A post marketing surveillance study to evaluate the safety and tolerability of Gaviscon Double Action Oral Suspension and Gaviscon Double Action Tablets in patients with Gastroesophageal Reflux Disease

Phase 4

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

• Registration Number: CTRI/2024/02/062711
• Lead Sponsor: Reckitt Benckiser Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patient is willing to provide informed consent and able to comply with all study requirements, including attendance at follow-up visits

2. Patient is male or female and aged: = 18 years of age.

3. Within the previous 24 hours, patient has been prescribed Gaviscon Double Action Oral Suspension or Tablets for the treatment of reflux related symptoms in line with the marketing authorisation

4. Patient has experienced reflux related symptoms (such as heartburn and/or regurgitation) within the 48-hour period prior the screening visit and on at least two other days within the week before screening.

Exclusion Criteria

1. Patient with any previous history of allergy or known intolerance to any of the ingredients in the formulations including, Sodium alginate, Sodium bicarbonate, Calcium carbonate or hydroxybenzoate (parabens) and excipients.

2. Except for the previous 24 hours, patient has taken Gaviscon Double Action Oral Suspension or Tablets in the past 12 weeks.

3. Patients with any co-existing condition or taking medication which, in the opinion of the Investigator, would be likely to compromise patient safety. In particular, caution should be exerted for patients with hypertension, renal or cardiac failure, oedema or hypercalcemia. In addition, a time-interval of 2 hours should be considered between intake of this product and the administration of other medicinal products, especially H2-antihistaminics, tetracyclines, digoxin, fluoroquinolones, iron salts, thyroid hormones, ketoconazole, neuroleptics, thyroxine, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoid, chloroquine, diphosphonates, and estramustine.

4. Patient has received an investigational product or participated in another trial involving a marketed or investigational drug in the 90 days prior to screening.

5. Patient, in the opinion of the Investigator, is unable to comply fully with the study requirements.

6. Patient who is an employee at the site or a partner or first-degree relative of the Investigator.

7. Patient has been previously enrolled in this study.

8. Patient fails to satisfy the investigator of fitness to participate for any other reason.

Study & Design

• Study Type: PMS
• Study Design: Not specified