Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg in Patients With Erosive Gastroesophageal Reflux Disease

GERD Clinical Trial

— PAMES 0109  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01132638
• Other study ID #: PZ-9999-401-BR
• Secondary ID: U1111-1130-9255
• Status: Completed
• Phase: Phase 3
• First received: May 21, 2010
• Last updated: June 24, 2012
• Start date: August 2011
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 713
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD

Intervention

Drug:
• Magnesium Pantoprazole
1 capsule daily, 40 mg, orally, 30 minutes before breakfast
• Magnesium Esomeprazole
1 capsule daily, 40 mg, orally, 30 minutes before breakfast

Locations

Country	Name	City	State
Brazil	Investigational site	Belo Horizonte/MG
Brazil	Investigational site	Curitiba/PR
Brazil	Investigational site	Goiânia/GO
Brazil	Investigational site	Porto Alegre/RS
Brazil	Investigational site	Ribeirão Preto/SP
Brazil	Investigational site	Rio de Janeiro/RJ
Brazil	Investigational site	Salvador/BA
Brazil	Investigational site	Santo André/SP
Brazil	Investigational site	São Paulo/SP

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	After 4 treatment weeks	No
Secondary	Treatments comparative evaluation for DRGE ReQuest™-GI and -WSO scores change with respect to baseline measured		After 4 and 8 treatment weeks	No
Secondary	Treatments comparative evaluation for the time interval from treatment start to the beginning of symptoms relief			No
Secondary	Treatments comparative evaluation for endoscopic healing rate		After 4 and 8 treatment weeks	No