Clinical trial NCT02470117: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heartburn in Pregnancy
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2015-06-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Frequency of heartburn as measured by diary chart
timeFrame: 2 weeks
Secondary outcomes:
measure: Intensity of hearburn as measured by visual analog scale
timeFrame: 2 weeks
measure: satisfaction as measured by questionnaire
timeFrame: 2 weeks
measure: quality of life as measured by questionnaire SF-8
timeFrame: 2 weeks
measure: Number of participants with side effects
timeFrame: 2 weeks
measure: fetal outcomes as measured by birth weight and Apgar scores
timeFrame: at birth
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Vorapong Phupong
Study officials:
affiliation: Chulalongkorn University
name: Vorapong Phupong, M.D.
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.