Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis
Conditions
Interventions
Intervention1: NA: NA
Control Intervention1: NA: NA
Sponsors
Reckitt Benckiser Health Limited UK
Eligibility
Inclusion criteria
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: greater than equal to 18 years of age. 3. Patient has been prescribed Gaviscon Oral Suspension for the treatment of reflux related symptoms in line with the marketing authorisation. 4. Patient has experienced reflux related symptoms such as heartburn and regurgitation within the 48-hour period prior the screening visit and on at least two other days within the week before screening.
Exclusion criteria
Exclusion criteria: 1. Patient with any previous history of allergy or known intolerance to any of the Sodium alginate, Sodium bicarbonate, Calcium carbonate or hydroxybenzoate (parabens) and excipients. 2. Patient has taken Gaviscon Oral suspension 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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •The number of AE(s), type of AE(s), frequency of AE(s) and proportion of patients with AE(s). •The severity, seriousness and the relationship of AE(s) to treatment. Timepoint: Baseline, Week 4, Week 8 and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: None | — |
Countries
India
Contacts
Public ContactKarna Chary Akoju
Reckitt Benckiser (India) Pvt. Ltd.
Outcome results
None listed