC-257 20 mg, MCC-257 40 mg, MCC-257 80 mg, or placebo, given once daily for 24 weeks. The study will consist of 2 periods: 1) a screening period of up to 21 days prior to baseline, including a formal screening visit; and 2) a 24-week treatment period, during which patients will take the study treatment, and have various assessments performed during 4 visits.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Polyneuropathy
    Keywords
    Neuropathy, Nerve Conduction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    420 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Placebo Comparator
    Arm Title
    2
    Arm Type
    Experimental
    Arm Title
    3
    Arm Type
    Experimental
    Arm Title
    4
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    once daily for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    MCC-257
    Intervention Description
    20mg, once daily for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    MCC-257
    Intervention Description
    40mg, once daily for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    MCC-257
    Intervention Description
    80mg, once daily for 24 weeks
    Primary Outcome Measure Information:
    Title
    Nerve Conduction Studies
    Time Frame
    Day 1, Week 24
    Secondary Outcome Measure Information:
    Title
    Nerve fiber density
    Time Frame
    Day 1, Week 24
    Title
    QST
    Time Frame
    Day 1, Week 12, Week 24
    Title
    Symptom
    Time Frame
    Day 1, Week 12, Week 24
    Title
    Clinical Global Impression
    Time Frame
    Week 12, Week 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patient is male or female, 18-70 years of age The patient has either type 1 or type 2 diabetes The patient has mild to moderate diabetic neuropathy The patient is free from other clinically significant illness or disease, as determined by medical history, physical examination, laboratory evaluations, and other safety tests Exclusion Criteria: Being treated with anticoagulants other than aspirin, such as warfarin, digoxin, Plavix BMI>40 A significant disorder or a condition other than diabetes that can cause symptoms or physical conditions that mimic peripheral neuropathy or interfere with cognition Any proximal neuropathy, clinically evident nerve entrapment, or any focal trauma potentially affecting nerve function Women of childbearing potential who do not refrain from sexual activity or use adequate contraception Pregnant or lactating women An ALT or AST value >2X upper limit of normal (ULN) Clinically significant cardiovascular disease within the last six (6) months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Professor
    Organizational Affiliation
    Information at Mitsubishi Pharma America
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy of MCC-257 in the Treatment of Diabetic Polyneuropathy

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