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

This study has been completed.
Sponsor:
Information provided by:
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00307749
First received: March 27, 2006
Last updated: December 26, 2007
Last verified: December 2007
March 27, 2006
December 26, 2007
March 2006
Not Provided
Nerve Conduction Studies [ Time Frame: Day 1, Week 24 ]
Nerve Conduction Studies
Complete list of historical versions of study NCT00307749 on ClinicalTrials.gov Archive Site
  • Nerve fiber density [ Time Frame: Day 1, Week 24 ]
  • QST [ Time Frame: Day 1, Week 12, Week 24 ]
  • Symptom [ Time Frame: Day 1, Week 12, Week 24 ]
  • Clinical Global Impression [ Time Frame: Week 12, Week 24 ]
  • Nerve fiber density
  • QST
  • Symptom
  • Clinical Global Impression
Not Provided
Not Provided
 
Safety and Efficacy of MCC-257 in the Treatment of Diabetic Polyneuropathy
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
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
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Polyneuropathy
  • Drug: Placebo
    once daily for 24 weeks
  • Drug: MCC-257
    20mg, once daily for 24 weeks
  • Drug: MCC-257
    40mg, once daily for 24 weeks
  • Drug: MCC-257
    80mg, once daily for 24 weeks
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
  • Experimental: 2
    Intervention: Drug: MCC-257
  • Experimental: 3
    Intervention: Drug: MCC-257
  • Experimental: 4
    Intervention: Drug: MCC-257
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
420
August 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00307749
MCC-257-A03
Not Provided
Not Provided
Not Provided
Not Provided
Mitsubishi Tanabe Pharma Corporation
Not Provided
Principal Investigator: Professor Information at Mitsubishi Pharma America
Mitsubishi Tanabe Pharma Corporation
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP