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

Primary Purpose

Heartburn in Pregnancy

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Alginate-based reflux suppressant
magnesium-aluminium antacid gel
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heartburn in Pregnancy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Vorapong Phupong

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Alginate-based reflux suppressant

magnesium-aluminium antacid gel

Arm Description

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

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

Outcomes

Primary Outcome Measures

Frequency of heartburn as measured by diary chart

Secondary Outcome Measures

Intensity of hearburn as measured by visual analog scale
satisfaction as measured by questionnaire
quality of life as measured by questionnaire SF-8
Number of participants with side effects
fetal outcomes as measured by birth weight and Apgar scores

Full Information

First Posted
June 5, 2015
Last Updated
July 26, 2016
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT02470117
Brief Title
Alginate-based Reflux Suppressant and Magnesium-aluminium Antacid Gel for Treatment of Heartburn in Pregnancy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heartburn in Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alginate-based reflux suppressant
Arm Type
Active Comparator
Arm Description
Alginate-based reflux suppressant 15 ml oral every 6 hours for 2 weeks
Arm Title
magnesium-aluminium antacid gel
Arm Type
Sham Comparator
Arm Description
magnesium-aluminium antacid gel 15 ml oral every 6 hours for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Alginate-based reflux suppressant
Intervention Type
Drug
Intervention Name(s)
magnesium-aluminium antacid gel
Primary Outcome Measure Information:
Title
Frequency of heartburn as measured by diary chart
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Intensity of hearburn as measured by visual analog scale
Time Frame
2 weeks
Title
satisfaction as measured by questionnaire
Time Frame
2 weeks
Title
quality of life as measured by questionnaire SF-8
Time Frame
2 weeks
Title
Number of participants with side effects
Time Frame
2 weeks
Title
fetal outcomes as measured by birth weight and Apgar scores
Time Frame
at birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vorapong Phupong, M.D.
Organizational Affiliation
Chulalongkorn University
Official's Role
Study Director
Facility Information:
Facility Name
Vorapong Phupong
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
15814238
Citation
Hampson FC, Farndale A, Strugala V, Sykes J, Jolliffe IG, Dettmar PW. Alginate rafts and their characterisation. Int J Pharm. 2005 Apr 27;294(1-2):137-47. doi: 10.1016/j.ijpharm.2005.01.036.
Results Reference
background
PubMed Identifier
23419381
Citation
Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013 Mar;108(3):308-28; quiz 329. doi: 10.1038/ajg.2012.444. Epub 2013 Feb 19. No abstract available. Erratum In: Am J Gastroenterol. 2013 Oct;108(10):1672.
Results Reference
background
PubMed Identifier
16831611
Citation
Mahadevan U, Kane S. American gastroenterological association institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology. 2006 Jul;131(1):283-311. doi: 10.1053/j.gastro.2006.04.049.
Results Reference
background
PubMed Identifier
231639
Citation
Malmud LS, Charkes ND, Littlefield J, Reilley J, Stern H, Rosenberg R, Fisher RS. The mode of action alginic acid compound in the reduction of gastroesophageal reflux. J Nucl Med. 1979 Oct;20(10):1023-8.
Results Reference
background
PubMed Identifier
16225482
Citation
Richter JE. Review article: the management of heartburn in pregnancy. Aliment Pharmacol Ther. 2005 Nov 1;22(9):749-57. doi: 10.1111/j.1365-2036.2005.02654.x.
Results Reference
background
PubMed Identifier
24096290
Citation
Quartarone G. Gastroesophageal reflux in pregnancy: a systematic review on the benefit of raft forming agents. Minerva Ginecol. 2013 Oct;65(5):541-9.
Results Reference
result
PubMed Identifier
23209926
Citation
Strugala V, Bassin J, Swales VS, Lindow SW, Dettmar PW, Thomas EC. Assessment of the Safety and Efficacy of a Raft-Forming Alginate Reflux Suppressant (Liquid Gaviscon) for the Treatment of Heartburn during Pregnancy. ISRN Obstet Gynecol. 2012;2012:481870. doi: 10.5402/2012/481870. Epub 2012 Nov 4.
Results Reference
result

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

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