Study of the efficacy and safety of Epalrestat to Pregabalin in patients suffering from painful diabetic peripheral neuropathy.

Phase 3

Completed

• Conditions: Health Condition 1: null- Painful diabetic peripheral neuropathy

• Registration Number: CTRI/2013/05/003646
• Lead Sponsor: Investigator Initiated study

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

1. Patients of either sex in the age group between 20 to 70 years.

2. Diabetic patients stabilized on antidiabetic medication (on stable dose of antidiabetic drugs for the last 4 weeks) with stable glycemic control (HbA1c < 9%, with ± 0.5% variation in the previous 3 months) presenting with subjective symptoms of peripheral neuropathy confirmed on the basis Modified neuropathy disability score >2.

3. Subjects whose pain score of at least 40 mm on the 100 mm visual analogue scale (VAS)

Exclusion Criteria

1. Patients with stage 3 (N3) i.e. disabling neuropathy or presence of symptoms/ signs of foot ulcer.

2. Patients with diabetic neuropathy requiring hospital admission for management of neuropathy/ diabetic complications / any other disease condition.

3. Patients presenting with primary cause of neurologic disorders other than diabetes (alcoholic neuropathy, carpal tunnel syndrome, sequelae of cerebrovascular disease).

4. Patients with history of or current diagnosis of mania, bipolar disorder, obsessive-compulsive disorder, or posttraumatic stress disorder or to be at risk of suicide judged before randomization.

5. Patients with known hypersensitivity to any of the ingredients of the test / comparator formulation.

6. Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.

7. Patients with H/O alcohol/ drug abuse.

8. Pregnant and lactating females.

9. Simultaneous participation in another clinical study or if they were receiving other experimental medications for diabetic neuropathy, prostaglandin E1 preparations, or any other medication that affects symptoms of diabetic neuropathy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified