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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
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetic Polyneuropathy
 Drug: Placebo
Drug: MCC-257
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Nerve Conduction Studies [ Time Frame: Day 1, Week 24 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 420
Study Start Date: March 2006
Study Completion Date: August 2007
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
once daily for 24 weeks
Experimental: 2 Drug: MCC-257
20mg, once daily for 24 weeks
Experimental: 3 Drug: MCC-257
40mg, once daily for 24 weeks
Experimental: 4 Drug: MCC-257
80mg, once daily for 24 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307749

Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Principal Investigator: Professor Information at Mitsubishi Pharma America
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00307749     History of Changes
Other Study ID Numbers: MCC-257-A03
Study First Received: March 27, 2006
Last Updated: December 26, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Neuropathy
Nerve Conduction

Additional relevant MeSH terms:
Polyneuropathies
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013