Heartburn in Pregnancy Clinical Trial
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
| Verified date | July 2016 |
| Source | Chulalongkorn University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Thailand: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | July 2016 |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 40 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Vorapong Phupong | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| Chulalongkorn University |
Thailand,
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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. Erratum in: Am J Gastroenterol. 2013 Oct;108(10):1672. — View Citation
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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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Frequency of heartburn as measured by diary chart | 2 weeks | No | |
| Secondary | Intensity of hearburn as measured by visual analog scale | 2 weeks | No | |
| Secondary | satisfaction as measured by questionnaire | 2 weeks | No | |
| Secondary | quality of life as measured by questionnaire SF-8 | 2 weeks | No | |
| Secondary | Number of participants with side effects | 2 weeks | No | |
| Secondary | fetal outcomes as measured by birth weight and Apgar scores | at birth | No |