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WithdrawnNCT01710462PANDAUpdated Jul 24, 2015

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

A Phase 3 interventional study of Pantoprazole + Domperidone and Pantozol® in Gastroesophageal Reflux Disease, sponsored by Eurofarma Laboratorios S.A.. Withdrawn at 8 sites in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-07-24.

Sponsored by Eurofarma Laboratorios S.A. · Phase 3, Interventional, and Treatment

Why this study was withdrawn
Change of company's strategy
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Gastroesophageal Reflux Disease
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In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Eurofarma Laboratorios S.A. is the lead sponsor of 64 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
0 participants (actual)

Study arms

  • 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.

    Drug: Pantoprazole + 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.

    Drug: Pantozol®

Interventions

  • DrugPantoprazole + Domperidone
  • DrugPantozol®
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What researchers measure

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

    Time frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days

Secondary outcomes

  1. Quality of life during the study treatment

    Time frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days

  2. Endoscopic cure rate for patients with erosive gastroesophageal reflux disease

    Time frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days

  3. Frequency of adverse events observed

    Time frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days

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Study locations

8 sites
  • Goiania
    Goiania, Goias, Brazil
  • Belo Horizonte
    Belo Horizonte, Minas Gerais, Brazil
  • Curitiba
    Curitiba, Paraná, Brazil
  • Porto Alegre
    Porto Alegre, Rio Grande do Sul, Brazil
  • Campinas
    Campinas, São Paulo, Brazil
  • Jaú
    Jaú, São Paulo, Brazil
  • São José do Rio Preto
    São José do Rio Preto, São Paulo, Brazil
  • Rio de Janeiro
    Rio de Janeiro, Brazil
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01710462
Lead sponsor
Eurofarma Laboratorios S.A.
Responsible party
Sponsor
First posted
Oct 19, 2012
Start date
Aug 2013
Last update
Jul 24, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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