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CTRI Number  CTRI/2022/04/042137 [Registered on: 25/04/2022] Trial Registered Prospectively
Last Modified On: 25/04/2022
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Clinical Study of combination product to treat Gastro-esophageal Reflux Disease 
Scientific Title of Study   A Prospective, Single-arm, Multi-centric, Post-marketing Surveillance Study to Observe the Safety and Effectiveness of a Fixed Dose Combination of Sodium Alginate plus Sodium Bicarbonate plus Calcium Carbonate therapy in patients diagnosed with symptoms of Gastro-esophageal Reflux Disease 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
ET2106001 Version 01 Dated 17/09/21  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhaumik Mody 
Designation  Overall Trial Coordinator 
Affiliation  Ethitrials Contract Research Pvt. Ltd 
Address  Ethitrials Contract Research Pvt. Ltd. India, 916, Devpath Complex, B/h Lal Bungalow, Off C.G. Road, Navrangpura, Ahmedabad

Ahmadabad
GUJARAT
380009
India 
Phone  917940396978   
Fax    
Email  bhaumik.mody@ethitrials.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhaumik Mody 
Designation  Overall Trial Coordinator 
Affiliation  Ethitrials Contract Research Pvt. Ltd 
Address  Ethitrials Contract Research Pvt. Ltd. India, 916, Devpath Complex, B/h Lal Bungalow, Off C.G. Road, Navrangpura, Ahmedabad


GUJARAT
380009
India 
Phone  917940396978   
Fax    
Email  bhaumik.mody@ethitrials.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhaumik Mody 
Designation  Overall Trial Coordinator 
Affiliation  Ethitrials Contract Research Pvt. Ltd 
Address  Ethitrials Contract Research Pvt. Ltd. India, 916, Devpath Complex, B/h Lal Bungalow, Off C.G. Road, Navrangpura, Ahmedabad


GUJARAT
380009
India 
Phone  917940396978   
Fax    
Email  bhaumik.mody@ethitrials.com  
 
Source of Monetary or Material Support  
ESPI Industries & Chemicals Private Limited., M 7/2 Kakatiya Nagar, Habshiguda, Hyderabad 500007, Telangana, India 
 
Primary Sponsor  
Name  ESPI Industries Chemicals Private Limited 
Address  M-7/2 Kakatiya Nagar, Habshiguda, Hyderabad-500007, Telangana, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gauranga Sarkar  Health Point Hopsital  Roon no. 12 OPD Department, Health Point Hopsital, 21, Prannath Pandit Street, (Opp. Lansdown Padmapukur) Kolkata: 700 025
Kolkata
WEST BENGAL 		 9830165760

drgsmed@gmail.com 
Dr Amit Patel  Shreeji Hospita  Room no 1, OPD Department, Shreeji Hospital, Vallabhnagar Society,Odhav,Ahmedabad, 382415
Ahmadabad
GUJARAT 		 9825163863

dramitpatel4644@gmail.com 
Dr Sachin Gupta  Shubham Multispeciality Hopsital  Room no. 01 OPD Department, Shubham Multispeciality Hopsital, ABC complex, Rabari Colony Cross Road, Ahmedabad-380026
Ahmadabad
GUJARAT 		 07922870709

drsachingupta_21@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Health Point Ethics Committee  Approved 
Shubham Institutional Ethics Committee  Approved 
Shubham Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K210||Gastro-esophageal reflux disease with esophagitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fixed Dose Combination of Sodium Alginate IP 250mg plus Sodium Bicarbonate IP 133.5mg plus Calcium Carbonate IP 80mg  FDC of sodium alginate plus Sodium bicarbonate plus calcium carbonate oral suspension 10 ml, 3 times a day, after meals and at bedtime as per the prescribing information (oral administration) 
Comparator Agent  NIL   NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Male and non-pregnant female Patients diagnosed with symptoms of GERD aged 18 to 65 years (both inclusive).
2 Patients who are in requirement of FDC therapy of Sodium Alginate, Sodium Bicarbonate and Calcium Carbonate as per Investigator discretion.
3 Patients willing to follow the protocol requirements as evidenced by written informed consent.
4 Patients who having sufficient educational level and proficiency in reading and writing in their local language to be capable of reliably completing study questionnaires, as judged by the physician.

 
 
ExclusionCriteria 
Details  1 Participated in any clinical trial within 30 days prior to the start of the study.
2 Used histamine-2 receptor blockers, over the counter antacids, anticholinergic, cholinergic, spasmolytic, opiates, sucralfate, prokinetics, antibiotics or bismuth compounds within 14 days prior to the start of the study.
3 Any medical condition which might significantly interfere with the functioning of gastrointestinal tract and according to PI which may interfere with the treatment and makes the patients ineligible for participation in study.
4 Patients with highly restricted salt/sodium diet e.g. in some cases of congestive cardiac failure, renal impairment, hypertension, and edema states; patients with known cases of hypercalcemia, nephrocalcinosis, and recurrent calcium containing renal calculi; patients with known or suspected hypersensitivity to the active substance or any of the excipients; or any other conditions or diseases that an investigator considers it as inappropriate to enter the study as per the approved label.
5 Patients taking any medications which might interfere with the action of that FDC of sodium alginate + Sodium bicarbonate + calcium carbonate oral suspension prior to the start of the study
6 Female patients who are pregnant or breast-feeding.
7 Patients who are determined to be the risk group for COVID-19.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The patients’ assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) Heartburn/Regurgitation Subscale from baseline, to Day 28   28 Days 
 
Secondary Outcome  
Outcome  TimePoints 
1.The patients’ assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) Heartburn/Regurgitation Subscale from baseline, to Day 14
2.The patients’ assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) Fullness/ Early Satiety, Nausea/Vomiting, Bloating, Upper abdominal pain and Lower abdominal pain Subscale from baseline, to Day 14 and day 28.
3.The patients’ assessment of upper gastrointestinal disorders-Quality of Life (PAGI-QOL) Daily Activities, Clothing, Diet and Food habit, Relationship (REL),Physiological Well- being and Distress Subscale from baseline, to Day 14 and day 28.
4.To evaluate the patient’s overall treatment satisfaction on Day 14 and day 28.
5.Monitoring of adverse events and safety assessments, throughout the study period
 		 14 and 28 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   25/04/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This will be a Prospective, Single-arm, Multi-centric, Post-marketing Surveillance Study in Patients prescribed with FDC of Sodium alginate plus Sodium Bicarbonate plus Calcium Carbonate Therapy for symptoms of GERD.

The study will include 3 evaluation points,  visit 1 will screening/baseline visit at day (-10 to 0 days), visit 2 will be Interim visit at week 2 (Day 14 ± 2 days) and visit 3 will be end of study visit at week 4 (Day 28 ± 2 days).

 
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