Clinical trial NCT01132638: Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg in Patients With Erosive Gastroesophageal Reflux Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: GERD
Keywords: Gastroesophageal
Pantoprazole
erosive
Erosive GERD grades A-D, acc. to Los Angeles classification
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-05-28
Enrollment: 713
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: After 4 treatment weeks
Secondary outcomes:
measure: Treatments comparative evaluation for DRGE ReQuest™-GI and -WSO scores change with respect to baseline measured
timeFrame: After 4 and 8 treatment weeks
measure: Treatments comparative evaluation for the time interval from treatment start to the beginning of symptoms relief
measure: Treatments comparative evaluation for endoscopic healing rate
timeFrame: After 4 and 8 treatment weeks
Other outcomes:
Locations:
city: Belo Horizonte/MG
country: Brazil
facility: Investigational site
city: Curitiba/PR
country: Brazil
facility: Investigational site
city: Goiânia/GO
country: Brazil
facility: Investigational site
city: Porto Alegre/RS
country: Brazil
facility: Investigational site
city: Ribeirão Preto/SP
country: Brazil
facility: Investigational site
city: Rio de Janeiro/RJ
country: Brazil
facility: Investigational site
city: Salvador/BA
country: Brazil
facility: Investigational site
city: Santo André/SP
country: Brazil
facility: Investigational site
city: São Paulo/SP
country: Brazil
facility: Investigational site
Study officials:
References:
citation: 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.