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 Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- Enrollment
- 320
- Locations
- 5
- Primary Endpoint
- The primary objective of the study is to evaluate safety and tolerability of sodium alginate oral suspension.
Study Overview
Brief Summary
This is a multicentricpost marketing surveillance study to evaluate the safety and effectiveness ofsodium alginate oral suspension in patients with heartburn and indigestion. Thestudy will be conducted at approximately 8 sites across India. Approximately320 patients suffering with heartburn and indigestion who have been prescribed DigeraftTM as per the approved label in accordance to clinicalpractice and are willing to sign the PAF will be eligible to participate in thestudy.
Since, this is an Surveillance study, no additionaltests or interventions will be suggested; however, investigations done as apart of routine clinical check-up as per investigator’s routine medicalpractice will be captured.
The study will involveclinical assessments of patients at baseline visit (Day 1, Visit 1) and at orclosest to 7 days after treatment with sodium alginate oral suspension (Visit2).
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The primary objective of the study is to evaluate safety and tolerability of sodium alginate oral suspension.
Time Frame: End of Study
Secondary Outcomes
- The secondary objective of the study is to evaluate the effectiveness of sodium alginate oral suspension.(day 7, EOS)