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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

Tracking Information
First Submitted Date  ICMJE June 5, 2015
First Posted Date  ICMJE June 12, 2015
Last Update Posted Date July 27, 2016
Study Start Date  ICMJE June 2015
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2015)
Frequency of heartburn as measured by diary chart [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2015)
  • Intensity of hearburn as measured by visual analog scale [ Time Frame: 2 weeks ]
  • satisfaction as measured by questionnaire [ Time Frame: 2 weeks ]
  • quality of life as measured by questionnaire SF-8 [ Time Frame: 2 weeks ]
  • Number of participants with side effects [ Time Frame: 2 weeks ]
  • fetal outcomes as measured by birth weight and Apgar scores [ Time Frame: at birth ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alginate-based Reflux Suppressant and Magnesium-aluminium Antacid Gel for Treatment of Heartburn in Pregnancy
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heartburn in Pregnancy
Intervention  ICMJE
  • Drug: Alginate-based reflux suppressant
  • Drug: magnesium-aluminium antacid gel
Study Arms  ICMJE
  • Active Comparator: Alginate-based reflux suppressant
    Alginate-based reflux suppressant 15 ml oral every 6 hours for 2 weeks
    Intervention: Drug: Alginate-based reflux suppressant
  • Sham Comparator: magnesium-aluminium antacid gel
    magnesium-aluminium antacid gel 15 ml oral every 6 hours for 2 weeks
    Intervention: Drug: magnesium-aluminium antacid gel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02470117
Other Study ID Numbers  ICMJE 567/57
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vorapong Phupong, Chulalongkorn University
Study Sponsor  ICMJE Chulalongkorn University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Vorapong Phupong, M.D. Chulalongkorn University
PRS Account Chulalongkorn University
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP