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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Gastroesophageal Reflux Disease
Intervention	Drug: Pantoprazole + Domperidone Drug: Pantozol®
Phase	Phase 3
Sponsor	Eurofarma Laboratorios S.A.
Responsible Party	Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier	NCT01710462
First Received	October 15, 2012
Last Updated	October 17, 2012
Last verified	October 2012

Tracking Information[ + expand ][ + ]

First Received Date	October 15, 2012
Last Updated Date	October 17, 2012
Start Date	August 2013
Estimated Primary Completion Date	October 2014
Current Primary Outcome Measures	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 [Time Frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days] [Designated as safety issue: Yes]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
Current Secondary Outcome Measures	Quality of life during the study treatment [Time Frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days] [Designated as safety issue: Yes] Endoscopic cure rate for patients with erosive gastroesophageal reflux disease [Time Frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days] [Designated as safety issue: Yes] Frequency of adverse events observed [Time Frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Clinical Study, Multicenter, Randomized With 2 Arms of Pantoprazole + Domperidone and Pantoprazole Isolated at the Gastroesophageal Reflux Disease
Official Title	Not Provided
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Condition	Gastroesophageal Reflux Disease
Intervention	Drug: Pantoprazole + Domperidone Drug: Pantozol®
Study Arm (s)	Experimental: 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. Active Comparator: 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.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Not yet recruiting
Estimated Enrollment	292
Estimated Completion Date	October 2014
Estimated Primary Completion Date	September 2014
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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Suely K Inoue, Pharm D +55 11 4144 9662 suely.inoue@eurofarma.com.br
Location Countries	Brazil

Administrative Information[ + expand ][ + ]

NCT Number	NCT01710462
Other Study ID Numbers	EF129
Has Data Monitoring Committee	No
Information Provided By	Eurofarma Laboratorios S.A.
Study Sponsor	Eurofarma Laboratorios S.A.
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	October 2012

Locations[ + expand ][ + ]

Goiania	Goiania, Goias, Brazil Not yet recruiting
Belo Horizonte	Belo Horizonte, Minas Gerais, Brazil Not yet recruiting
Curitiba	Curitiba, Paraná, Brazil Not yet recruiting
Porto Alegre	Porto Alegre, Rio Grande do Sul, Brazil Not yet recruiting
Campinas	Campinas, São Paulo, Brazil Not yet recruiting
Jaú	Jaú, São Paulo, Brazil Not yet recruiting
São José do Rio Preto	São José do Rio Preto, São Paulo, Brazil Not yet recruiting
Rio de Janeiro	Rio de Janeiro, Brazil Not yet recruiting