Phase
Condition
Gastroesophageal Reflux Disease (Gerd)
Esophageal Disorders
Heartburn (Pediatric)
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subscription of IC;
Age ≥ 18 years and <70 years
Diagnosis initial clinical or previous symptomatic GERD;
Symptom score ≥ 4;
Ability to conduct examinations of endoscopy;
Ability to perform washout of drug classes PPIs, H2 antagonists, and prokinetics forat least 14 days.
Exclusion
Exclusion Criteria:
Presence of esophagitis requiring intervention, esophageal varices, Barrett'sesophagus, scleroderma, ulcers (gastric or duodenal), atrophic gastritis, or vagotomypangastritis detected at the time of study enrollment;
Eradication treatment of H. pylori completed less than 15 days of V0;
Presence of alarm symptoms (weight loss greater than 5% in the last 60 days, noevidence of gastrointestinal bleeding);
Gastric or esophageal surgery prior (except for simple ulcer closure);
Females in pregnancy, lactation, or who wish to become pregnant if they refuse to useadequate contraception during the study period.
Concomitant serious diseases such as kidney failure, heart and liver;
Suspected or confirmed any cancer except carcinoma in situ or nonmelanoma skin cancerdiagnosed in the last 5 years;
History of gastric cancer in relatives of 1st degree;
Use of illicit drugs or alcohol abuse according to the investigator;
Values changed (outside the normal range for the local laboratory) in leukocytes,platelets or hemoglobin;
Significant changes in serum sodium, potassium, calcium or creatinine;
Intolerance or allergy to any component of the drugs evaluated in the study;
Use of anti-inflammatory drugs (NSAIDs), antiemetics, macrolides and systemic steroidsfor a period of not less than 2 weeks prior to the study or who have expectednecessity of prolonged use during the study treatment;
Current use of bisphosphonates, as well as those who need calcium channel blockers orother drugs that affect esophageal motility or lower esophageal sphincter tone.
Use of other scheduled medications metabolized by cytochrome CYP3A4 during the study;
Participation recent (past 12 months) or participation in a clinical trial expectedduring this study in other clinical trials involving drugs of any kind.
Study Design
Connect with a study center
Goiania
Goiania, Goias
BrazilSite Not Available
Belo Horizonte
Belo Horizonte, Minas Gerais
BrazilSite Not Available
Curitiba
Curitiba, Paraná
BrazilSite Not Available
Porto Alegre
Porto Alegre, Rio Grande do Sul
BrazilSite Not Available
Campinas
Campinas, São Paulo
BrazilSite Not Available
Jaú
Jaú, São Paulo
BrazilSite Not Available
São José do Rio Preto
São José do Rio Preto, São Paulo
BrazilSite Not Available
Rio de Janeiro
Rio de Janeiro,
BrazilSite Not Available

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