A clinical Trial in adult patients suffering from Neuralgia due to diabetes, chemotherapy or shingles. Clinical trial is to study efficacy, safety and tolerability of Amitriptyline 4% + Ketamine 2% Cream in comparison to Capsaicin Cream 0.025%, (reference product).

Phase 3

Completed

• Conditions: Other specified degenerative disorders of nervous system in diseases classified elsewhere,

• Registration Number: CTRI/2009/091/000688
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

This study is a single blind, placebo controlled, non-crossover, multi-centric clinical trial of Amitriptyline 4% + Ketamine 2 % Cream in adult patients having Neuralgia due to diabetes, chemotherapy or shingles that will be conducted in 2 centers of India. Test Drug or Reference Drug will be applied twice daily to the areas of worst pain for 4 weeks in 100 patients. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

 The primary outcome measures will be assessed by in adult patients suffering from Neuralgia due to diabetes, chemotherapy or shingles. At 0 Day,  Week 1, Week 2, Week 3, Week 4.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-15
• Last Update Posted: 2018-11-23

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
• Patient with history, signs & symptoms of peripheral neuropathies due to diabetes, chemotherapy or shingles.

Exclusion Criteria

• Patients < 18 & > 60 years2.
• History of hypersensitivity to the study drug or similar class of drug.3. Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications.4. Pregnant or lactating women.5. Patients with serum creatinine greater than 2.5 mg/dl.6. Patients with raised SGPT and total bilirubin greater than 50% above the upper normal limits 7.
• Significant history or presence of glaucoma, cardiovascular or hematological disease.8. Any clinical significant illness during the 4 weeks prior to day 1 of this study.9. Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease.10.
• Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study.11.
• Use of enzyme-modifying drugs within 30 days prior to day 1 of this study.12.
• HIV and Australian Antigen positive subjects.13.
• Any condition that, in the opinion of the investigator, does not justify the patients inclusion in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A comparative evaluation of efficacy of Amitriptyline 4% + Ketamine 2% Cream, with Capsaicin Cream 0.025%, in adult patients suffering from Neuralgia due to diabetes, chemotherapy or shingles.	Day 0, 1st Week, 2nd Week, 3rd Week, 4th Week.

Secondary Outcome Measures

Name	Time	Method
A comparative evaluation of safety & tolerability of Amitriptyline 4% + Ketamine 2% Cream, with Capsaicin Cream 0.025%, in adult patients suffering from Neuralgia due to diabetes, chemotherapy or shingles.	Day 0, 1st Week, 2nd Week, 3rd Week, 4th Week.

Trial Locations

Locations (4)

Dr. Patels Diabetes Speciality Centre; 🇮🇳 Latur, MAHARASHTRA, India

Life Care Clinic; 🇮🇳 Bangalore, KARNATAKA, India

Lifeline Diabetes Centre; 🇮🇳 Chennai, TAMIL NADU, India

Shree Venkatesha Hospital and Polyclinic; 🇮🇳 Thane, MAHARASHTRA, India

Dr. Patels Diabetes Speciality Centre

🇮🇳Latur, MAHARASHTRA, India

Dr Chand Patel

Principal investigator

09890345644

drchandpatel@gmail.com