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

NCT01710462 | Withdrawn Phase 3

• 1 other identifier: EF129
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 8

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Pantoprazole + Domperidone

EXPERIMENTAL

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

Pantozol® (Takeda)

ACTIVE COMPARATOR

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®

Interventions

Pantoprazole + Domperidone DRUG

Pantoprazole + Domperidone

Pantozol® DRUG

Pantozol® (Takeda)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (8)

Goiania

Goiânia, Goiás, Brazil

Location

Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Location

Curitiba

Curitiba, Paraná, Brazil

Location

Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Campinas

Campinas, São Paulo, Brazil

Location

Jaú

Jaú, São Paulo, Brazil

Location

São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Pantoprazole; Domperidone

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperidines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: October 19, 2012
• Study Start: August 1, 2013
• Last Updated: July 24, 2015

Record last verified: 2012-10

Locations

BR (8)