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

July 26, 2016 updated by: Vorapong Phupong, Chulalongkorn University

Comparison of the Efficacy of Alginate-based Reflux Suppressant and Magnesium-aluminium Antacid Gel for Treatment of Heartburn in Pregnancy : A Randomized Double-Blind Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Vorapong Phupong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Alginate-based reflux suppressant
Alginate-based reflux suppressant 15 ml oral every 6 hours for 2 weeks
Drug: Alginate-based reflux suppressant
Sham Comparator: magnesium-aluminium antacid gel
magnesium-aluminium antacid gel 15 ml oral every 6 hours for 2 weeks
Drug: magnesium-aluminium antacid gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of heartburn as measured by diary chart
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Intensity of hearburn as measured by visual analog scale
Time Frame: 2 weeks
2 weeks
satisfaction as measured by questionnaire
Time Frame: 2 weeks
2 weeks
quality of life as measured by questionnaire SF-8
Time Frame: 2 weeks
2 weeks
Number of participants with side effects
Time Frame: 2 weeks
2 weeks
fetal outcomes as measured by birth weight and Apgar scores
Time Frame: at birth
at birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Study Director: Vorapong Phupong, M.D., Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

June 5, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (Estimate)

June 12, 2015

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 567/57

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heartburn in Pregnancy

Clinical Trials on Alginate-based reflux suppressant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe