CTRI/2021/11/038098
Completed
Phase 4
Prospective, Non-interventional, Multi-centre, Post Marketing Surveillance Study to Evaluate the Safety and Tolerability of Gaviscon Oral Suspension for the Management of Symptoms of Gastroesophageal Reflux Disease. - GOPI
Reckitt Benckiser Health Limited UK0 sites590 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis
- Sponsor
- Reckitt Benckiser Health Limited UK
- Enrollment
- 590
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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