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Gastroesophageal Reflux Treatment in Scleroderma

NCT01878526 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-03-27

Study results available
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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.

Conditions

Interventions

DRUG

Alginic acid

Algycon 1 tab chew tid after meal

DRUG

placebo (for domperidone)

placebo (for domperidone) 1 tab oral tid before meal

DRUG

Domperidone

domperidone (10 mg) 1 tab oral tid before meal

DRUG

placebo (of alginic acid)

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

Sponsors & Collaborators

  • Khon Kaen University

    lead OTHER

Principal Investigators

  • Chingching Foocharoen, MD · Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-08-31
Completion
2016-01-31

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01878526 on ClinicalTrials.gov