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

Sponsored by:	Mitsubishi Tanabe Pharma Corporation
Information provided by:	Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:	NCT00307749

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
1: Placebo Comparator	Drug: Placebo once daily for 24 weeks
2: Experimental	Drug: MCC-257 20mg, once daily for 24 weeks
3: Experimental	Drug: MCC-257 40mg, once daily for 24 weeks
4: Experimental	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

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

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

Neuropathy
Nerve Conduction

Study placed in the following topic categories:

Signs and Symptoms
Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus

Polyneuropathies
Endocrine System Diseases
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Nervous System Diseases

Diabetes Mellitus
Polyneuropathies
Endocrine System Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on September 11, 2009