| CTRI Number |
CTRI/2025/05/087406 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the effect of Fixed Dose Combination of Sodium Alginate 250 mg, Sodium Bicarbonate 106.5 mg and Calcium Carbonate 187.5 mg Chewable tablets for the management of symptoms of gastroesophageal reflux disease
|
|
Scientific Title of Study
|
A Prospective, Non-Interventional, Multicentric, Single arm, Open Label, Post Marketing Surveillance Clinical Study to Evaluate the Safety and Efficacy of FDC of Sodium Alginate 250 mg, Sodium Bicarbonate 106.5 mg and Calcium Carbonate 187.5 mg Chewable tablets for the Management of Symptoms of Gastroesophageal Reflux Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BRPL/CT/FDC/SSCC/06/22; Version 2.0; Date: 24 May 2023 |
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 |
1st Floor, Ajmera Nucleus, 424C, next to Mahindra Tech Park, Shanthipura, Electronic city Phase 2
Bangalore
KARNATAKA
560100
India |
| Phone |
8026667707 |
| 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 |
1st Floor, Ajmera Nucleus, 424C, next to Mahindra Tech Park, Shanthipura, Electronic city Phase 2
Bangalore
KARNATAKA
560100
India |
| Phone |
8026667707 |
| 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 |
1st Floor, Ajmera Nucleus, 424C, next to Mahindra Tech Park, Shanthipura, Electronic city Phase 2
Bangalore
KARNATAKA
560100
India |
| Phone |
8026667707 |
| Fax |
|
| Email |
aditi.datta@biositeindia.com |
|
|
Source of Monetary or Material Support
|
| AKUMS DRUGS & PHARMACEUTICALS LIMITED;Plot No. 131 to 133, Block –C Mangolpuri Industrial Area, Phase –I, New Delhi -110083 |
|
|
Primary Sponsor
|
| Name |
AKUMS DRUGS & PHARMACEUTICALS LIMITED |
| Address |
Plot No. 131 to 133, Block –C Mangolpuri Industrial Area, Phase –I, New Delhi -110083 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Akums Drugs Pharmaceuticals Ltd |
Akums Drugs & Pharmaceuticals Ltd,19-21, Sector 6A, IIE, SIDCUL, Ranipur, Haridwar-249403, Uttarakhand. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohd Fareed |
Centrum Maternity Centre & Hospital |
MIG-83 Ganga Vihar Colony, Jajmau, Kanpur-208010, UP, India
Kanpur Nagar
UTTAR PRADESH |
9918599844
fareed0175@gmail.com |
| Dr Ashish Rajendra Gandhi |
Gajanan Hospital and Critical Care Centre |
Near Gajanan Maharaj temple chowk Opposite Axis Bank Besides LIC office Garkheda road Aurangabad-431005 Maharashtra India
Aurangabad
MAHARASHTRA |
9762947904
ashishrgandhi@gmail.com |
| Dr Vinay Kumar |
GSVM Medical College, Kanpur |
Post Graduate Department of Medicine GSVM Medical College Kanpur 208002 UP India
Kanpur Nagar
UTTAR PRADESH |
8004877113
dr.vinaysachan@gmail.com |
| Dr Arka Banerjee |
Institute of Post Graduate Medical Education & Research and SSKM Hospital |
Institute of Post Graduate Medical Education and Research and SSKM Hospital 244 Acharya Jagadish Chandra Bose Road Kolkata-700020 West Bengal India.
Kolkata
WEST BENGAL |
9433454747
dr.arkobanerjee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee of lshwar Institute of HealthCare |
Approved |
| Ethics Committee, GSVM Medical College |
Approved |
| Ethics Committee, Raja Nursing Home |
Approved |
| IPGME and R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 250 mg, Sodium Bicarbonate 106.5 mg and Calcium Carbonate 187.5 mg Chewable tablets |
Patients will be instructed to administer Fixed Dose Combination of Sodium Alginate 250 mg, Sodium Bicarbonate 106.5 mg and Calcium Carbonate 187.5 mg Chewable tablets i.e., two Chewable tablets four times a day (after each meal and at bedtime), orally for 7 days of treatment duration. Chew thoroughly before swallowing. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and Female patients more than 18 years of age.
2. Patients who have been prescribed FDC of Sodium Alginate Sodium Bicarbonate and Calcium Carbonate Chewable tablets for the treatment of reflux related symptoms in line with the marketing authorization during the last 24 hours prior to the study screening.
3. Patients who have experienced reflux related symptoms such as heartburn and or regurgitation during the 48-hour prior to the study screening.
4. Patients willing to sign informed consent form. |
|
| ExclusionCriteria |
| Details |
1. Patients with highly restricted salt/sodium diet e.g., in some cases of cardiac failure, renal impairment, hypertension, and edema states.
2. Patients with known cases of hypercalcemia, nephrocalcinosis and recurrent calcium containing renal calculi.
3. Patients with known or suspected hypersensitivity to the active substance or any of the excipients.
4. Patient who has taken FDC of Sodium Alginate, Sodium Bicarbonate and Calcium Carbonate Chewable tablets during the last 12 weeks (except for the previous 24 hours),
5. Patients with any other conditions or diseases that an investigator considers it as inappropriate to enter the study as per the approved label.
6. Patients taking any medications which might interfere with the action of sodium alginate Chewable tablets prior to the start of the study.
7. Patient with history of received an investigational product or participation in another trial involving a marketed or investigational drug in the past 90 days prior to screening.
8. Patients who have an employee at the site or a partner or first-degree relative of the investigator.
9. Patient who has already previously enrolled in this study.
10. Female patients who are pregnant or planning to become pregnant or nursing mothers.
11. Patient not willing to comply with all aspects of the protocol requirements. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate proportion of patients with adverse events reported during the study. |
Visit 2 (Day 0), Visit 3 (Day 7) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Safety Endpoints (assessment of Laboratory parameters, Vital signs)
|
Visit 2 (Day 0), Visit 3 (Day 7)
|
Change in Modified DeMeester clinical symptoms score of heartburn & regurgitation
|
Visit 2 (Day 0), Visit 3 (Day 7) |
| Change in Modified FSSG Score |
Visit 2 (Day 0), Visit 3 (Day 7) |
| Patients overall satisfaction at the end of study. |
Visit 3 (Day 7) |
|
|
Target Sample Size
|
Total Sample Size="501"
Sample Size from India="501"
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)
|
05/06/2025 |
| 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
|
A Prospective Non interventional Multicentric Single arm Open Label PMS Clinical Study to Evaluate the Safety and Efficacy of FDC of Sodium Alginate 250 mg Sodium Bicarbonate 106.5 mg and Calcium Carbonate 187.5 mg Chewable Tablets for the management of symptoms of gastroesophageal reflux disease. Patients will be instructed to administer Fixed Dose Combination of Sodium Alginate 250 mg Sodium Bicarbonate 106 .5 mg and Calcium Carbonate 187.5 mg Chewable tablets i.e. two tablets four times a day after each meal and at bedtime orally for 7 days of treatment duration
Following are the subject study visits: Visit 1 Screening Visit Day -1 to Day 0 Visit 2 Baseline Visit Day 0 Visit 3 End of Study Visit Early Termination Visit Day 7
This is a single arm and open label study. Patients will be assigned into single group to receive test product. So, randomization procedure is not required.
This is an open label study. So, blinding procedure is not necessary. Statistical Analysis Plan SAP shall be finalized prior to database lock. The SAP shall include detailed statistical aspects of the efficacy and safety analysis. Statistical tests shall be conducted at the 5 Percent significance level unless otherwise indicated |