| CTRI Number |
CTRI/2022/09/045408 [Registered on: 12/09/2022] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Non-randomised 3 arm study] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Clinical Study for Efficacy, Safety and Tolerability of FDC of Gabapentin 400mg and Nortriptyline HCl 10mg in Adult patients with Peripheral Neuropathy with or without association of Diabetes Mellitus. |
|
Scientific Title of Study
|
An Open Label, Randomized, 3 Arm, Multicentric, Prospective Clinical Study to assess the
Efficacy, Safety and Tolerability of Fixed Dose Combination of Gabapentin 400mg and
Nortriptyline HCl 10mg Vs Gabapentin 400mg Vs Nortriptyline HCl 10mg in Adult
patients with Peripheral Neuropathy with or without association of Diabetes Mellitus. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-CE-01-2016 Version 03 04/Oct/2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sundar Ganesh |
| Designation |
Project Manager |
| Affiliation |
iDD Research Solutions Inc |
| Address |
iDD Research Solutions Pvt. Ltd. Tek Meadows Campus, No 51, 3rd, C block, Old Mahabalipuram Rd, Sholinganallur, Chennai, Tamil Nadu
Sithaphalmandi
Chennai
TAMIL NADU
600119
India |
| Phone |
9994020228 |
| Fax |
|
| Email |
sundar.ganesh@iddresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Sharma |
| Designation |
Medical Director |
| Affiliation |
iDD Research Solutions Pvt. Ltd |
| Address |
iDD Research Solutions Pvt. Ltd. Tek Meadows Campus, No 51, 3rd, C block, Old Mahabalipuram Rd, Sholinganallur, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600119
India |
| Phone |
|
| Fax |
|
| Email |
yogesh@iddresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Vairamuthu Ammaiyappan |
| Designation |
Associate Director-Project Management |
| Affiliation |
iDD Research Solutions Pvt. Ltd |
| Address |
iDD Research Solutions Pvt. Ltd. Tek Meadows Campus, No 51, 3rd, C block, Old Mahabalipuram Rd, Sholinganallur, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600119
India |
| Phone |
|
| Fax |
|
| Email |
vairamuthu.ammaiyappan@iddresearch.com |
|
|
Source of Monetary or Material Support
|
| SunGlow Lifescience Pvt Ltd,
Plot No.6, F Block, TVD’s Srishri Flats,
United Colony 2 nd street, Medavakkam,
Chennai – 600100, India. |
|
|
Primary Sponsor
|
| Name |
Sunglow Life Science Pvt Ltd |
| Address |
SunGlow Lifescience Pvt Ltd,
Plot No.6, F Block, TVD’s Srishri Flats,
United Colony 2 nd street, Medavakkam,
Chennai – 600100, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chikkalingaiah Siddegowda |
Eesha Multispeciality Hospital |
1 & 30,Ward no 6 Dasarahalli main road, Bhuvaneshwari Nagar, Dasarahalli, Bangalore 560024
Bangalore
KARNATAKA |
9844004187
eeshaclinicalresearch@gmail.com |
| Dr K Rakesh |
Excel Hospital |
Department: Neurology
Division: Neurology
Room:103
1-5-56/29, Plot No. 29, Old Alwal, Near IG Statue,beside Bharat petroleum,
Secunderabad, Telangana 500010
Hyderabad
TELANGANA |
7731030321
doctorresearch1212@gmail.com |
| Dr Reginald Varadarajulu |
Medstar Speciality Hospital |
No.614, 17/1/3, Kodigehalli Main road, Sahakarnagar, Post Bangalore, Bengaluru Urban
Bangalore
KARNATAKA |
9880101778
medstarclinicalresearch@gmail.com |
| Dr Mukulesh Gupta |
Udyaan Healthcare |
730, Udyan-1 Eldeco, Opp. AWHO,
Near Bangla Bazar, Lucknow,
Uttar Pradesh 226002,
Lucknow
UTTAR PRADESH |
8939077019
drmukuleshgupta6@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics committee Udyaan Health Care |
Approved |
| Medstar speciality Hospital Ethics Committee |
Approved |
| Medstar speciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fixed Dose Combination of Gabapentin 400mg and Nortriptyline HCl 10mg Tablet |
1 Unit of Fixed Dose Combination of Gabapentin 400mg and Nortriptyline HCl 10mg Tablet twice daily for 24 weeks. |
| Intervention |
Gabapentin 400 mg |
1 Unit of Gabapentin 400 mg Tablet twice daily for 24 weeks |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nortriptyline HCl 10 mg |
1 Unit of Nortriptyline HCl 10 mg Tablet twice daily for 24 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Men and women of at least 18 years of age willing to give informed consent for the study.
2) Patients diagnosed with peripheral neuropathy who have abnormalities in 2 of 3 categories (signs, symptoms, and objective tests of nerve conduction studies or quantitative sensory threshold testing).
3) Patients with peripheral neuropathy associated with diabetes that is stable and controlled (HbA1C ≤ than 10 %) with no new symptoms associated with diabetes within previous 3 months.
4) Patients with at least mild painful symptoms of diabetic neuropathy for at least 1 year duration, but not longer than 10 years duration
5) Patients on pain medication (prescribed analgesics), stable for atleast 3 months before study entry or pain treatment naive.
6) Patients having Toronto Clinical Neuropathy Score (TCNS) ≥ 6 at screening/ baseline visit(Day 1/ Week 0) |
|
| ExclusionCriteria |
| Details |
1) Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control.
2) Escalating or changing pain condition within the past month as evidenced by investigator examination.
3) Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days.
4) Subject has had radiofrequency treatment of an intended target dorsal root ganglion within the past 3 months.
5) Subject currently has an active implantable device including implanted cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump.
6) Subjects currently has an active infection.
7) Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates participation in this clinical trial.
8) Subject has participated in another clinical investigation within 30 days that may confound the outcomes of the current study as determined by the investigator. |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
Primary Endpoint:
a) Change from baseline in peroneal motor nerve conduction velocity at week 0 (Visit 1) and week 24.
b) Change from baseline in patient-reported responses to Toronto Clinical Neuropathy Score (TCNS) at week 0 (Visit 2) and week 24. |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Endpoints:
a) Change from baseline in quality of life administered by SF-36 Questionnaire instrument at week 0 (Visit 2), Week 12 and week 24 (Patient global impression of quality of life assessed by the SF-36
short form)
b) Adverse events will be assessed during the entire duration of the study. Laboratory end points will be assessed prior to treatment and at the end of treatment.
ï‚· Clinical - Incidence of adverse events
ï‚· Biochemical -
o Liver function tests (Bilirubin, SGOT, SGPT, ALP)
o Renal function tests (Urea, creatinine)
o Urine Examination |
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/09/2022 |
| 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
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Peripheral Nerve Disorders (Peripheral neuropathy) Peripheral neuropathy is a common problem and for some patients, pain is a disabling component of the neuropathy. The first goal in evaluating patients with painful peripheral neuropathies is to identify the cause, with the hope of identifying treatment to reverse nerve damage. When neuropathic pain is present, it is appropriate to treat this concurrently, during the evaluation, as well as during the treatment of the neuropathy, if identified is in process. For some types of neuropathy, there are no available treatments for the underlying disorder, and therapy for neuropathic pain, if present may be the only treatment available.
INVESTIGATIONAL PRODUCT (S)
GABAPENTIN Gabapentin is an anti-epileptic medication, also called an anticonvulsant. It affects chemicals and nerves in the body that are involved in the cause of seizures and some types of pain. Gabapentin is used in adults to treat nerve pain caused by herpes virus or shingles (herpes zoster) and to treat restless legs syndrome (RLS). Gabapentin is also used to treat seizures in adults and children who are at least 3 years old.
Role of Gabapentin: The mechanism of action of gabapentin remains unknown. Evidence suggests that it is most likely to be the result of a complex synergy between increased GABA synthesis, non-NMDA receptor antagonism and binding to the a2d subunit of voltage dependent calcium channels. The latter action inhibits the release of excitatory neurotransmitters. Although it was expected to act as a GABA agonist, gabapentin does not act directly on GABA receptors, nor does it influence the reuptake of GABA. It does increase the synthesis of GABA from glutamate and enhances its release from astrocytes.
Nortriptyline is a tricyclic antidepressant. It affects chemicals in the brain that may become unbalanced. Nortriptyline is used to treat symptoms of depression.
It is believed that nortriptyline either inhibits the reuptake of the neurotransmitter serotonin at the neuronal membrane or acts at beta-adrenergic receptors. Tricyclic antidepressants do not inhibit monoamine oxidase nor do they affect dopamine reuptake. Nortriptyline is a metabolite of amitriptyline and reportedly blocks norepinephrine, serotonin uptake, sodium channels, thus reduces transmission of pain sensation. |