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Efficacy and Safety Evaluation of Neobianacid® in GERD and EPS

NCT03238534 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2022-11-21

No results posted yet for this study

Summary

Comparison of Neobianacid® clinical efficacy to omeprazole in relief of heartburn or epigastric pain

Conditions

  • GERD
  • EPS

Interventions

DEVICE

Neobianacid®

Oral administrations of Neobianacid® (30' after meals and on demand)

DRUG

Omeprazole 20mg

Daily administration Omeprazole 20mg (per os, 30' before breakfast).

OTHER

Neobianacid® placebo

Oral administrations of Neobianacid® placebo (30' after meals and on demand)

OTHER

Omeprazole placebo

Daily administration Omeprazole placebo (per os, 30' before breakfast).

Sponsors & Collaborators

  • Doppel Farmaceutici

    collaborator UNKNOWN

  • University of Roma La Sapienza

    collaborator OTHER

  • BMR Genomics

    collaborator UNKNOWN

  • Aboca Spa Societa' Agricola

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-09-12
Primary Completion
2021-09-03
Completion
2021-09-03

Countries

  • Italy

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 NCT03238534 on ClinicalTrials.gov