Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg in Patients With Erosive Gastroesophageal Reflux Disease (PAMES 0109)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01132638
First received: May 21, 2010
Last updated: June 24, 2012
Last verified: June 2012

May 21, 2010
June 24, 2012
August 2011
June 2012   (final data collection date for primary outcome measure)
Comparatively evaluation of the clinical efficacy of pantoprazole magnesium and esomeprazole in the treatment of patients with erosive gastroesophageal reflux disease (GERD), considering the proportion of patients in complete remission. [ Time Frame: After 4 treatment weeks ] [ Designated as safety issue: No ]
A patient is considered at complete remission if he/she achieved symptoms relief and confirmed endoscopic healing at treatment end. A patient achieves symptoms relief if Reflux Questionnaire-GI score ((ReQuest™) stays below 1,73 for at least the three last consecutive treatment days, that can occur at visit V2 or visit V3 for those that did not achieve complete remission at V2 and repeated the treatment for 4 weeks more.
Same as current
Complete list of historical versions of study NCT01132638 on ClinicalTrials.gov Archive Site
  • Treatments comparative evaluation for DRGE ReQuest™-GI and -WSO scores change with respect to baseline measured [ Time Frame: After 4 and 8 treatment weeks ] [ Designated as safety issue: No ]
  • Treatments comparative evaluation for the time interval from treatment start to the beginning of symptoms relief [ Designated as safety issue: No ]
  • Treatments comparative evaluation for endoscopic healing rate [ Time Frame: After 4 and 8 treatment weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg in Patients With Erosive Gastroesophageal Reflux Disease
Evaluation of Complete Remission of Erosive Gastroesophageal Reflux Disease Following Four-week Treatment With Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg With Eight-week Extension Treatment in Non-responding Patients - Multicenter, National, Prospective, Randomized, Double-blind, Parallel-group, Phase III

The aim of this trial is to evaluate the complete remission of erosive gastroesophageal reflux disease with pantoprazole magnesium 40 mg once daily versus esomeprazole 40 mg once daily during four-week treatment with an extension treatment for non-responding patients. The study includes a baseline period up to 14 days and a treatment period of either 4 weeks (28 -2 + 5 days), or 8 weeks depending on the cure of esophagitis due to gastroesophageal reflux. The study will provide further data on safety and tolerability of pantoprazole magnesium.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
GERD
  • Drug: Magnesium Pantoprazole
    1 capsule daily, 40 mg, orally, 30 minutes before breakfast
  • Drug: Magnesium Esomeprazole
    1 capsule daily, 40 mg, orally, 30 minutes before breakfast
  • Active Comparator: Magnesium Pantoprazole
    Intervention: Drug: Magnesium Pantoprazole
  • Active Comparator: Magnesium Esomeprazole
    Intervention: Drug: Magnesium Esomeprazole
Moraes-Filho JP, Pedroso M, Quigley EM; PAMES Study Group. Randomised clinical trial: daily pantoprazole magnesium 40 mg vs. esomeprazole 40 mg for gastro-oesophageal reflux disease, assessed by endoscopy and symptoms. Aliment Pharmacol Ther. 2014 Jan;39(1):47-56. doi: 10.1111/apt.12540. Epub 2013 Oct 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
713
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Voluntary participation in the study with signature on Informed Consent Form (ICF) prior to specific protocol procedures
  • Patients of any race
  • On outpatient treatment
  • History of frequent symptom crises related to GERD within the last 3 months (at least a frequency of twice a week, for about four to eight weeks)
  • Diagnosis of erosive esophagitis (grade A to D, according to Los Angeles Classification)
  • In good health condition, except GERD symptoms
  • Able to follow the protocol directions and to complete daily the questionnaire ReQuest™ throughout the study

Exclusion Criteria:

  • Gastrointestinal disorder, even when related to chlorhydropeptic disorders: Barret's esophagus, peptic ulcer, Zollinger-Ellison syndrome and pyloric stenosis
  • Previous history of surgery to reduce acid secretion, or other upper gastrointestinal tract surgeries (excepting polypectomy and cholecystectomy)
  • At initial endoscopy presenting complicated disorders due to erosive esophagitis: obstructive esophageal stenoses, Schatzki ring, esophageal diverticulum, esophageal varices, achalasia and hiatal hernia
  • Pregnant women or during nursing period
  • Proton Pump Inhibitors (PPIs) within the last 10 days prior to start of the study
  • Triple therapy based on PPIs to eradicate H. pylori within the last 28 days prior to start of the study
  • H2-blockers, sucralfate and prokinetics within the last 7 days prior to start of the study
  • Systemic glucocorticoids and/or nonsteroidal anti-inflammatory drugs (including COX-2 inhibitors) for more than 3 consecutive days a week, within the last 28 days prior to start of study, with exception of regular intake of acetyl salicylic acid in dosages of up to 163 mg/day.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01132638
PZ-9999-401-BR, U1111-1130-9255
Not Provided
Takeda
Takeda
Not Provided
Not Provided
Takeda
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP