| CTRI Number |
CTRI/2021/04/033028 [Registered on: 22/04/2021] Trial Registered Prospectively |
| Last Modified On: |
15/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
This study is planned in multiple centers in India, to determine the safety and effectiveness of oral suspension which is a Fixed Dose Combination of sodium alginate 250 mg, sodium bicarbonate 133.5 mg and calcium carbonate 80 mg in the treatment of heartburn and indigestion. |
|
Scientific Title of Study
|
A Multicentric, Post marketing Surveillance Study to Evaluate the Safety and Effectiveness of Fixed Dose Combination of Sodium Alginate 250 mg, Sodium Bicarbonate 133.5 mg and Calcium Carbonate 80 mg Oral Suspension in Patients with Heartburn and Indigestion |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SASC4001_ v1.0 dt 05.12.2019, amendment 01 dt 31.12.2020 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Mahesh N Belhekar |
| Designation |
Associate Professor |
| Affiliation |
Seth GS Medical College & KEM Hospital |
| Address |
Seth GS Medical College & KEM Hospital,
Department of Clinical Pharmacology,
New Building, Acharya Donde Marg,
Parel-East, Mumbai-400012, India.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
belhekardrmahesh4@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Mahesh N Belhekar |
| Designation |
Associate Professor |
| Affiliation |
Seth GS Medical College & KEM Hospital |
| Address |
Seth GS Medical College & KEM Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
belhekardrmahesh4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Praveena V Manglorkar |
| Designation |
V.P - QA & Regulatory Affairs |
| Affiliation |
Naxpar Pharma Pvt. Ltd. |
| Address |
Naxpar Pharma Pvt. Ltd.
104, Bldg. No.8, Jogani Ind. Estate, Sion, Mumbai – 22.
Mumbai
MAHARASHTRA
400022
India |
| Phone |
022-68252525 |
| Fax |
|
| Email |
praveena.m@naxparlab.com |
|
|
Source of Monetary or Material Support
|
|
|
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
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Partha Pratim Kalita |
Ayursundra Super Speciality Hospital |
Bhabanand Boro Path, Ahom Gaon, Garchuk, Guwahati
Kamrup
ASSAM |
7399737796
parthapratim.kalita@yahoo.in |
| Dr Jitendra Anand |
Kanoria Hospital & Research Centre |
Airport Road, Village-Bhat,
Gandhinagar Highway – 382428,
Gujarat, India.
Gandhinagar
GUJARAT |
9824517101
jkanand09@gmail.com |
| Dr Mahesh Belhekar |
Seth GS Medical Collee and KEM Hospital |
Department of Clinical Pharmacology, first Floor, Seth GS Medical College and KEM Hospital
Acharya Donde Marg, Parel, .
Mumbai
MAHARASHTRA |
9702006438
belhekardrmahesh4@gmail.com |
| Dr Indraneel Basu |
Shubham Sudbhawana Super Speciality Hospital |
B-31/80-23B-Bhogabeer Lanka
Varanasi-221005
Varanasi
UTTAR PRADESH |
9935036063
dribasumd@yahoo.co.in |
| Dr SR Ramakrishnan |
Sri Ramachandra Institute of higher Education and Research |
Clinical research Division, Dental College Basement, No.1, Ramachandra Nagar, Porur
Chennai
TAMIL NADU |
04424768403
drsrk_71@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Anand Ethics Committee |
Approved |
| Institutional Ethics Committee Shubham Sudbhawana Super Speciality Hospital |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE SRIHER |
Approved |
| Institutional Ethics Committee-l, KEM Hospital , Mumbai |
Approved |
| NECHRI Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Digeraft |
DigeraftTM contain the fixed dose combination (FDC) of sodium alginate 250 mg, sodium bicarbonate 133.5 mg and calcium carbonate 80 mg per 5 mL oral suspension.
Each patient will take sodium alginate oral suspension(10-20 mL after meals and at bedtime) as per the prescribing information(oral administration) of DigeraftTM for 7 days. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female patients above 18 years upto 60 years of age
2.Patients who are suffering with heartburn and indigestion and are prescribed DigeraftTM as per the approved label in accordance to clinical practice
3.Patients willing to sign patient authorization form (PAF)
|
|
| ExclusionCriteria |
| Details |
1.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.
2.Patients taking any medications which might interfere with the action of sodium alginate oral suspension prior to the start of the study
3.Female patients who are pregnant or nursing mothers
4.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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of the study is to evaluate safety and tolerability of sodium alginate oral suspension. |
End of Study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objective of the study is to evaluate the effectiveness of sodium alginate oral suspension. |
day 7, EOS |
|
|
Target Sample Size
|
Total Sample Size="320"
Sample Size from India="320"
Final Enrollment numbers achieved (Total)= "320"
Final Enrollment numbers achieved (India)="320" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/04/2021 |
| Date of Study Completion (India) |
15/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is a multicentric
post marketing surveillance study to evaluate the safety and effectiveness of
sodium alginate oral suspension in patients with heartburn and indigestion. The
study will be conducted at approximately 8 sites across India. Approximately
320 patients suffering with heartburn and indigestion who have been prescribed DigeraftTM as per the approved label in accordance to clinical
practice and are willing to sign the PAF will be eligible to participate in the
study.
Since, this is an Surveillance study, no additional
tests or interventions will be suggested; however, investigations done as a
part of routine clinical check-up as per investigator’s routine medical
practice will be captured.
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 sodium alginate oral suspension (Visit
2).
|