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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02470117
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
Vorapong Phupong, Chulalongkorn University

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.

Condition or disease Intervention/treatment Phase
Heartburn in Pregnancy Drug: Alginate-based reflux suppressant Drug: magnesium-aluminium antacid gel Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD Heartburn

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



Primary Outcome Measures :
  1. Frequency of heartburn as measured by diary chart [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Intensity of hearburn as measured by visual analog scale [ Time Frame: 2 weeks ]
  2. satisfaction as measured by questionnaire [ Time Frame: 2 weeks ]
  3. quality of life as measured by questionnaire SF-8 [ Time Frame: 2 weeks ]
  4. Number of participants with side effects [ Time Frame: 2 weeks ]
  5. fetal outcomes as measured by birth weight and Apgar scores [ Time Frame: at birth ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470117


Locations
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Thailand
Vorapong Phupong
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
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Study Director: Vorapong Phupong, M.D. Chulalongkorn University
Publications of Results:
Other Publications:
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Responsible Party: Vorapong Phupong, Prof. Vorapong Phupong, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02470117    
Other Study ID Numbers: 567/57
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Heartburn
Signs and Symptoms, Digestive
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents