Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Non-Insulin-Dependent; Diabetes Mellitus, Insulin-Dependent; Diabetic Neuropathies

• Registration Number: NCT00044408
• Lead Sponsor: Chromaderm, Inc.

Brief Summary

The purpose of this protocol is to determine if an investigational drug known as LY333531 is effective in treating nerve malfunction in diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2002-08-28
• Study First Submitted QC: 2002-08-29
• Study First Posted: 2002-08-30
• Study Completion: 2005-10
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients must have type I or type II Diabetes Mellitus.
• Have clinically diagnosed positive sensory symptoms such as numbness, lancinating pain, burning pain, aching pain, allodynia and prickling sensation that have been present not greater than 5 years but stable for 6 months.
• Has a HbA1C less than or equal to 12%. Patients with HbA1C greater than 9% must be insulin therapy.
• Must be 18 years or older.
• Be able to visit the doctor's office approximately 3 times over a maximum of a 6-week period to determine if you can continue in the study.

Exclusion Criteria

• History of significant liver problems.
• Have poor kidney function.
• Drink an excess of alcohol or abuse drugs.
• Have recently participated or currently participating in a Medical study in which you receive an experimental drug.
• Are a woman and are pregnant or breastfeeding, intend to become pregnant within the next 2 years or a woman not using effective birth control.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in neuropathic symptoms

Secondary Outcome Measures

Name	Time	Method
Vibration sensation;Neurological signs;Electrophysiology of peroneal, tibial and sural nerves;Relief of symptoms as measured by VAS;Composite scores of nerve function;Clinical global impression of change

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇬🇧 Manchester, United Kingdom