CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 80 enrolled
Drug / intervention
Alginic acid +3 moredrug
Likely dose
Domperidone 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01878526
NCT01878526Phase 3Completed
CompareCT.gov

The Effectiveness of Domperidone Versus Alginic Acid Add on Omeprazole Therapy in Omeprazole Resistance Gastroesophageal Reflux in Systemic Sclerosis

Khon Kaen University·interventional·Posted Jun 17, 2013·Updated Mar 27, 2017

In Brief

A Phase 3 clinical trial evaluating Alginic acid, placebo (for domperidone), and 2 other interventions for Gastroesophageal Reflux Disease and 2 related conditions. Completed, enrolled 80 participants across 1 site.

Detailed Summary

The investigators purposes are to define the prevalence of omeprazole resistance gastroesophageal reflux disease (GERD) in systemic sclerosis (SSc), to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the severity of reflux symptoms in omeprazole resistant GERD in SSc, and to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the frequency of symptoms in omeprazole- resistant GERD in SSc.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux Disease, Systemic Sclerosis, Scleroderma
CountriesThailand
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 17, 2013
Enrollment StartJun 1, 2013
Primary CompletionAug 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 13.0 years ago

Interventions

Alginic aciddrug

Algycon 1 tab chew tid after meal

placebo (for domperidone)drug

placebo (for domperidone) 1 tab oral tid before meal

Domperidonedrug

domperidone (10 mg) 1 tab oral tid before meal

placebo (of alginic acid)drug

placebo (for alginic acid) 1 tab chew tid after meal