MedDataX Logo

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

NCT ID: NCT00307749

Last Updated: 2007-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Polyneuropathy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Neuropathy Nerve Conduction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

once daily for 24 weeks

2

Group Type EXPERIMENTAL

MCC-257

Intervention Type DRUG

20mg, once daily for 24 weeks

3

Group Type EXPERIMENTAL

MCC-257

Intervention Type DRUG

40mg, once daily for 24 weeks

4

Group Type EXPERIMENTAL

MCC-257

Intervention Type DRUG

80mg, once daily for 24 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

once daily for 24 weeks

Intervention Type DRUG

MCC-257

20mg, once daily for 24 weeks

Intervention Type DRUG

MCC-257

40mg, once daily for 24 weeks

Intervention Type DRUG

MCC-257

80mg, once daily for 24 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Professor

Role: PRINCIPAL_INVESTIGATOR

Information at Mitsubishi Pharma America

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MCC-257-A03

Identifier Type: -

Identifier Source: org_study_id