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

Primary Purpose

Gastroesophageal Reflux Disease

Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Pantoprazole + Domperidone
Pantozol®
Sponsored by
Eurofarma Laboratorios S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Goiania
  • Belo Horizonte
  • Curitiba
  • Porto Alegre
  • Campinas
  • Jaú
  • São José do Rio Preto
  • Rio de Janeiro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pantoprazole + Domperidone

Pantozol® (Takeda)

Arm Description

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.

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.

Outcomes

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
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

Secondary Outcome Measures

Quality of life during the study treatment
Endoscopic cure rate for patients with erosive gastroesophageal reflux disease
Frequency of adverse events observed

Full Information

First Posted
October 15, 2012
Last Updated
July 23, 2015
Sponsor
Eurofarma Laboratorios S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01710462
Brief Title
Clinical Study, Multicenter, Randomized With 2 Arms of Pantoprazole + Domperidone and Pantoprazole Isolated at the Gastroesophageal Reflux Disease
Acronym
PANDA
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Change of company's strategy
Study Start Date
August 2013 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eurofarma Laboratorios S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pantoprazole + Domperidone
Arm Type
Experimental
Arm Description
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.
Arm Title
Pantozol® (Takeda)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pantoprazole + Domperidone
Intervention Type
Drug
Intervention Name(s)
Pantozol®
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
Evaluation at the gastroesophageal reflux disease in 56 treatment days
Secondary Outcome Measure Information:
Title
Quality of life during the study treatment
Time Frame
Evaluation at the gastroesophageal reflux disease in 56 treatment days
Title
Endoscopic cure rate for patients with erosive gastroesophageal reflux disease
Time Frame
Evaluation at the gastroesophageal reflux disease in 56 treatment days
Title
Frequency of adverse events observed
Time Frame
Evaluation at the gastroesophageal reflux disease in 56 treatment days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Goiania
City
Goiania
State/Province
Goias
Country
Brazil
Facility Name
Belo Horizonte
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
Facility Name
Curitiba
City
Curitiba
State/Province
Paraná
Country
Brazil
Facility Name
Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
Facility Name
Campinas
City
Campinas
State/Province
São Paulo
Country
Brazil
Facility Name
Jaú
City
Jaú
State/Province
São Paulo
Country
Brazil
Facility Name
São José do Rio Preto
City
São José do Rio Preto
State/Province
São Paulo
Country
Brazil
Facility Name
Rio de Janeiro
City
Rio de Janeiro
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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