| CTRI Number |
CTRI/2024/12/077951 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Evaluate the Safety and Effectiveness of Oral Suspension of Sodium Alginate IP 500 mg, Sodium Bicarbonate 213 mg and Calcium Carbonate IP 325 mg in Patients with Heartburn and Indigestion. |
|
Scientific Title of Study
|
A Multicenter, Post marketing Surveillance Study to Evaluate the Safety and Effectiveness of Fixed-Dose Combination of Sodium Alginate IP 500 mg, Sodium Bicarbonate 213 mg and Calcium Carbonate IP 325 mg Oral Suspension in Patients with Heartburn and Indigestion. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SASC-521-0185 Version 2.1 dated 21 June 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayashri Krishnan |
| Designation |
Vice President Operations |
| Affiliation |
JSS Medical Research Asia Pacific Private Limited |
| Address |
JSS Medical Research Asia Pacific Private Limited,
Tower 2, 1st Floor, South Wing, L&T Business Park,
Plot no 12/4, Sector 27 D, Faridabad Haryana
Faridabad
HARYANA
121003
India |
| Phone |
09771407484 |
| Fax |
|
| Email |
jayashri.krishnan@jssresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonika Newar |
| Designation |
General Manager- Medical Monitoring and Safety |
| Affiliation |
JSS Medical Research Asia pacific Private Limit |
| Address |
JSS Medical Research Asia Pacific Private Limited,
Tower 2, 1st Floor, South Wing, L&T Business Park,
Plot no 12/4, Sector 27 D, Faridabad Haryana
Faridabad
HARYANA
121003
India |
| Phone |
8800799887 |
| Fax |
|
| Email |
Sonika.newar@jssresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayashri Krishnan |
| Designation |
Vice President Operations |
| Affiliation |
JSS Medical Research Asia Pacific Private Limited |
| Address |
JSS Medical Research Asia Pacific Private Limited,
Tower 2, 1st Floor, South Wing, L&T Business Park,
Plot no 12/4, Sector 27 D, Faridabad Haryana
Faridabad
HARYANA
121003
India |
| Phone |
09771407484 |
| Fax |
|
| Email |
jayashri.krishnan@jssresearch.com |
|
|
Source of Monetary or Material Support
|
| Naxpar Pharma Pvt. Ltd, 104-107, Bldg. No.8, Jogani Industrial Estate, Chunabhatti, Sion, Mumbai- 400 022, India. |
|
|
Primary Sponsor
|
| Name |
Naxpar Pharma Pvt. Ltd, |
| Address |
104-107, Bldg. No.8, Jogani Industrial Estate, Chunabhatti, Sion, Mumbai- 400 022, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Naxpar Pharma Pvt Ltd |
182, Village Gurumajra, Kishanpura Tehsil Nalagarh
Solan, Baddi, Himachal Pradesh 174101 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hrishika Barua |
Ayursundra Superspeciality Hospital (Peerless Hospital) |
Bhabananda Boro Path, opposite DPS school, GARCHUK, Guwahati, Assam 781035
Kamrup
ASSAM |
9163046404
hrishikabarua@rediffmail.com |
| Dr K Sunil Naik |
Government MedicalCollege & Government General Hospital |
Department of Medicine, 1st Floor, OPD No.13, Government Medical College and Government General Hospital, Srikakulam, Andhra Pradesh – 532 001, India
Srikakulam
ANDHRA PRADESH |
9440828299
drsunilnaikggh@gmail.com |
| Dr Anil Samaria |
JLN Medical College |
Ground Floor, Room No. 104, Kala Bagh, Ajmer, Rajasthan 305001
Ajmer
RAJASTHAN |
9414008246
dr.anilsamaria@outlook.com |
| Dr Dilip Shah |
Kkasturi Medicare Pvt. Ltd. |
Harsh Niketan, Gaondevi Mandir Rd, behind Hotel Navarang, opposite Walchand Height, Bhayandar, Bhayandar West, Mira Bhayandar, Maharashtra 401101
Mumbai
MAHARASHTRA |
9820324286
drshahdilip@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| INS Trust Ethics Committee Ethics Committee Institute of Neurological Science Institute of Neurological Sciences Trust GNRC Complex Super Market Dispur Kamrup Metropolitan781006, Assam India |
Approved |
| Institutional Ethics Committee Jawahar Lal Nehru Medical College Kala Bagh, Ajmer, Rajasthan 305001 |
Approved |
| Institutional Ethics Committee, Government Medical College & Government General Hospital, Srikakulam, Andhra Pradesh – 532 001, India |
Approved |
| Shah Lifeline Hospital and heart institute EC, Geeta Nagar, Phase 7, Mira Bhayender Road, Nr. Fly over bridge, Mira Road East, Thane, Maharashtra- 401107 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Sodium Alginate IP 500 mg, Sodium Bicarbonate IP 213 mg and Calcium Carbonate IP 325 mg per 10 mL |
Each patient will take the FDC oral suspension (10-20 mL after meals and at bedtime, up to four times per day) as per the prescribing information of the fixed dose combination (FDC) of Sodium Alginate IP 500 mg, Sodium Bicarbonate IP 213 mg and Calcium Carbonate IP 325 mg per 10 mL oral suspension for 7 days. 10 mL oral suspension. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A patient will be considered eligible for inclusion in the study if he/she fulfils the following criteria:
1.Male and female patients ≥18 years and up to 60 years of age.
2.Patients diagnosed with heartburn and indigestion who have been prescribed the FDC oral suspension as per the approved prescribing information in accordance with clinical practice.
3.Patients willing to sign patient authorization form (PAF). |
|
| ExclusionCriteria |
| Details |
1.Patients will not be considered eligible for inclusion in this study if they meet any of the following criteria:
2.Patients with highly restricted salt/sodium diet e.g., cases of congestive cardiac failure, renal impairment, hypertension, and edema states.
3.Patients with history or ongoing illness of hypercalcemia, nephrocalcinosis, and recurrent calcium containing renal calculi.
4.Patients with history of known or suspected hypersensitivity to the active substances or any of the excipients; or suffering from any other conditions or diseases that an investigator considers as inappropriate to enter the study as per the approved prescribing information.
5.Patients taking any medications (e.g., proton pump inhibitors, H2 receptor blocking agents, antacids, or prokinetic agents) which might interfere with the action of the FDC oral suspension prior to the start of the study.
6.Female patients who are pregnant or are nursing mothers.
7.Patients who are determined to be at risk of COVID-19 as per investigator discretion. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number and percentage of patients with adverse drug reactions (ADRs) and/or Other Pharmacovigilance- Relevant Information (OPRIs) |
Number and percentage of patients who discontinue study treatment due to ADRs and/or OPRIs
Global tolerability assessment by patients and investigators after 7 days of treatment on a 3-point scale ranging from “good†to “poor†tolerability
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of patients achieving adequate heartburn or indigestion relief after 7 days of treatment.
Adequate heartburn or regurgitation relief was defined as no more than 1 day of mild heartburn or regurgitation episodes during the past 7 days post baseline visit.
|
Percentage of patients achieving adequate heartburn or indigestion relief after 7 days of treatment.
Adequate heartburn or regurgitation relief was defined as no more than 1 day of mild heartburn or regurgitation episodes during the past 7 days post baseline visit.
Daily severity of symptom according to the following four-point scale
0 none (no symptom)
1 mild symptom were easily tolerated, the discomfort was only minimal and did not affect normal activities
2moderate symptoms were |
|
|
Target Sample Size
|
Total Sample Size="320"
Sample Size from India="320"
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)
|
29/08/2025 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 multicenter post marketing surveillance study has been planned to assess the safety and effectiveness of FDC of Sodium alginate IP 500 mg, Sodium bicarbonate IP 213 mg and Calcium carbonate IP 325 mg per 10mL oral suspension in the treatment of patients (aged ≥18 years) with heartburn and indigestion as per the recommendations by the Indian Health Authorities. In this protocol henceforth FDC is referred as FDC of Sodium alginate IP 500 mg, Sodium bicarbonate IP 213 mg and Calcium carbonate IP 325 mg per 10mL oral suspension. The total study duration will be approximately 12-14 months (including enrolment period and 7 days of study treatment). |