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Study to Evaluate the Performance and Safety of the Marial in Association With PPI Versus PPI Alone

2019-10-23 13:11:48 | BioPortfolio

Summary

The Research Question of the present study is the following: in a group of patients affected by GERD, 1-month treatment with PPI (omeprazole) and Marial® will significantly decrease the use of Gaviscon® as rescue medicine in comparison with patients treated with omeprazole alone.

Description

This is an open-label, comparative, multicenter study with two parallel group of subjects. The clinical investigation will be performed in six clinical sites.

The study population will include subjects affected by GERD with diagnosis of Grade A esophagitis on Los Angeles Classification System grades reflux esophagitis, confirmed by gastroscopy (done within 1 month prior baseline).

Marial® is a class IIa medical device (Directive 93/42/EEC), already marketed in several EU countries. This compound has been produced combining hyaluronic acid, hydrolyzed keratin mucoproteins, glycoproteins such as fibronectin, meso glycans and integrins, and viscous agents. It evidenced to actively regenerate the damaged tissue by repairing and regenerative properties on mucous membranes and by muco-adhesive and film-forming characteristics that allow to prolong the contact time with the mucous membranes and consequently to improve the effectiveness.

Study Design

Conditions

Gastroesophageal Reflux Disease

Intervention

Marial® + PPI (generic omeprazole), PPI alone (generic omeprazole)

Location

Societatea Civilă Medicală Gados
Timişoara
Timis
Romania

Status

Recruiting

Source

Nekkar Lab Srl

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-23T13:11:48-0400

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Medical and Biotech [MESH] Definitions

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