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

NCT04130659 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-12-15

No results posted yet for this study

Summary

Many patients with acid reflux disease do not improve with regular doses of proton pump inhibitors (e.g., omeprazole). The goals of this clinical trial is the to see if taking MARIAL®, in combination with omeprazole, for one month improves symptoms of acid reflux disease compared to taking omeprazole alone.

Furthermore, this study will verify the effectiveness of MARIAL® as a maintenance treatment for the next five months.

This trial is called by the registered name GENYAL®.

Conditions

  • Gastroesophageal Reflux Disease (GERD)

Interventions

COMBINATION_PRODUCT

MARIAL® + PPI (generic Omeprazole)

MARIAL® administration: 1 stick twice daily after meals from day 1 to 28. Omeprazole administration: 20 mg cps once daily from day 1 to day 28

DRUG

PPI alone (generic omeprazole)

Omeprazole administration: 20 mg cps once daily from day 1 to day 28

DEVICE

MARIAL® alone

MARIAL® administration: 1 stick twice daily after meals from day 29 to month 6.

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • Nekkar Lab Srl

    lead INDUSTRY

Principal Investigators

  • Doina Rosu · Societatea Civilă Medicală Gados

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-08
Primary Completion
2024-12-31
Completion
2025-01-31

Countries

  • Italy
  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04130659 on ClinicalTrials.gov