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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00307749
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : December 28, 2007
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Diabetic Polyneuropathy Drug: Placebo Drug: MCC-257 Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : March 2006
Study Completion Date : August 2007
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Secondary Outcome Measures :
  1. Nerve fiber density [ Time Frame: Day 1, Week 24 ]
  2. QST [ Time Frame: Day 1, Week 12, Week 24 ]
  3. Symptom [ Time Frame: Day 1, Week 12, Week 24 ]
  4. Clinical Global Impression [ Time Frame: Week 12, Week 24 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307749


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

ClinicalTrials.gov Identifier: NCT00307749     History of Changes
Other Study ID Numbers: MCC-257-A03
First Posted: March 28, 2006    Key Record Dates
Last Update Posted: December 28, 2007
Last Verified: December 2007

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