Clinical Study, Multicenter, Randomized With 2 Arms of Pantoprazole + Domperidone and Pantoprazole Isolated at the Gastroesophageal Reflux Disease

NCT ID: NCT01710462

Last Updated: 2015-07-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31

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.

Conditions

Gastroesophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pantoprazole + Domperidone

The combination of pantoprazole and domperidone provided for the study will be the new incremental formulation produced by Eurofarma. For this study will be used doses of capsules containing 20 mg pantoprazole, 20 mg of domperidone.

Group Type: EXPERIMENTAL

Pantoprazole + Domperidone

Intervention Type: DRUG

Pantozol® (Takeda)

The Pantozol® may be presented in boxes of coated tablets of 20 mg or 40 mg. For this study will be used 20 mg tablets.

Group Type: ACTIVE_COMPARATOR

Pantozol®

Intervention Type: DRUG

Interventions

Pantoprazole + Domperidone

Intervention Type: DRUG

Pantozol®

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Goiania

Goiânia, Goiás, Brazil

Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Curitiba

Curitiba, Paraná, Brazil

Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Campinas

Campinas, São Paulo, Brazil

Jaú

Jaú, São Paulo, Brazil

São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Countries

Brazil

Other Identifiers

EF129

Identifier Type: -

Identifier Source: org_study_id