Clinical trial NCT01471925: Study Comparing Esomeprazole Associated With Sodium Bicarbonate From Eurofarma and Esomeprazole in Treatment of Gastroesophageal Reflux Disease ESOBIC
Official title: A Phase III, Randomized, Open-label, Superiority Study Comparing the Incremental Product Esomeprazole Associated With Sodium Bicarbonate Made by Eurofarma and Nexium® in the Treatment of Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2011-11-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phase III, randomized, open-label, superiority study comparing the incremental product esomeprazole associated with sodium bicarbonate made by Eurofarma and Nexium® in the treatment of gastroesophageal reflux disease. The study will enroll 94 patients in each arm (total of 188 patients).


Eligibility criteria: Inclusion Criteria:

ICF signing;

* Age ≥ 18 years;
* Gastroesophageal reflux disease diagnosis;
* Grade 0 to grade III reflux esophagitis, assessed by means of upper gastrointestinal endoscopy;
* Ability to have the endoscopy, pH-metry and esophageal manometry examinations performed;
* Washout period of 1 week without using PPI, H2 antagonists and prokinetic agents and of at least 1 day without using antacids.

Exclusion Criteria:

* Presence of esophagitis requiring intervention (grade IV), esophageal varices, Barrett's esophagus, systemic sclerosis or ulcers (gastric or duodenal ulcers);
* Previous gastric or esophageal surgery;
* Dietary sodium restriction, metabolic alkalosis, hypokalemia, Barter syndrome; Pregnancy or breastfeeding;
* Concomitant diseases, such as kidney, liver and heart failure;
* Suspected or confirmed cancer of any type;
* Abusive drug or alcohol use;
* Abnormal values for white blood cells, platelets or hemoglobin;
* Significant changes in serum sodium, potassium, calcium or creatinine concentrations;
* Treatment with PPI, H2 antagonists or prokinetic agents that may not be withheld during the washout period of 1 week or during the study;
* Intolerance or allergy to any of the components in the drug products assessed in the study;
* Use of nonsteroidal anti-inflammatory drugs (NSAIDs), antiemetic agents, macrolide antibiotics and systemic corticoids for a period equal to or greater than 2 weeks before the study or that is expected to require prolonged use during study treatment;
* Concomitant use or requirement of a gastric pH-dependent medication for optimal absorption;
* Scheduled use of other medications metabolized by cytochrome CYP during the study;
* History of active peptic ulcer;
* Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency;
* Recent participation (within the last 12 months) in another clinical study.

Primary outcomes:
measure: Efficacy
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Instituto Goiano de Gastroenterologia
state: GO
city: Porto Alegre
country: Brazil
facility: Mãe de Deus Center
state: Rio Grande do Sul
city: Rio de janeiro
country: Brazil
facility: Centro de pesquisa Clínica do Serviço de gastroenterologia
state: RJ
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
state: SP
city: Canpinas
country: Brazil
facility: Centro de Pesquisa Clínica de Campinas
state: São Paulo
city: Jaú
country: Brazil
facility: Centro de Estudos Clínicos do Interior Paulista
state: São Paulo
Study officials:
References: