FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/01/062147 [Registered on: 31/01/2024] Trial Registered Prospectively
Last Modified On: 12/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Diabetic Peripheral Pain Coexisting with Vitamin B12 deficiency to treat with FDC of Pregabalin plus Methylcobalamin plus Duloxetine (Delayed Release) Capsules. 
Scientific Title of Study   A Multicentric, Randomized, Double Blind, Double Dummy, Prospective, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of FDC of Pregabalin plus Methylcobalamin plus Duloxetine (Delayed Release) Capsules Versus FDC of Pregabalin plus Methylcobalamin plus Nortriptyline Tablets in Subjects with Diabetic Peripheral Neuropathic Pain Coexisting with Vitamin B12 Deficiency. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol Id: MCR/CT/0823/04 Version No: 00 Date: 23 Aug 2023  DCGI 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaishal Shah 
Designation  Principle 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.


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 Chintan B Patel  Aatman Hospital  5, Anveshan Row House, Opp. Umiya Mata Mandir, Bopal-Ghuma Main Road, Bopal, Ahmedabad-380058
Ahmadabad
GUJARAT 		 9825182251

drchintan.cr@gmail.com 
Dr Bhushan Joshi  Arghya Neurolgy Clinic  804, 8th Floor, B building, City Vista, Fountain Road, Ashoka Nagar, Kharadi, Pune, Maharashtra.
Pune
MAHARASHTRA 		 9748656798

dr.bhushan_joshi@yahoo.co.in 
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 Mounika Anitha  King George Hospital  Andhra Medical College Maharanipeta, Visakhapatnam- 530002
Visakhapatnam
ANDHRA PRADESH 		 9293721229

drmounika04@gmail.com 
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 Jitendra Shukla  Motilal Nehru Medical College  George Town, Civil Lines, Prayagraj, Uttar Pradesh-211002.
Allahabad
UTTAR PRADESH 		 8527483335

drjeetendramln@gmail.com 
Dr Anup Bende  Neurodent Superspeciality Clinic  Shivam Complex, Shop No. 5, Ground Floor, Solapur-Pune Highway, Below Sadhana Sahakari Bank, Hadapsar, Pune, Maharashtra-411028
Pune
MAHARASHTRA 		 9045025011

dranupbende@gmail.com 
Dr Amanul Haque  Nil Ratan Sircar Medical College  138, Acharya Jagadish Chandra Bose Rd, Sealdah, Raja Bazar, Kolkata, West Bengal 700014
Kolkata
WEST BENGAL 		 9804230988

aman123301@gmail.com 
Dr Pravinchandra Nagulal Soni  Rising Medicare Hospital  Survey No. 4/1, Mundhwakhardi Rd, behind Radisson Blu, Pandhari Nagar, Kharadi, Pune Maharashtra-411014.
Pune
MAHARASHTRA 		 9822057511

drpravinsoni18@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 
Institutional Ethics Committee  Approved 
Institutional Ethics committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics committee Aatman Hospital  Approved 
Institutional Ethics Committee MLN Medical College  Approved 
Rising Medicare Hospital and Institutional Ethics Committee  Approved 
Rising Medicare Hospital and Institutional Ethics Committee  Approved 
Rising Medicare Hospital and Institutional 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: E114||Type 2 diabetes mellitus with neurological complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  FDC of Pregabalin 75 mg plus Methylcobalamin 1500 mcg plus Duloxetine DR 20 mg Capsule and Matching Placebo Tablet  One capsule and one tablet once a day orally every night at bedtime for 12 weeks. 
Intervention  FDC of Pregabalin 75 mg plus Methylcobalamin 1500 mcg plus Duloxetine DR 30 mg Capsule and Matching Placebo Tablet  One capsule and one tablet once a day orally every night at bedtime for 12 weeks. 
Comparator Agent  FDC of Pregabalin 75 mg plus Methylcobalamin 1500 mcg plus Nortriptyline 10 mg Tablet and Matching Placebo Capsule  One capsule and one tablet once a day orally every night at bedtime for 12 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Male or Female subjects between 18 to 75 years of age (both inclusive).
2. Subjects with a diagnosis of type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤12% and having pain associated with diabetic peripheral neuropathy≥ 3 months.
3. Subjects with pain intensity ≥ 4 on 0-10 points of visual analog scale (VAS).
4. Subjects with decreased vitamin B12 levels (< 200 pg/mL) at screening visit.
5. Subjects who are willing to sign written informed consent for participation in the study.
6. Subjects willing to adhere to all protocol procedures. 
 
ExclusionCriteria 
Details  1. Subjects with hypersensitivity to either of the study medications or any of the ingredients of the formulation.
2. Patients with prior therapy with Pregabalin or Duloxetine or Nortriptyline and having any other neurologic disorders unrelated to diabetic peripheral neuropathic pain were excluded.
3. Patients with clinically significant impaired hepatic function. [SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 1.5X the UNL].
4. Subject with abnormal eGFR (<60 mL/min/1.73 m2).
5. Subjects with Serum creatinine more than 1.5X the ULN.
6. Patients with any abnormality on 12 lead ECG readings and the results are deemed clinically significant by the investigator.
7. Subjects with a history of HIV, Hepatitis B & C.
8. Female patients who are pregnant or lactating or planning to become pregnant during the study period.
9. Females who are not ready to use acceptable contraceptive methods during the course of study.
10. Subjects who, in the opinion of the investigator, have a history of clinically significant cardiovascular disease (e.g. MI), subjects who are on pacemakers, central nervous system disorders (e.g. seizure, bipolar disorder, generalized anxiety disorder, untreated depression, psychosis or post-traumatic stress disorder), suicidal behavior, glaucoma, angioedema, urinary retention, thyroid disorder, uncontrolled hypertension, bleeding disorders.
11. Subjects with history of suicidal thoughts and behavior.
12. Subjects with serum sodium level <130 mmol/L at screening.
13. Subjects with uncontrolled hypertension with sitting SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg at screening.
14. Patient treated with topical or systemic pain medications within past 2 weeks prior to baseline.
15. Subjects with known alcohol or other substance abuse.
16. Subjects with a medical history of Oncological Conditions.
17. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
18. Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
19. 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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Mean change in visual analog scale (VAS) from baseline to end of the treatment. (12 weeks)  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale from baseline to end of treatment. (12 weeks).
Change in the Patient global impression of change scores (PGIC) from baseline to end of the treatment. (12 Weeks).
Change in Vitamin B12 level from baseline to end of the treatment. (12 Weeks)
Consumption of rescue medication (number of Paracetamol Tablets consumed) during the study. 		 12 weeks 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
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)   15/02/2024 
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   Neuropathic Pain (NP) is a common complication of diabetes, affecting 30-50% of patients. Management is challenging due to insufficient therapeutic options. Pregabalin is effective for NP relief, and a combination of Pregabalin or Gabapentin with TCAs or SNRIs is now recommended. Combination therapy using two drugs with different mechanisms of action is beneficial in pain medicine.
Pregabalin binds to calcium channels in the central nervous system, potentially modulating pain transmission by reducing calcium influx and inhibiting excitatory neurotransmitters.
The study involves subjects taking a combination of Pregabalin 75 mg plus Methylcobalamin 1500 mcg plus Nortriptyline 10 mg Tablet and Matching Placebo Capsule, either in the Test or Reference arm. The medication is taken orally every night before sleep. The study will last for 14 weeks, with the duration of the medication being 84 ± 2 days.
 
Close