FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/01/062148 [Registered on: 31/01/2024] Trial Registered Prospectively
Last Modified On: 21/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Clinical study to treat patients with peripheral neuropathic pain with coexistent Vitamin B12 deficiency with the help of FDC of Gabapentin SR plus Methylcobalamin plus Nortriptyline film-coated bilayered tablets. 
Scientific Title of Study   A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Gabapentin SR plus Methylcobalamin plus Nortriptyline film-coated bilayered tablets Versus FDC of Gabapentin SR Plus Methylcobalamin film-coated tablets in patients with peripheral neuropathic pain with coexistent Vitamin B12 deficiency. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol Id: MCR/CT/0923/01 Version No: 00 Date: 08 Sep 2023  DCGI 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaishal Shah 
Designation  Principal Investigator 
Affiliation  Lifeline Hospital 
Address  Vishal Complex, S.V.Road, Opp. N.L. High School, Malad (West),Mumbai – 400064.

Mumbai
MAHARASHTRA
400064
India 
Phone  9833803296  
Fax    
Email  leo.spacewalker@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravindra Mote 
Designation  Director 
Affiliation  Mediclin Clinical Research 
Address  2nd Floor, A Wing, Ritu Horizon, Next to Ankur School, Kanakiya Road, Mira Road (E),Thane- 401107.

Thane
MAHARASHTRA
401107
India 
Phone  8888884024  
Fax    
Email  ravindra.mote@mediclincr.com  
 
Details of Contact Person
Public Query  
Name  Dr Ravindra Mote 
Designation  Director 
Affiliation  Mediclin Clinical Research 
Address  2nd Floor, A Wing, Ritu Horizon, Next to Ankur School, Kanakiya Road, Mira Road (E),Thane- 401107.

Thane
MAHARASHTRA
401107
India 
Phone  8888884024  
Fax    
Email  ravindra.mote@mediclincr.com  
 
Source of Monetary or Material Support  
Ravenbhel Healthcare Pvt. Ltd. 
 
Primary Sponsor  
Name  Ravenbhel Healthcare Pvt. Ltd. 
Address  16-17, EPIP, SIDCO, Kartholi, Bari Brahamana, Samba- 181133, Jammu and Kashmir,India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Diptak Bhowmick  College of Medicine and Sagore Dutta Hospital  Office of Principal, 578 B.T. Road, Kamarhati, Kolkata, West Bengal-700058.
Kolkata
WEST BENGAL 		 8777047635

diptak86@gmail.com 
Dr Utsa Basu  Dr. Utsa Basu’s Clinic  65-A, Middle Row, Philips More, Near Entally Tarun Sangha Club, Kolkata-700014.
Kolkata
WEST BENGAL 		 9432658968

dr.utsabasu@yahoo.com 
Dr Dnyaneshwar Halnor  Family Care Hospital  Golden Nest, Phase-1 Rd, Near Seven Square Academy, Golden Nest, Queens Park, Mira Road East, Maharashtra-401107.
Thane
MAHARASHTRA 		 7507779219

drdnyaneshwarhalnorvvh@gmail.com 
Dr K Sunil Naik  Government Medical College and Govt. General Hospital (Old RIMSGGH)  Srikakulam-532001, Andhra Pradesh, India
Srikakulam
ANDHRA PRADESH 		 9912320517

drsunilnaikggh@gmail.com 
Dr Richa Giri  GSVM Medical College  Department of Medicine, Swaroop Nagar, Kanpur-208002, UP, India.
Kanpur Nagar
UTTAR PRADESH 		 8400331045

krricha227@gmail.com 
Dr Dilip Shah  Kkasturi Medicare Pvt. Ltd.  Harsh Niketan, Gaondevi Road, Behind Navrang Hotel, Bhayandar West, Maharashtra-401101.
Thane
MAHARASHTRA 		 9820324286

drshahdilip@yahoo.co.in 
Dr Vaishal Shah  Lifeline Hospital  Vishal Complex, S V Road,Opp. N.L. High School,Malad (West), Mumbai–400 064.
Mumbai
MAHARASHTRA 		 9833803296

leo.spacewalker@gmail.com 
Dr Ashish Gautam  Sarojini Naidu Medical College  Moti Katra, Mantola, Agra, Uttar Pradesh-282003, India.
Agra
UTTAR PRADESH 		 9927089665

dr_ashishgautam@yahoo.co.in 
Dr Ketan Mehta  Suchak Hospital  186, 1st Floor, Manchubhai Road, Malad East, Maharashtra-400097.
Mumbai
MAHARASHTRA 		 9082805199

drketanmehta1717@gmail.com 
Dr Sameer Agarwal  Tulsi Hospital India Ltd.  14/116-A, Civil Lines, Kanpur-208001.
Kanpur Nagar
UTTAR PRADESH 		 8175910410

agarwalsameer66@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
College of Medicine and Sagore Dutta Hospital  Approved 
Ethics Committee  Approved 
Hurip Independent Bioethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee S.N. Medical  Approved 
Shah Lifeline Hospital And Heart Institute Ethics Committee  Approved 
Shah Lifeline Hospital And Heart Institute Ethics Committee  Approved 
Shah Lifeline Hospital And Heart Institute Ethics Committee  Approved 
Shah Lifeline Hospital And Heart Institute Ethics Committee  Approved 
Tulsi Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G63||Polyneuropathy in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  FDC of Gabapentin SR 300 mg + Methylcobalamin 1500 mcg + Nortriptyline 10 mg film-coated bilayered tablets  One tablet every night before sleep for 56 days. 
Intervention  FDC of Gabapentin SR 600 mg + Methylcobalamin 1500 mcg + Nortriptyline 10 mg film-coated bilayered tablets  One tablet every night before sleep for 56 days. 
Comparator Agent  FDC of Gabapentin SR 600 mg + Methylcobalamin 1500 mcg film-coated tablets  One tablet every night before sleep for 56 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  The study aims to evaluate patients aged 18-75 with neuropathic pain, Gabapentin and Methylcobalamin treatment, decreased Vitamin B12 levels, and non-specific symptoms like allodynia, burning, shooting, or hyperalgesia.
Participants must sign an informed consent document and adhere to all protocol procedures. 
 
ExclusionCriteria 
Details  Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
Patients using gabapentin for any other neurologic disorders unrelated to peripheral neuropathic pain.
Patient taking any other medication for the treatment of peripheral neuropathic pain last two weeks.
Patients with a diagnosis of type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) >11%.
Patients with abnormal eGFR (<60 mL/min/1.73 m2).
Patients with clinically significant impaired hepatic function. [SGOT & SGPT more than 2.5X the UNL and/or Total bilirubin more than 1.5X the UNL].
Any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patient’s participation in the study.
Ongoing administration of Monoamine Oxidase (MAO) inhibitors.
Patients with medical history of Oncological Conditions.
Patients who, in the opinion of the investigator, have history of clinically significant cardiovascular disease (e.g. MI), central nervous system disorders (e.g. seizure, bipolar disorder, generalized anxiety disorder, untreated depression, psychosis or post-traumatic stress disorder), suicidal behavior, angle closure glaucoma, angioedema, urinary retention, thyroid disorder, uncontrolled hypertension.
Patients with known cases of HIV, Hepatitis B & C.
Participant has a clinically significant disorder that, in the opinion of the investigator, would result in the participant’s inability to understand and comply with the requirements of the study.
Female subjects of childbearing potential not be willing to use an acceptable method of contraception.
Pregnant woman or lactating mother.
Patients participated in any type of clinical study within the last 3 months of the screening date.
Patients with known alcohol abuse within last one year and dependency on narcotics, opioids, or any other addictive substances.
Patients with an inability to comply with the protocol requirements. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in Pain Intensity Numerical Rating Scale (PI-NRS) from baseline to end of the study (8 weeks).  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in the Vitamin B12 levels from baseline to end of the study (8 weeks).
Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale from baseline to end of the study (8 weeks). 		 8 weeks 
 
Target Sample Size   Total Sample Size="207"
Sample Size from India="207" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Combining Pregabalin or Gabapentin with TCAs or SNRIs is a treatment option for patients who cannot tolerate high-dose monotherapy. This approach is beneficial as many patients have insufficient pain relief on monotherapy with current drugs, which often have severe side effects and tolerability issues. Lower-dose combination therapies with different mechanisms of action, such as a moderate dose of a drug reducing calcium influx and a low dose of a drug inhibiting the tricyclic antidepressant, can be beneficial in pain medicine. Nortriptyline, a major metabolite of Amitriptyline, is less sedating and better tolerated than Amitriptyline, and can improve nephropathic pain. The study involves combination of Gabapentin SR 300/600 mg + Methylcobalamin 1500/1500 mcg + Nortriptyline 10/10 mg film-coated bilayered tablets or FDC of Gabapentin SR 600 mg + Methylcobalamin 1500 mcg + Nortriptyline 10 mg film coated bilayered tablets or FDC of Gabapentin SR 600 mg + Methylcobalamin 1500 mcg film coated Tablets. The medication is taken orally One tablet every night before sleep for 56 days. The duration of study will last for 8 weeks with study timeline 56±2 days. 
Close