| CTRI Number |
CTRI/2025/10/096431 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| 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 1000 mg and Potassium hydrogen carbonate Ph EUR 200 mg in 320 Patients with Gastroesophageal Reflux Disease (GERD) or acidity. |
|
Scientific Title of Study
|
A Multicenter, Post-marketing Surveillance Study to Evaluate the Safety and Effectiveness of Fixed Dose Combination of Sodium Alginate IP 1000 mg and Potassium hydrogen carbonate Ph EUR 200 mg Oral Suspension in Patients with Gastroesophageal Reflux Disease (GERD) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SAPO-521-0131, Version 3.1 dated 17 Jun 22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivani Acharya |
| Designation |
Director- Clinical Development & Operation |
| Affiliation |
Abbott India Limited |
| Address |
Abbott India Limited, Godrej BKC, Plot No C-68, Bandra Kurla Complex, Bandra East
Abbott India Limited, Godrej BKC, Plot No C-68, Bandra Kurla Complex, Bandra East
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02250460456 |
| Fax |
|
| Email |
shivani.acharya@abbott.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Acharya |
| Designation |
Director- Clinical Development & Operation |
| Affiliation |
Abbott India Limited |
| Address |
Abbott India Limited, Godrej BKC, Plot No C-68, Bandra Kurla Complex, Bandra East
Abbott India Limited, Godrej BKC, Plot No C-68, Bandra Kurla Complex, Bandra East
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02250460456 |
| Fax |
|
| Email |
shivani.acharya@abbott.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Acharya |
| Designation |
Director- Clinical Development & Operation |
| Affiliation |
Abbott India Limited |
| Address |
Abbott India Limited, Godrej BKC, Plot No C-68, Bandra Kurla Complex, Bandra East
Abbott India Limited, Godrej BKC, Plot No C-68, Bandra Kurla Complex, Bandra East
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02250460456 |
| Fax |
|
| Email |
shivani.acharya@abbott.com |
|
|
Source of Monetary or Material Support
|
| Ms Abbott India Limited, 3, Corporate Park, Sion- trombay Park, Maharashtra (India)- 400071 |
|
|
Primary Sponsor
|
| Name |
Ms Abbott India Limited |
| Address |
Ms Abbott India Limited, 3, Corporate Park, Sion- trombay Park, Maharashtra (India)- 400071 |
| 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 SSVV Narasinga Rao |
Government Medical College & 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
Srikakulam
ANDHRA PRADESH |
9908611119
drnarasingaraossvv@yahoo.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 |
09820324286
drshahdilip@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| 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 General Hospital, Srikakulam |
Approved |
| Shah Lifeline Hospital and Heart Institute EC |
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 |
| Comparator Agent |
NA |
NA |
| Intervention |
Sodium Alginate IP 1000 mg and Potassium hydrogen carbonate Ph EUR 200 mg |
Each patient will take 5-10 mL of oral suspension after meals and at bedtime for 7 days. The oral suspension contains sodium alginate IP 1000 mg and potassium hydrogen carbonate Ph EUR 200 mg per 10 mL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a. Male and female patients above 18 years and up to 60 years of age.
b. Patients who are suffering with GERD are prescribed the FDC oral suspension as per the approved prescribing information in accordance with clinical practice.
c. Patients willing to sign patient authorization form (PAF).
|
|
| ExclusionCriteria |
| Details |
1. Patients with highly restricted salt/sodium diet e.g., cases of congestive cardiac failure, renal impairment, hypertension, and edema states.
2. Patients of hypercalcemia, nephrocalcinosis, and recurrent calcium containing renal calculi.
3. Patients with 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.
4. Patients with highly restricted potassium diet.
5. Patients taking any medications 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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patients with highly restricted salt/sodium diet e.g., cases of congestive cardiac failure, renal impairment, hypertension, and edema states.
Patients of hypercalcemia, nephrocalcinosis, and recurrent calcium containing renal calculi.
Patients with 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.
Patients with highly restricted potassium diet.
Patients taking any medications which might interfere with the action of the FDC oral suspension prior to the start of the study.
Female patients who are pregnant or are nursing mothers.
Patients who are determined to be at risk of COVID-19
|
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of patients achieving adequate heartburn or regurgitation relief after 7 days of treatment on following 4-point scale-
0 = none (no symptom)
1 = mild (symptoms were easily tolerated, the discomfort was only minimal and did not affect normal activities)
2 = moderate (symptoms were sufficient to affect normal activities)
3 = severe (symptoms markedly affected normal activities)
Change in mean GERD Symptom Assessment Scale (GSAS) distress score from baseline.
Mean change in total daily duration (in minutes/hours) of heartburn, regurgitation, or indigestion over last 7 days from baseline
Percentage of patients who experience night-time heartburn, regurgitation or indigestion in the preceding night from baseline to 7 days after treatment
|
7 days |
|
|
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)
|
31/10/2025 |
| 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="0"
Months="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a multicenter post-marketing surveillance study to evaluate the safety and effectiveness of the Fixed dose combination (FDC) of Sodium Alginate IP 1000 mg and Potassium hydrogen carbonate Ph EUR 200 mg oral suspension in patients with GERD. Approximately 320 patients suffering with GERD who have been prescribed the FDC oral suspension as per the approved prescribing information in accordance with clinical practice and are willing to sign the patient authorization form (PAF), will be eligible to participate in the study. The study will involve clinical assessments of patients at baseline visit (Day 1, Visit 1) and at or closest to 7 days after treatment with the FDC oral suspension (Visit 2). The FDC oral suspension will be prescribed by the investigator as a part of routine clinical practice, independent of the decision to include the patient in the study. The FDC oral suspension will not be provided by the Sponsor. Each patient will take the FDC oral suspension (5-10 mL after meals and at bedtime) as per the prescribing information of the FDC for 7 days. A diary will be provided to the patients to record their clinical symptoms. If the clinical symptoms do not improve after 7 days, the clinical situation will be reviewed by the investigator. |