Phase
Condition
Esophageal Disorders
Gastroesophageal Reflux Disease (Gerd)
Heartburn (Pediatric)
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntary participation in the study with signature on Informed Consent Form (ICF)prior to specific protocol procedures
Patients of any race
On outpatient treatment
History of frequent symptom crises related to GERD within the last 3 months (at leasta frequency of twice a week, for about four to eight weeks)
Diagnosis of erosive esophagitis (grade A to D, according to Los AngelesClassification)
In good health condition, except GERD symptoms
Able to follow the protocol directions and to complete daily the questionnaireReQuest™ throughout the study
Exclusion
Exclusion Criteria:
Gastrointestinal disorder, even when related to chlorhydropeptic disorders: Barret'sesophagus, peptic ulcer, Zollinger-Ellison syndrome and pyloric stenosis
Previous history of surgery to reduce acid secretion, or other upper gastrointestinaltract surgeries (excepting polypectomy and cholecystectomy)
At initial endoscopy presenting complicated disorders due to erosive esophagitis:obstructive esophageal stenoses, Schatzki ring, esophageal diverticulum, esophagealvarices, achalasia and hiatal hernia
Pregnant women or during nursing period
Proton Pump Inhibitors (PPIs) within the last 10 days prior to start of the study
Triple therapy based on PPIs to eradicate H. pylori within the last 28 days prior tostart of the study
H2-blockers, sucralfate and prokinetics within the last 7 days prior to start of thestudy
Systemic glucocorticoids and/or nonsteroidal anti-inflammatory drugs (including COX-2inhibitors) for more than 3 consecutive days a week, within the last 28 days prior tostart of study, with exception of regular intake of acetyl salicylic acid in dosagesof up to 163 mg/day.
Study Design
Connect with a study center
Investigational site
Belo Horizonte/MG,
BrazilSite Not Available
Investigational site
Curitiba/PR,
BrazilSite Not Available
Investigational site
Goiânia/GO,
BrazilSite Not Available
Investigational site
Goiânia/GO,
BrazilSite Not Available
Investigational site
Porto Alegre/RS,
BrazilSite Not Available
Investigational site
Ribeirão Preto/SP,
BrazilSite Not Available
Investigational site
Ribeirão Preto/SP,
BrazilSite Not Available
Investigational site
Rio de Janeiro/RJ,
BrazilSite Not Available
Investigational site
Salvador/BA,
BrazilSite Not Available
Investigational site
Santo André/SP,
BrazilSite Not Available
Investigational site
Santo André/SP,
BrazilSite Not Available
Investigational site
São Paulo/SP,
BrazilSite Not Available
Investigational site
São Paulo/SP,
BrazilSite Not Available
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