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

Gastroesophageal Reflux Disease Clinical Trial

— PANDA  

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01710462
• Other study ID #: EF129
• Status: Withdrawn
• Phase: Phase 3
• First received: October 15, 2012
• Last updated: July 23, 2015
• Start date: August 2013

Study information

• Verified date: October 2012
• Source: Eurofarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Pantoprazole + Domperidone

• Pantozol®

Locations

Country	Name	City	State
Brazil	Belo Horizonte	Belo Horizonte	Minas Gerais
Brazil	Campinas	Campinas	São Paulo
Brazil	Curitiba	Curitiba	Paraná
Brazil	Goiania	Goiania	Goias
Brazil	Jaú	Jaú	São Paulo
Brazil	Porto Alegre	Porto Alegre	Rio Grande do Sul
Brazil	Rio de Janeiro	Rio de Janeiro
Brazil	São José do Rio Preto	São José do Rio Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Quality of life during the study treatment		Evaluation at the gastroesophageal reflux disease in 56 treatment days	Yes
Secondary	Endoscopic cure rate for patients with erosive gastroesophageal reflux disease		Evaluation at the gastroesophageal reflux disease in 56 treatment days	Yes
Secondary	Frequency of adverse events observed		Evaluation at the gastroesophageal reflux disease in 56 treatment days	Yes