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.

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) - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/10/096431

Enrollment

320

Registered

2025-10-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis

Interventions

Intervention1: 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 c

Eligibility

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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 Timepoint: 7 days	—

Measure

Time frame

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 Timepoint: 7 days

—

Secondary

Measure	Time frame
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 Timepoint: 7 days	—

Measure

Time frame

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 Timepoint: 7 days

—

Countries

India

Contacts

Public ContactDr Shivani Acharya

Abbott India Limited

shivani.acharya@abbott.com02250460456

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026