NCT00044395CompletedPhase 3
LY333531 Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 200
- Locations
- 39
- Primary Endpoint
- Reduction in neuropathic symptoms
Study Overview
Brief Summary
The purpose of this protocol is to determine if an investigational drug is effective in treating nerve malfunction in diabetes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 on 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.
Outcomes
Primary Outcomes
Reduction in neuropathic symptoms
Secondary Outcomes
- 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
Investigators
Study Sites (39)
Loading locations...
Similar Trials
Completed
Phase 3
Treatment of Peripheral Neuropathy in Patients With DiabetesDiabetic NeuropathiesDiabetes MellitusNCT00044421Eli Lilly and Company400
Terminated
Phase 2
A Study to Assess the Safety and Efficacy of 7 Days Treatment With a Novel Analgesic in Subjects With Peripheral Neuropathic PainNeuralgiaNCT01485094Grünenthal GmbH114
Completed
Phase 3
Efficacy and Safety of Ralfinamide in Patients With Chronic Neuropathic Low Back PainPainNCT01019824Newron Pharmaceuticals SPA411
Completed
Not Applicable
Clinical Trial to Study a Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence Overactive Bladder (OAB)Overactive BladderNCT01125722Ethicon Endo-Surgery74
Completed
Not Applicable
Pharmacological Modulation of Peripheral Nerve ExcitabilityPeripheral NeuropathyNCT06312254Aalborg University20