Alginate-based Reflux Suppressant and Magnesium-aluminium Antacid Gel for Treatment of Heartburn in Pregnancy

Chulalongkorn University

Status and phase: Completed; Phase 4

Conditions: Heartburn in Pregnancy

Treatments: Drug: Alginate-based reflux suppressant; Drug: magnesium-aluminium antacid gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02470117

567/57

Details and patient eligibility

About

This study evaluates the efficacy of alginate-based reflux suppressant and magnesium-aluminium antacid gel for treatment of heartburn in pregnancy. Half of the participants will receive alginate-based reflux suppressant, while the other half will receive magnesium-aluminium antacid gel.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women gestational age less than 36 weeks with heartburn

Exclusion criteria

• Having medical disease that contraindicated to use study drug
• Allergic to alginate-based reflux suppressant and magnesium-aluminium antacid gel

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Alginate-based reflux suppressant

Active Comparator group

Description:

Alginate-based reflux suppressant 15 ml oral every 6 hours for 2 weeks

Treatment:

Drug: Alginate-based reflux suppressant

magnesium-aluminium antacid gel

Sham Comparator group

Description:

magnesium-aluminium antacid gel 15 ml oral every 6 hours for 2 weeks

Treatment:

Drug: magnesium-aluminium antacid gel