Status:
UNKNOWN
Efficacy of Zinc L-carnosine in Maintaining Remission of Gastroesophageal Reflux Disease
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Gastroesophageal reflux disease (GERD), according to the Montreal classification, is defined as a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complic...
Detailed Description
The investigators hypothesise that Zinc-l-carnosine is able to maintain GERD remission, thus improving the quality of life of these patients. A comparison with a placebo is necessary, as GERD symptoms...
Eligibility Criteria
Inclusion
- written informed consent to participate
- be male or female patients ≥ 18 years old, with an established diagnosis of GERD
- have a diagnosis of GERD that is established clinically in case of typical symptoms (heartburn and acid regurgitation ≥ once weekly) or with 24-hour esophageal impedence monitoring in case of atypical symptoms not responsive to proton pump inhibitors (PPIs) or in case of unclear diagnosis
- have been treated with an 8-week course of PPI (as per gold-standard treatment of GERD) before entering the study
Exclusion
- any medical condition that requires chronic therapy with PPIs or H2 antagonists; anti-acid agents must be discontinued within the study period
- oesophageal motility disorders
- allergy or intolerance to Hepilor® (it contains parahydroxybenzoate that may cause allergies)
- inconclusive diagnosis of GERD and related symptoms
- patients with active H. pylori infection (diagnosed with any of the available tests)
- previous major oesophageal surgery
- history of any advanced/relevant organ dysfunction, in particular chronic kidney disease, chronic liver disease of any aetiology, hearth failure
- any concomitant medical condition with a poor prognosis (\< 3 months)
- pregnant females
- inability to conform to the protocol
- treatment with any investigational drug within the previous 3 months
- any subject not able to express/understand the informed consent
Key Trial Info
Start Date :
November 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03467438
Start Date
November 22 2018
End Date
April 1 2021
Last Update
February 26 2019
Active Locations (1)
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1
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100