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CTRI Number  CTRI/2024/07/071354 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 22/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Phase III Study Comparing Gabapentin-Duloxetine Capsules to Pregabalin-Duloxetine Capsules for Neuropathic Pain 
Scientific Title of Study   A phase III double blind multicenter randomized prospective parallel group study to evaluate the efficacy and safety of test product fixed dose combination of Gabapentin 200 mg and Duloxetine 20 mg capsule and test product fixed dose combination of Gabapentin 300 mg and Duloxetine 30 mg capsule manufactured by Synokem Pharmaceuticals Limited New Delhi India when compared with the reference product fixed dose combination of Pregabalin 75 mg and Duloxetine 30 mg capsule in treatment of neuropathic pain  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SB-IND-CT-063 Amendment 2.0 dated 01 Nov 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neel Lahoti 
Designation  Head CRO 
Affiliation  Synergen Bio Private Limited 
Address  Synergen Bio Private Limited Unit Nos 101 to 104 Sai Chambers 302 Opp Bajaj showroom Old Mumbai Pune Highway Wakadewadi Shivajinagar Pune

Pune
MAHARASHTRA
411003
India 
Phone  9028000444  
Fax    
Email  neel@synergenbio.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neel Lahoti 
Designation  Head CRO 
Affiliation  Synergen Bio Private Limited 
Address  Synergen Bio Private Limited Unit Nos 101 to 104 Sai Chambers 302 Opp Bajaj showroom Old Mumbai Pune Highway Wakadewadi Shivajinagar Pune

Pune
MAHARASHTRA
411003
India 
Phone  9028000444  
Fax    
Email  neel@synergenbio.com  
 
Details of Contact Person
Public Query  
Name  Umakant Ghodke 
Designation  Head CT 
Affiliation  Synergen Bio Private Limited 
Address  Synergen Bio Private Limited Unit Nos 101 to 104 Sai Chambers 302 Opp Bajaj showroom Old Mumbai Pune Highway Wakadewadi Shivajinagar Pune

Pune
MAHARASHTRA
411003
India 
Phone  9960598942  
Fax    
Email  umakant.ghodke@synergenbio.com  
 
Source of Monetary or Material Support  
Synokem Pharmaceuticals Ltd 14/486 Sundar Vihar Outetestr Ring Road Paschim Vihar New Delhi 110087 
 
Primary Sponsor  
Name  Mr Surender Arora 
Address  14/486 Sundar Vihar Outetestr Ring Road Paschim Vihar New Delhi 110087 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Synokem Pharmaceuticals Ltd  Ms Synokem Pharmaceuticals Ltd Plot No 35 36 Sec 6A Integrated Industrial Estate SIDCUL Ranipur BHEL Haridwar Uttarakhand 249403  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Girish Sonwalkar   BHS Lakeview Hospital   Department of General Medicine Ground Floor Room Number 04 R.S No 72/7 CTS NO 11888 Opp Fort Lake Gandhi Nagar Belgavi 590016
Belgaum
KARNATAKA 		 9448144615

drgirishsonwalkar@gmail.com 
Dr Praveen Kumar S   PMSSY (Super Speciality Hospital)  General Medicine Department Room number 01 Victoria Hospital Campus Banglore Medical College and Research
Bangalore
KARNATAKA 		 9448685155

dmpraveen@gmail.com 
Dr Prabhat Kumar Agrawal  S N Medical College Agra  Department of Medicine first Floor Room number 20 Near Central Library Moti Katra Mantola
Agra
UTTAR PRADESH 		 9319250485

ppagrawal120@gmail.com 
Dr Shekarappa K  Subbaiah Institute of Medical Sciences   General Medicine Department Ground floor room number 06 NH 13 HH Road Purle Shivamogga Kamataka 577202
Shimoga
KARNATAKA 		 9448414763

dr.shekarappa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
ETHICS COMMITTEE OF BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE  Approved 
Ethics Committee of Subbaiah Institute of Medical Science  Submittted/Under Review 
Institutional Ethics Committee S N Medical College  Approved 
Lakeview Ethics Committee BHS Lakeview Hospital   Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G938||Other specified disorders of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fixed Dose Combination of Gabapentin + Duloxetine Capsule  Test Product (T1) Fixed Dose Combination of Gabapentin 200 mg + Duloxetine 20mg capsule frequency: Combination of gabapentin and duloxetine will be 200 mg +20mg on day 1,400+40mg on day 2 and on onwards will be continued with BD in daily divided dose. Route of Administration: Oral Duration:08 Weeks 
Intervention  Fixed Dose Combination of Gabapentin + Duloxetine capsule  Test Product (T2) Fixed Dose Combination of Gabapentin 300mg + Duloxetine 30mg capsule Frequency: Combination of gabapentin and duloxetine will be accordingly 300mg +30mg on day 1, 600mg + 60mg on day 2 and on onwards will be continued with BD Route of Administration: Oral Duration: 08 Weeks 
Comparator Agent  Fixed Dose Combination of Pregabalin + Duloxetine capsule  Reference product Fixed Dose Combination of Pregabalin 75mg + Duloxetine 30mg capsule Frequency: Combination of pregabalin and duloxetine will be BD from day 1 itself Route of Administration : Oral Duration: 08 Weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Male and Female patients with age more than 18 years.
2. Written informed consent signed by patient and willing to comply with the study procedure.
3. Patients with established newly diagnosis of Neuropathic pain (e.g., Post herpetic neuralgia, Diabetic neuropathy, post-surgical/ traumatic neuropathic pain.).
4. Presence of dynamic tactile allodynia or pinprick hyperalgesia in the area of pain.
5. Except Neuropathic pain and diseases associated with it patient is judged to be in general good health based on medical history and physical examination.
6. In case of woman of childbearing potential willing to use effective contraception during the study and willing to undergo pregnancy test
7. Patients having pain rating of at least 4 on a VAS of 0-10. 
 
ExclusionCriteria 
Details  1. Patients with age less than 18 years.
2. Pregnant and lactating women patients.
3. Women of childbearing potential who are not willing to use effective contraception during the study and not willing to undergo pregnancy test.
4. Patients not willing to comply with the study protocol and provide written informed consent to participate.
5. Participation in a clinical trial with an investigational product within 90 days preceding day one of this study.
6. Patients with known history of cardiac failure, orthostatic hypotension, narrow angle glaucoma, renal and liver impairment or any other condition that in the judgment of the investigator not suitable to be enrolled in the study.
7. Patients having history of any other type of pain as severe as the pain under study.
8. Patients having history of any other type of Neuropathic pain not included in the study.
9. Patients having skin disease, breakdown, infection, or extreme thinning at the site of pain.
10. Patients with known hypersensitivity to Amitriptyline / Lidocaine / Capsaicin.
11. Patients with history of using topically applied Amitriptyline / Lidocaine / Capsaicin and corticosteroids on the painful area.
12. Concurrent class I antiarrhythmic drugs (eg, tocainide or mexiletine)
13. Patient with known alcohol or other substance abuse as per treating physician discretion within last one year from screening or patient who consume alcohol during the surveillance, which in the opinion of the investigator will impact patient’s treatment evaluation and safety during surveillance.
14. History of HIV, HBV, HCV
15. History of any acute/chronic stokes, heart failures and relevant cardiac diseases.
16. Hypercreativity of the study drug.
17. Patients already using any other medication for pain relief like PCM/ NSAIDS /opioids etc. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean change in Pain Intensity as assessed by VAS  Baseline, Treatment Visit Week 4 and EOT or EOS Week 8 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in Allodynia (pain due to a stimulus that does not normally cause pain, e.g., stroking) as assessed by VAS.  Baseline Treatment Visit Week 4 & EOT or EOS Week 8 
Mean change in Hyperalgesia (severe pain due to a stimulus that normally causes slight pain, e.g., a pinprick) as assessed by VAS.
 		 Baseline Treatment Visit Week 4 & EOT or EOS Week 8 
Pain disability index score  Baseline Treatment Visit Week 4 & EOT or EOS Week 8 
By the type, number, frequency & proportion of patients with Adverse Event(s).  Baseline Treatment Visit Week 4 & EOT or EOS Week 8 
 
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)   12/08/2024 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   This is a prospective, randomized, Double-Blind, multi center, parallel group, Active-controlled, Phase III study to evaluate the efficacy and safety of Test Product (T1) Fixed Dose Combination of Gabapentin 200 mg + Duloxetine 20 mg capsule & Test Product (T2) Fixed Dose Combination of Gabapentin 300 mg + Duloxetine 30 mg capsule manufactured by Synokem Pharmaceuticals Ltd, New Delhi, India and Reference Product (R) Fixed Dose Combination of Pregabalin 75 mg + Duloxetine 30 mg capsule in Treatment of Neuropathic Pain.”

Study Objectives:
Primary Objective: To evaluate the efficacy of test product (T1) Fixed Dose Combination of Gabapentin 200mg + Duloxetine 20mg capsule & test product (T2) Test Product (T2) Fixed Dose Combination of Gabapentin 300mg + Duloxetine 30mg capsule and Reference Product (R) Fixed Dose Combination of Pregabalin 75mg + Duloxetine 30mg capsule in patients with painful neuropathy in terms of Visual Analogue Scale (VAS)
Secondary Objective:To evaluate the Safety of test product (T1) Fixed Dose Combination of Gabapentin 200 mg + Duloxetine 20mg capsule & Test Product (T2) Fixed Dose Combination of Gabapentin 300mg + Duloxetine 30mg capsule and Reference Product (R) Fixed Dose Combination of Pregabalin 75mg + Duloxetine 30mg capsule in patients with painful neuropathy in terms of Visual Analogue Scale (VAS).

Primary Endpoint:
1. Mean change in Pain Intensity as assessed by VAS. Time Frame: Baseline to EOT/EOS.
Secondary Endpoint:
1. Mean change in Allodynia (pain due to a stimulus that does not normally cause pain, e.g., stroking) as assessed by VAS.
2. Mean change in Hyperalgesia (severe pain due to a stimulus that normally causes slight pain, e.g., a pinprick) as assessed by VAS.
3. Pain disability index score. Time Frame: Baseline to EOT/EOS.
4. By the type, number, frequency and proportion of patients with Adverse Event(s).

Study Population: 210 patients
Study Duration: 56 Days
Number of Visit: 04
 
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