Clinical trial NCT01710462: Clinical Study, Multicenter, Randomized With 2 Arms of Pantoprazole + Domperidone and Pantoprazole Isolated at the 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Overall status: WITHDRAWN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: 2012-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This superiority phase III study to compare the combination of Pantoprazole and Domperidone with Pantoprazole isolated to the treatment of gastroesophageal reflux disease. The hypothesis is that combination of the two medication at the unique capsule is better to the patients because decrease the quantity of times the patients need to take medicines during the day.


Eligibility criteria: Inclusion Criteria:

1. Subscription of IC;
2. Age ≥ 18 years and \<70 years
3. Diagnosis initial clinical or previous symptomatic GERD;
4. Symptom score ≥ 4;
5. Ability to conduct examinations of endoscopy;
6. Ability to perform washout of drug classes PPIs, H2 antagonists, and prokinetics for at least 14 days.

Exclusion Criteria:

1. Presence of esophagitis requiring intervention, esophageal varices, Barrett's esophagus, scleroderma, ulcers (gastric or duodenal), atrophic gastritis, or vagotomy pangastritis detected at the time of study enrollment;
2. Eradication treatment of H. pylori completed less than 15 days of V0;
3. Presence of alarm symptoms (weight loss greater than 5% in the last 60 days, no evidence of gastrointestinal bleeding);
4. Gastric or esophageal surgery prior (except for simple ulcer closure);
5. Females in pregnancy, lactation, or who wish to become pregnant if they refuse to use adequate contraception during the study period.
6. Concomitant serious diseases such as kidney failure, heart and liver;
7. Suspected or confirmed any cancer except carcinoma in situ or nonmelanoma skin cancer diagnosed in the last 5 years;
8. History of gastric cancer in relatives of 1st degree;
9. Use of illicit drugs or alcohol abuse according to the investigator;
10. Values changed (outside the normal range for the local laboratory) in leukocytes, platelets or hemoglobin;
11. Significant changes in serum sodium, potassium, calcium or creatinine;
12. Intolerance or allergy to any component of the drugs evaluated in the study;
13. Use of anti-inflammatory drugs (NSAIDs), antiemetics, macrolides and systemic steroids for a period of not less than 2 weeks prior to the study or who have expected necessity of prolonged use during the study treatment;
14. Current use of bisphosphonates, as well as those who need calcium channel blockers or other drugs that affect esophageal motility or lower esophageal sphincter tone.
15. Use of other scheduled medications metabolized by cytochrome CYP3A4 during the study;
16. Participation recent (past 12 months) or participation in a clinical trial expected during this study in other clinical trials involving drugs of any kind.

Primary outcomes:
measure: Evaluate the efficacy of pantoprazole + domperidone Eurofarma at the treatment of gastroesophageal reflux disease in relation to the reference drug during 56 days using the score of symptoms
timeFrame: Evaluation at the gastroesophageal reflux disease in 56 treatment days
Secondary outcomes:
measure: Quality of life during the study treatment
timeFrame: Evaluation at the gastroesophageal reflux disease in 56 treatment days
measure: Endoscopic cure rate for patients with erosive gastroesophageal reflux disease
timeFrame: Evaluation at the gastroesophageal reflux disease in 56 treatment days
measure: Frequency of adverse events observed
timeFrame: Evaluation at the gastroesophageal reflux disease in 56 treatment days
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Goiania
state: Goias
city: Belo Horizonte
country: Brazil
facility: Belo Horizonte
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Curitiba
state: Paraná
city: Porto Alegre
country: Brazil
facility: Porto Alegre
state: Rio Grande do Sul
city: Campinas
country: Brazil
facility: Campinas
state: São Paulo
city: Jaú
country: Brazil
facility: Jaú
state: São Paulo
city: São José do Rio Preto
country: Brazil
facility: São José do Rio Preto
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Rio de Janeiro
Study officials:
References: