| CTRI Number |
CTRI/2025/08/093352 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study to check if Pregabalin-Duloxetine combination is safe and effective in neuropathic pain and how it is utilized in in that condition |
|
Scientific Title of Study
|
A Retrospective, Observational, Case cohort, Multicenter Study to Assess the Safety, Effectiveness & Utilization Pattern of Pregabalin-Duloxetine FDC in Neuropathic pain (ROME Study) |
| Trial Acronym |
ROME |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TPL2502092, Version- 00, Dated- 07/03/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shailesh Darji |
| Designation |
Consultant Neurologist |
| Affiliation |
Care Neuro Clinic |
| Address |
A/2, Vijay Tower, Ankur Complex, Vijaynagar Rd, above Kalupur Commercial Bank, Naranpura, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380013
India |
| Phone |
9898185360 |
| Fax |
|
| Email |
shdneuro@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zahraan Qureshi |
| Designation |
Assistant General Manager |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
Torrent House, Off. Ashram Road, Ahmedabad - 380009, Gujarat, India
Ahmadabad
GUJARAT
380009
India |
| Phone |
7069000629 |
| Fax |
|
| Email |
zahraanqureshi@torrentpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Yakshdeep Dave |
| Designation |
Manager |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
Torrent House, Off. Ashram Road, Ahmedabad - 380009, Gujarat, India
Ahmadabad
GUJARAT
380009
India |
| Phone |
7069000425 |
| Fax |
|
| Email |
yakshdeepdave@torrentpharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Ltd.
Torrent House, Off. Ashram Road, Ahmedabad - 380009, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Ltd. |
| Address |
Torrent House, Off. Ashram Road, Ahmedabad - 380009, Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VIPUL AMIN |
KARNAVATI HOSPITAL |
2ND FLOOR, OPP. TOWN HALL NR. V.,AMBAWADI S.O AHMEDAB,-380006
Ahmadabad
GUJARAT |
9824010321
vipulamin1988@gmail.com |
| Dr K D TIBREWALA |
Pariseema Complex |
A-61.62 6TH FLOOR, AMBAWADI S.O AHMEDAB,-380006
Ahmadabad
GUJARAT |
9327007911
kdtibrewala@hotmail.com |
| Dr VIRAL D PATEL |
SHRI UMIYA HEART AND MEDICAL |
137 VARDHMAN NAGAR, KA, KALOL,-382721
Ahmadabad
GUJARAT |
9824027479
vvjv2009@yahoo.in |
| Dr S L MEHTA |
VIKAS MEDICAL HEART HOSPITAL |
SRUHURD COMPLEX 3 RD,BILASIA DASKROI,-382330
Ahmadabad
GUJARAT |
9825339666
Mahetas.l@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Sangini Ethics Committee |
Approved |
| Sangini Ethics Committee |
Approved |
| Sangini Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, (2) ICD-10 Condition: G60-G65||Polyneuropathies and other disorders of the peripheral nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients suffering from Neuropathic Pain and treated with Pregabalin-Duloxetine FDC
2. Patients followed-up for 12 weeks
3. Patients having at least 1 reported follow-up visits by 3 months following dose/therapy initiation [Baseline, Visit-1(Follow-up)].
|
|
| ExclusionCriteria |
| Details |
1. Cases with incomplete medical records |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Occurrence of AE/SAE/Discontinuation from PGB-DUL FDC therapy
2. Change in VAS score from baseline to 12th week |
Baseline and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess usage pattern of PGB-DUL FDC in management of neuropathic pain
2. To assess more than or equal to 50% improvement in pain
3. Change in CGI-I Scale from baseline to 12th week |
Baseline & 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="10000"
Sample Size from India="10000"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
Neuropathic pain (NeP) is a severe form of chronic pain resulting from lesions or diseases affecting the somatosensory nervous system. It affects 3-17% of the population and is characterized by both positive symptoms (e.g., pain, paresthesia, numbness) and negative symptoms (e.g., sensory, motor, and cognitive deficits). NeP can result from various causes, including endocrine dysfunctions, viral infections, trauma, and treatment-related effects. Despite pharmacological treatments, only 30-40% of patients experience adequate relief, and the effectiveness of these drugs may decrease over time. As a result, combination therapies, such as duloxetine and pregabalin, have been explored for better management. Studies, including large-scale trials, suggest that the combination of moderate doses of duloxetine and pregabalin may offer comparable efficacy to high-dose monotherapy. Both drugs are recommended by key medical organizations and have FDA approval for managing diabetic peripheral neuropathy (DPN). This study aims to assess the safety, effectiveness, and utilization patterns of a Pregabalin-Duloxetine fixed-dose combination (FDC) in Indian patients with neuropathic pain, collecting data from approximately 10,000 patients across the country. |