Alginate-based Reflux Suppressant and Magnesium-aluminium Antacid Gel for Treatment of Heartburn in Pregnancy
NCT ID: NCT02470117
Last Updated: 2016-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2015-06-30
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Alginate-based reflux suppressant
Alginate-based reflux suppressant 15 ml oral every 6 hours for 2 weeks
Alginate-based reflux suppressant
magnesium-aluminium antacid gel
magnesium-aluminium antacid gel 15 ml oral every 6 hours for 2 weeks
magnesium-aluminium antacid gel
Interventions
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Alginate-based reflux suppressant
magnesium-aluminium antacid gel
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Allergic to alginate-based reflux suppressant and magnesium-aluminium antacid gel
18 Years
40 Years
FEMALE
Yes
Sponsors
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Chulalongkorn University
OTHER
Responsible Party
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Vorapong Phupong
Prof. Vorapong Phupong
Principal Investigators
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Vorapong Phupong, M.D.
Role: STUDY_DIRECTOR
Chulalongkorn University
Locations
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Vorapong Phupong
Bangkok, Bangkok, Thailand
Countries
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References
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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.
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.
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.
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.
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.
Quartarone G. Gastroesophageal reflux in pregnancy: a systematic review on the benefit of raft forming agents. Minerva Ginecol. 2013 Oct;65(5):541-9.
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.
Other Identifiers
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567/57
Identifier Type: -
Identifier Source: org_study_id
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