Study to Evaluate the Performance and Safety of the Marial in Association With PPI Versus PPI Alone
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Gastroesophageal Reflux Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized, open, comparative, multicenter study with two parallel groups of patients. At the end of the 28 days (± 1) 1st study period, patients will be admitted in an open non-comparative follow up (2nd study period) and treated with Marial® until 6 months from baselineMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04130659
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Investigators
- Principal Investigator: Doina Rosu Societatea Civil? Medical? Gados
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