| CTRI Number |
CTRI/2026/03/106699 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
29/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Efficacy and Safety of Aceclofenac + Drotaverine Fixed Dose Combination Tablets in Patients with Acute Abdominal Colicky Pain |
|
Scientific Title of Study
|
Post Marketing Study of Aceclofenac + Drotaverine Tablets in the Treatment of Acute Abdominal Colicky Pain (Biliary Colic, Ureteric Colic) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Ipca/ADCP/PMS-24 Version 01 dated 30.07.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Pareek |
| Designation |
President, Medical Affairs and Clinical Research |
| Affiliation |
Ipca Laboratories Limited |
| Address |
Plot 142-AB, 2nd floor Kandivli Industrial Estate, Kandivli (West) Mumbai, Maharashtra
Mumbai (Suburban)
MAHARASHTRA
400067
India |
| Phone |
02266474641 |
| Fax |
|
| Email |
anil.pareek@ipca.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Pareek |
| Designation |
President, Medical Affairs and Clinical Research |
| Affiliation |
Ipca Laboratories Limited |
| Address |
Plot 142-AB, 2nd floor Kandivli Industrial Estate, Kandivli (West) Mumbai, Maharashtra
MAHARASHTRA
400067
India |
| Phone |
02266474641 |
| Fax |
|
| Email |
anil.pareek@ipca.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitin Chandurkar |
| Designation |
Senior Vice President, Clinical Research and Development |
| Affiliation |
Ipca Laboratories Limited |
| Address |
Plot 142-AB, 2nd floor Kandivli Industrial Estate, Kandivli (West) Mumbai, Maharashtra
Mumbai (Suburban)
MAHARASHTRA
400067
India |
| Phone |
02266474622 |
| Fax |
|
| Email |
nitin.chandurkar@ipca.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ipca Laboratories Ltd |
| Address |
125-AB, Kandivli Industrial Estate, Kandivli West, Mumbai-400067, Maharashtra |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
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 Moksha Gowda |
Citizen Hospital |
Number 14, 2nd main dispensary road, Kalasipalya
Bangalore
KARNATAKA |
9980107723
mokshagowda23@gmail.com |
| Dr Surendra Kumar Jain |
Jaipur National University Institute for Medical Sciences & Research Centre |
Near RTO Office, Jagatpura
Jaipur
RAJASTHAN |
9257036514
Drskjain.surgery@gmail.com |
| Dr Sanjeev Mohan |
M V Hospital and Research Center |
314/30, Mirza Mandi Chowk
Lucknow
UTTAR PRADESH |
9839013867
mvhrclko@gmail.com |
| Dr Mohit Khakholia |
Marwari Hospitals |
Department of Surgery, MS-Block Sati Jaymati Road, Athgaon
Kamrup
ASSAM |
7002359837
mohitkhakholia71@gmail.com |
| Dr Prashant Lad |
Om Sai Onco Surgery Multispecialty Center |
Department of Surgery, OPD section, ground floor, Kolhapur- 416006
Kolhapur
MAHARASHTRA |
8237772626
omsaicr17@gmail.com |
| Dr PV G S Prasad |
Renova Neelima Hospital |
Opposite Voltas Company, Sanathnagar
Hyderabad
TELANGANA |
9985949478
drprasadpvgs@gmail.com |
| Dr Sushil M Damor |
Rudra Multispeciality Hospital |
Department of General Surgery 1st and 2nd Floor, Narayan Resi Complex, Near Vaikunth Towership,, Gate No.02, Khodiyar, Nagar, New VIP Road, Vadodara-390018, Gujarat.
Vadodara
GUJARAT |
8511613612
sushil.damor@gmail.com |
| Dr Sameer Mulla |
SDM College of Medical Sciences and Hospital |
Deartment of Surgery, Unit 2, Room no. 1, Manjushree Nagar, Sattur 580009
Dharwad
KARNATAKA |
9986535123
dr.sameer.mulla@gmail.com |
| Dr S R Ramakrishnan |
Sri Ramchandra Hospital |
Clinical Research Division, Dental College Basement, No.1 Ramachandra Nagar, Porur
Chennai
TAMIL NADU |
9444912452
drsrk_71@yahoo.com |
| Dr Bahar Kulkarni |
Sushrut Hospital |
Department of Sugery, OPD no 1 Kothrud, Pune-411038
Pune
MAHARASHTRA |
020-35320000
drbahar.kulkarni96@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Citizen Hospital Institutional Ethics Committee |
Approved |
| ECRC HEC Marwari Hospitals |
Approved |
| Ethics Committee Sanjeevan Hospital |
Approved |
| Institutional Ethics Committee for M V Hospital and Research Center |
Approved |
| Institutional Ethics Committee JNUIMSRC |
Approved |
| Institutional Ethics Committee Neelima Hospital |
Approved |
| Institutional Ethics Committee SDM College Of Medical Sciences & Hospital |
Approved |
| Institutional Ethics Committee SRIHER |
Approved |
| Om Sai Onco Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N23||Unspecified renal colic, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aceclofenac plus Drotaverine |
Aceclofenac 100 mg plus Drotaverine 80 mg Fixed dose combination orally twice daily for five days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female patients aged 18 to 65 years (both inclusive)
2.Patients with presence and history of biliary or ureteric colic as confirmed by ultrasound
3.Patients with mild to moderate pain requiring oral therapy
4.Patients with history of at least one episode of colicky pain within 24 hours prior to screening and not requiring hospitalization
|
|
| ExclusionCriteria |
| Details |
1.Patients with presence of severe or chronic abdominal colic pain requiring parenteral treatment
2.Patients with colic pain other than biliary or ureteric colic
3.Patients with hypersensitivity to Aceclofenac, Drotaverine or to any of the excipients
4.Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticria) in response to ibuprofen, aspirin or other NSAIDs
5.Patients with active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)
6.Patients with history of gastrointestinal bleeding or perforation related to previous NSAID therapy
7.Patients with severe heart failure, hepatic failure and renal failure
8.Patients with presence/history of porphyria
9.Patients with history of active bleedings or bleeding disorders
10.Patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and or cerebrovascular disease
11.Patients with second or third degree atrioventricular block, cardiogenic shock and arterial hypotension
12.Pregnant or lactating women
13.Patients who are on any other prescription analgesics or antispasmodic medications within the previous week before study enrollment
14.Patients with presence history of cognitive impairment, alcohol abuse, psychiatric illness that would affect the ability of the patient to complete patient diary and other assessments
15.Patients with any other clinically significant illness or conditions which may interfere in the inclusion of a patient in the study as per the investigator’s opinion
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the safety, tolerability, and effectiveness of Aceclofenac (100 mg) + Drotaverine (80 mg) tablets |
Baseline, Follow Up Visit Day 3 End of the Study Visit Day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in pain intensity score |
0, 2, 4, 8, 24, 48, 72, 96, 120 hours |
| Mean change in pain relief score |
2, 4, 8, 24, 48, 72, 96, 120 hours |
| Patients and Physician global impression on study drug effectiveness |
End of Study |
| Proportion of Patients requiring rescue medication |
End of Study |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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 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
|
This open label, prospective, active post marketing surveillance
study evaluates the Fixed-Dose Combination (FDC) of Drotaverine 80 mg
and Aceclofenac 100 mg in patients with acute abdominal colic pain.
Patients will receive one tablet twice daily for 5
days. The objective of the study is to document real life safety, tolerability
and efficacy of study medication. |