Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg in Patients With Erosive Gastroesophageal Reflux Disease (PAMES 0109)
This study has been completed.
Sponsor:
Takeda
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01132638
First received: May 21, 2010
Last updated: June 24, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
GERD |
Drug: Magnesium Pantoprazole Drug: Magnesium Esomeprazole |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
GERD
Drug Information available for:
Magnesium
Omeprazole
Omeprazole magnesium
Pantoprazole
Esomeprazole
Pantoprazole sodium
Esomeprazole Sodium
Esomeprazole magnesium
U.S. FDA Resources
Further study details as provided by Takeda:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 713 |
| Study Start Date: | August 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Magnesium Pantoprazole |
Drug: Magnesium Pantoprazole
1 capsule daily, 40 mg, orally, 30 minutes before breakfast
|
| Active Comparator: Magnesium Esomeprazole |
Drug: Magnesium Esomeprazole
1 capsule daily, 40 mg, orally, 30 minutes before breakfast
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132638
Locations
| 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, Brazil | |
Sponsors and Collaborators
Takeda
More Information
No publications provided
| Responsible Party: | Takeda |
| ClinicalTrials.gov Identifier: | NCT01132638 History of Changes |
| Other Study ID Numbers: | PZ-9999-401-BR, U1111-1130-9255 |
| Study First Received: | May 21, 2010 |
| Last Updated: | June 24, 2012 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by Takeda:
|
Gastroesophageal Pantoprazole erosive Erosive GERD grades A-D, acc. to Los Angeles classification |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Omeprazole Pantoprazole |
Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Proton Pump Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013