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

NARecruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

August 8, 2019

Primary Completion Date

December 31, 2024

Study Completion Date

January 31, 2025

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.

Trial Locations (5)

45051

COMPLETED

Centrul Medical Salvosan Ciobanca, Zalău

300002

COMPLETED

Cabinet Particular Policlinic Algomed, Timișoara

300209

COMPLETED

Societatea Civilă Medicală Gados, Timișoara

300551

COMPLETED

Medlife SA, Timișoara

00168

RECRUITING

UOC Endoscopia Digestiva Chirurgica Policlinico Gemelli - Universita Cattolica, Roma

All Listed Sponsors
collaborator

Opera CRO, a TIGERMED Group Company

OTHER

lead

Nekkar Lab Srl

INDUSTRY