NCT03238534

Efficacy and Safety Evaluation of Neobianacid® in GERD and EPS

Relief of Heartburn and Epigastric Pain Comparing Neobianacid® With Omeprazole: a Randomized, Double Blind, Double Dummy, Reference Product Controlled, Parallel Group, Non-inferiority Clinical Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: Aboca Spa Societa' Agricola · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Comparison of heartburn or epigastric pain severity following administration of Neobianacid® (Group B) or omeprazole (Group A) from day 0 to day 27. An ad-hoc placebo will be also administered in both treatment arms. Then, a following phase (day 28-55) will follows in which Neobianacid® will be administered (on demand) to both treatment arms.

Conditions

• GERD
• EPS

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2017-09-12
• Primary completion: 2021-09-03
• Completion: 2021-09-03
• First posted: 2017-08-03
• Last updated: 2022-11-21

Locations

12 sites across 1 country: Italy