A COMPARATIVE STUDY TO EVALUATE EFFICACY AND SAFETY BETWEEN GABAPENTIN, PREGABALIN AND DULOXETINE IN PATIENTS WITH PAINFUL DIABETIC PERIPHERAL NEUROPATHY
Phase 4
Completed
- Conditions
- Health Condition 1: null- Peripheral diabetic neuropathy
- Registration Number
- CTRI/2009/091/001058
- Lead Sponsor
- Research society for the study of diabetes in India RSSDI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 152
Inclusion Criteria
Either gender with type 2 diabetes b/w 5-10 yrs duration
Patients with distal polyneuropathy by history, examination, biothesiometry & Michigan Neuropathy Screening Instrument (MNSI)
Diabetic neuropathy (DN) for at least 3 months
Patients above 18 and below 65 years
HbA1C < 10
Minimum VAS score for pain of 40 mm
Patients with written informed consent
Exclusion Criteria
Contraindications for the use of study drugs.
Hepatic, cardiac or renal failure
Patients with neuropathy due to other causes.
Patients who have undergone amputations of even one lower limb.
Pregnant and lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy measure: <br/ ><br>Reduction in pain scores at the end of 12 weeks from base line using VAS(100mm). <br/ ><br>Timepoint: 0,4,8,12 weeks
- Secondary Outcome Measures
Name Time Method Secondary efficacy measures: <br/ ><br>Sleep interference: 10 point scale (0-10). <br/ ><br>Patient Global Impression of Change (PGIC)(0-7) <br/ ><br>Clinician?s Global Impression of Change (CGIC)(0-7) <br/ ><br>Timepoint: 0,4,8,12 weeks