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CTRI Number  CTRI/2023/04/051516 [Registered on: 12/04/2023] Trial Registered Prospectively
Last Modified On: 11/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Study to Evaluate Efficacy and Safety of fixed dose of Acotiamide plus Pantoprazole Capsule Compared to Pantoprazole tablet in patients with Acid reflux and Functional Dyspepsia. 
Scientific Title of Study   A Phase III, Randomized, Multi-centric, Double-blind, Double-dummy, Parallel-group, Prospective Study to Evaluate Efficacy and Safety of FDC of Acotiamide (As ER) 300 mg plus Pantoprazole 40 mg Capsule Compared to Monotherapy of Pantoprazole 40 mg tablet in patients with Refractory Gastroesophageal Reflux Disease (GERD) and Functional Dyspepsia 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
BRPL/CT/FDC/ACPP/02/21; Version 3.0; Date 07.11.2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aditi Datta 
Designation  Managing Director 
Affiliation  Biosite Research Private Limited 
Address  81-84, 2nd & 3rd Floor, Chandru Complex, 18th Main, RBI Layout, JP Nagar Phase 7, Bangalore, KARNATAKA-560078, India. Bangalore KARNATAKA 560078 India

Bangalore
KARNATAKA
560078
India 
Phone  91-80-35104561   
Fax    
Email  aditi.datta@biositeindia.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aditi Datta 
Designation  Managing Director 
Affiliation  Biosite Research Private Limited 
Address  81-84, 2nd & 3rd Floor, Chandru Complex, 18th Main, RBI Layout, JP Nagar Phase 7, Bangalore, KARNATAKA-560078, India. Bangalore KARNATAKA 560078 India

Bangalore
KARNATAKA
560078
India 
Phone  91-80-35104561   
Fax    
Email  aditi.datta@biositeindia.com  
 
Details of Contact Person
Public Query  
Name  Dr Aditi Datta 
Designation  Managing Director 
Affiliation  Biosite Research Private Limited 
Address  81-84, 2nd & 3rd Floor, Chandru Complex, 18th Main, RBI Layout, JP Nagar Phase 7, Bangalore, KARNATAKA-560078, India. Bangalore KARNATAKA 560078 India

Bangalore
KARNATAKA
560078
India 
Phone  91-80-35104561   
Fax    
Email  aditi.datta@biositeindia.com  
 
Source of Monetary or Material Support  
AKUMS DRUGS & PHARMACEUTICALS LIMITED # 304, Mohan Place, Local Shopping Complex, Block - C, Saraswati Vihar, New Delhi – 110034  
 
Primary Sponsor  
Name  AKUMS DRUGS & PHARMACEUTICALS LIMITED 
Address  # 304, Mohan Place, Local Shopping Complex, Block - C, Saraswati Vihar, New Delhi – 110034 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pinaki Roy  Calcutta Medical College  Department of gastroenterology, 88, College Street, Kolkata - 700073
Kolkata
WEST BENGAL 		 9474891727

drpinaki1979@gmail.com 
Dr Omesh Goyal  Dayanand Medical College and Hospital  Department of gastroenterology, Tagore Nagar, Civil Lines, Ludhiana, Punjab- 141001
Ludhiana
PUNJAB 		 9914821155

goyalomesh@yahoo.co.in 
Dr Vinay Kumar  GSVM Medical College  Department of gastroenterology, Swaroop nagar, Kanpur- 208002
Kanpur Nagar
UTTAR PRADESH 		 8004877113

pitrialsGSVM@gmail.com 
Dr Rushi Pipavat  Kanoria Hospital & Research centre  Department of gastroenterology, Airport- Gandhinagar Highway, Village-Bhat, Gandhinagar-382428, Gujarat
Ahmadabad
GUJARAT 		 9023446563

khrc.jalpa10@gmail.com 
Dr Manas Kumar Mondal  NRS Medical College & Hospital  Department of gastroenterology, 138, A .J. S Bose Road, Kolkata-700014.
Kolkata
WEST BENGAL 		 9073593833

drmanas.k.mondal@gmail.com 
Dr Rajesh Pedalimari  Rajalakshmi Hospital & Research Centre  Department of gastroenterology, 21/1, Lakshmipura Main Road, Vidyaranyapura Post, Bangalore -560097
Bangalore
KARNATAKA 		 8025234855

pendlimari.rajesh@gmail.com 
Dr Gautam Tamboliya  Unity Hospital  Department of gastroenterology,51 Shripal nagar Soc. Opp Pebble Bay flats, Nr. Ankini School, Chanadkheda, Ahmedabad, Gujarat-382424
Ahmadabad
GUJARAT 		 9925388997

omegabiopharmresearch@gmail.com 
Dr Maghavendra Kumar  Vidhya Hospital &Trauma Centre  Department of gastroenterology, Harikansh Garhi, Raebarli Road, Lucknow -226301
Lucknow
UTTAR PRADESH 		 9532989178

drmaghavendra2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Drug Trial Ethics Committee, Dayanand Medical College and Hospital  Submittted/Under Review 
Ethics Committee NRS Medical College, NRS Medical College & Hospital  Submittted/Under Review 
Ethics committee, GSVM Medical College  Approved 
Institutional Ethics Committee for Human Resesrch Medical college  Submittted/Under Review 
Institutional Ethics Committee, Rajalakshmi Hospital  Approved 
Kanoria Ethics Committee Kanoria Hospital & Research centre  Submittted/Under Review 
Sangini Hospital Ethics Committee  Approved 
Vidhya Hospital &Trauma Centre Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K219||Gastro-esophageal reflux disease without esophagitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  FDC of Acotiamide Hydrochloride Hydrate (As ER) 300 mg plus Pantoprazole IP 40 mg Capsule  Subjects shall be instructed to administer test or comparator product, once daily orally, for the duration of 12 weeks 
Comparator Agent  Pantoprazole IP 40 mg tablet  Subjects shall be instructed to administer test or comparator product, once daily orally, for the duration of 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male and female subjects between 18 to 65 years of age (both inclusive).
2. Patients with refractory GERD (erosive or non-erosive reflux disease confirmed by upper gastrointestinal endoscopy) i.e., those who have failed on conventional treatment. (Conventional treatment: Pantoprazole 40 mg tablet once daily for at least 8 weeks).
3. Subjects diagnostically confirmed of having Functional Dyspepsia (FD) with no evidence of gastric and duodenal organic abnormality by upper gastrointestinal endoscopy.
4. Patients who have experienced heartburn symptom on at least 2 of 7 days and regurgitation symptom on at least 1 of 7 days for at least 8 weeks prior to enrolment.
5. Female Subjects, of childbearing potential practicing an acceptable method of birth control such as sexual abstinence, intrauterine device IUD, a double-barrier method, condom plus spermicide, diaphragm plus spermicide, or vaginal spermicidal suppository; for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same should be used during treatment. OR Postmenopausal for at least 1 year. OR Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/ hysterectomy has been performed on the Subject).
6. Subjects who are able to understand and give voluntary, written informed consent to participate in this clinical investigation.
7. Subjects shall be willing, able to comply with the protocol requirements.
 
 
ExclusionCriteria 
Details  1. Subjects using Proton Pump Inhibitor (PPI) other than pantoprazole.
2. Subjects planning to take an inhibitor of gastric acid secretion other than Pantoprazole, a prokinetic drug other than Acotiamide, or any herbal medicine for gastrointestinal disorders.
3. Subjects who had undergone total gastrectomy.
4. Subjects with symptoms of Irritable Bowel Disease (IBD).
5. Patients chronically (> 5 doses on demand or for 3 consecutive days) using systemic corticosteroids or non-steroidal anti-inflammatory drugs including COX-2 inhibitors other than aspirin (less than or equal to 325 mg is allowed) within last 28 days prior to screening. Need for continuous anticoagulant therapy
6.Current or past history of:
- Patients with gastrointestinal hemorrhage, mechanical obstruction or perforation
- Atrophic gastritis or documented gastric malignancy or other GI malignancy
- History of active gastric or duodenal ulcers within 4 weeks prior to screening.
- Patients with Zollinger-Ellision syndrome or other hypersecretory condition
- GERD complications like Barretts oesophagus and/or definite dysplastic changes in the oesophagus.
- Pyloric stenosis, oesophageal stricture, Schatzkis ring, oesophageal or Gastroesophageal surgery and planned surgery during the study duration.
- History of hematemesis within last 2 months.
- Clinically significant conditions as per investigator discretion.
7. Subjects with history of liver, gallbladder, and pancreatic disorders.
8. Subjects confirmed positive for Helicobacter pylori by the rapid urease test.
9. Subjects with abnormal eGFR (< 60 mL/min/1.73 m2) will be excluded from the study.
10. Subjects with abnormal Liver Function Test (AST & ALT) with values more than 2.5 times the upper limit of normal.
11. Subjects with known case of Oncological Conditions.
12. Subjects with known history of infection with HIV, Hepatitis B virus or Hepatitis C virus.
13. Subject with any clinically significant laboratory abnormalities at screening as per investigator discretion.
14. Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results.
15. Suspected hypersensitivity to Pantoprazole or Acotiamide or any of the ingredients of the formulation.
16. Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
17. Female subjects who are not ready to use acceptable contraceptive methods during the course of study.
18. Female subjects with positive urine pregnancy test at screening.
19. Subjects with drug abuse or having any condition that would compromise compliance with this protocol.
20. Subjects who have been treated with an investigational drug or investigational device within a period of 4 weeks prior to study entry.
21. Currently taking prohibited concomitant medication(s) listed and inability/unwillingness to discontinue them for the entire study period.
22. Suspected inability or unwillingness to comply with the study procedures
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients in the two treatment groups with ≥ 50% reduction (responders) from baseline to end of treatment (Week 12) in the total score for three upper gastrointestinal symptoms (heartburn, epigastralgia, and epigastric fullness) in the Izumo scale  Visit 1: Screening Visit ; Visit 2:Randomization/Baseline Visit;
Visit 3 & 4: Interim Visits; Visit 5: End of Treatment/Early Termination Visit
 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of the difference (from baseline to end of treatment (Week 12)) in each score between two treatment groups for each symptom (total, three upper gastrointestinal symptoms, heartburn, epigastralgia, epigastric fullness, constipation, and diarrhoea) in the Izumo scale  Visit 1: Screening Visit ; Visit 2:Randomization/Baseline Visit;
Visit 3 & 4: Interim Visits; Visit 5: End of Treatment/Early Termination Visit
 
Evaluation of the FSSG scale scores for each symptom (total score, FD score, and GERD score) and comparison of the differences (from baseline to end of treatment (Week 12)) in each score between two treatment groups.   Visit 1: Screening Visit ; Visit 2:Randomization/Baseline Visit;
Visit 3 & 4: Interim Visits; Visit 5: End of Treatment/Early Termination Visit 
Proportion of patients with endoscopically confirmed healing of reflux oesophagitis after 12 weeks compared to baseline  Visit 1: Screening Visit ; Visit 2:Randomization/Baseline Visit;
Visit 3 & 4: Interim Visits; Visit 5: End of Treatment/Early Termination Visit. 
 
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)   05/05/2023 
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)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

After informed consent process, completion of all screening assessments and once all the inclusion/exclusion criteria are met, the eligible subjects shall be enrolled into the study. Demographics, Medical and surgical history shall be recorded during screening visit. Physical examination shall be done during screening and each successive visit. Vital signs shall be measured during screening and each successive visit. Details of concomitant medications and adverse events if any shall be recorded during each visit. 

At randomization/baseline visit, subjects shall be randomly (Double blind) assigned in 1:1 fashion to one of the two treatment groups. Subjects shall be instructed to administer, test or comparator product, once daily orally, for the duration of 12 weeks. Study medication shall be swallowed whole and should not be opened, crushed, or chewed.

An adverse event and concomitant medication forms will be provided to subjects to record details of adverse events and concomitant medications if any. 

 
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