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

Study Overview
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Brief Summary
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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
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: Pantoprazole + Domperidone
* Drug: Pantozol®


Participation Criteria
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Eligibility Criteria
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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 for at least 14 days. Exclusion Criteria: 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; 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, no evidence 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 use adequate 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 cancer diagnosed 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 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; 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. Use of other scheduled medications metabolized by cytochrome CYP3A4 during the study; Participation recent (past 12 months) or participation in a clinical trial expected during this study in other clinical trials involving drugs of any kind.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pantoprazole + Domperidone<br>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. | Drug: Pantoprazole + Domperidone<br> <br> |
| Active Comparator: Pantozol® (Takeda)<br>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. | Drug: Pantozol®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The primary objective of the study is to evaluate the efficacy of combining incremental pantoprazole and domperidone Eurofarma the treatment of gastroesophageal reflux disease in relation to the reference drug. The primary endpoint is the score of symptoms (heartburn and regurgitation) including the severity and frequency after treatment | Evaluation at the gastroesophageal reflux disease in 56 treatment days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life during the study treatment |  | Evaluation at the gastroesophageal reflux disease in 56 treatment days | 
| Endoscopic cure rate for patients with erosive gastroesophageal reflux disease |  | Evaluation at the gastroesophageal reflux disease in 56 treatment days | 
| Frequency of adverse events observed |  | Evaluation at the gastroesophageal reflux disease in 56 treatment days |