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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00307749
MCC-257-A03
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