| CTRI Number |
CTRI/2009/091/000688 [Registered on: 05/10/2009] |
| Last Modified On: |
23/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
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). |
Scientific Title of Study
Modification(s)
|
A comparative single blind, Parallel group, non-crossover, multi-centric clinical trial of Amitriptyline 4% + Ketamine 2 % Cream in patients having Neuralgia due to diabetes, chemotherapy or shingles. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| APL/RC/AKC/02 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
98, Govt. Industrial Area,
Charkop, Kandivli (W)
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
98, Govt. Industrial Area,
Charkop, Kandivli (W)
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
98, Govt. Industrial Area,
Charkop, Kandivli (W)
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Ajanta Pharma Ltd |
| Address |
98, Govt. Industrial Area, Charkop, Kandivli (W)
Mumbai
MAHARASHTRA
400 067
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chand Patel |
Dr. Patels Diabetes Speciality Centre |
4, Wardhaman Complex, Opp. Sahu College.
Latur
MAHARASHTRA |
09890345644
drchandpatel@gmail.com |
| Dr. L Sreenivasa Murthy |
Life Care Clinic |
2253 MCN Complex,Kodigehalli Main Road, Sahakarnagar-560 092
Bangalore
KARNATAKA |
0 9448 051046
lifecareclinic@rediffmail.com |
| Dr I Periyandavar |
Lifeline Diabetes Centre |
59/9A,Lattice BridgeRoad,,Ist Floor,Mosque Complex,Adyar, 600 020
Chennai
TAMIL NADU |
044-65372767
meku67@yahoo.co.in |
| Dr Suhas Rao |
Shree Venkatesha Hospital and Polyclinic |
A Wing, First Floor,,Bably Apartment, Station Road, Nallasopara (West)
Thane
MAHARASHTRA |
09821881087
drcrholambe@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Jagruti Independent Ethics Committee Bandra Mumbai 400 050 |
Approved |
| Jagruti Independent Ethics Committee Bandra Mumbai 400 050 |
Approved |
| Life Care EC,2253, M.C.M, Complex, Kodigehalli Main Road, Sahakaranagar, Banglore |
Approved |
| Lifeline Diabetes Centre, 54/9-A, Lattice Bridge Road, Adyar, Chennai |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Neuralgia due to diabetes, chemotherapy or shingles, (1) ICD-10 Condition: G328||Other specified degenerative disorders of nervous system in diseases classified elsewhere, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Amitriptyline 4% + Ketamine 2% Cream |
twice daily to the areas of worst pain for 4 weeks |
| Comparator Agent |
Capsaicin Cream 0.025% |
twice daily to the areas of worst pain for 4 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
2. Patient with history, signs & symptoms of peripheral neuropathies due to diabetes, chemotherapy or shingles.
|
|
| ExclusionCriteria |
| Details |
1. Patients < 18 & > 60 years
2. 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.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pharmacy-controlled Randomization |
Blinding/Masking
Modification(s)
|
Participant Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 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
Modification(s)
|
| Outcome |
TimePoints |
| 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. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
15/10/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="2"
Days="21" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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.
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.
|