The effect of Pregabalin on Pain progressing in Painful Diabetic Neuropathy - Pregabali

• Conditions: Diabtes and its complications, painful neuropathy

• Registration Number: EUCTR2006-005630-21-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-15
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Type 1 or type 2 diabetes as defined by the World Health Organization Classification.
2. Duration of diabetes of at least 5 years.
3. The HbA1c should be <9% with <1% fluctuation of HbA1c levels over the past 6 months.
4. Age between 18 and 70 years.
5. Women of childbearing potential must be using an acceptable method of contraception to prevent pregnancy when they are enrolled in the study and must agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
6. Must be meet the specified criteria for PDN (see below) and have no risk factors for other causes for neuropathy
7. Willingness to sign the Center for Research Ethics Committee (COREC) approved informed consent form

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Nursing mothers, pregnant women (excluded by a negative pregnancy test).
2. Patients with a history of drug or alcohol dependence in the last 5 years
3. Patients with severe systemic disease other than diabetes which has as a recognized complication neuropathy or severe chronic pain
4. Patients with symptoms of neuropathic pain in the upper limbs alone
5. Significant changes in skin conditions in the areas to be tested which could alter sensation.
6. Patients currently taking medications that could affect symptoms of painful DN except acetominophen (up to 3g/d) or aspirin (up to 325 mg/d).
7. Patients experiencing an increase in pain after analgesic medication washout to levels which would, in the view of the PI, require prohibited analgesic therapy within a 6 wk period.
8. Patients whose creatinine clearance is less than 70 ml/min or have significant hepatic disease (AST, ALT, ?GT >2 times upper limit for normal). Patients with TSH outside normal limits
9. Patients with a history of previous kidney, pancreas or cardiac transplantation.
10. Serious or unstable medical or psychological state that may interfere with study participation.
11. Patients having taken other systemic investigational drugs (especially for neuropathy) or initiating a new or experimental insulin delivery device within 3 months of starting the study.
12.patients with a hypersensivity to pregabalin
13. Patients who refuse to sign the informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified