GERDPhase 3PAMES 0109NCT01132638
Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg in Patients With Erosive Gastroesophageal Reflux Disease
A Phase 3 study testing Magnesium Pantoprazole and Magnesium Esomeprazole in people with GERD, run by Takeda at 9 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- GERD
- What is being tested?
- Magnesium Pantoprazole and Magnesium Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 713 participants
- Where
- 9 sitesBrazil
- Study dates
- Aug 2011to Jun 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Brazil9 sites
Investigational site
Belo Horizonte/MG
Investigational site
Curitiba/PR
Investigational site
Goiânia/GO
Investigational site
Porto Alegre/RS
Investigational site
Ribeirão Preto/SP
Investigational site
Rio de Janeiro/RJ
Investigational site
Salvador/BA
Investigational site
Santo André/SP
Investigational site
São Paulo/SP
About this study
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
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.
- Conditions
- GERD
- Being tested
- Magnesium Pantoprazole, Magnesium Esomeprazole
- Keywords
- Gastroesophageal, Pantoprazole, erosive, Erosive GERD grades A-D, acc. to Los Angeles classification
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium PantoprazoleDrug
1 capsule daily, 40 mg, orally, 30 minutes before breakfast
Magnesium EsomeprazoleDrug
1 capsule daily, 40 mg, orally, 30 minutes before breakfast
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Pantoprazole | Active comparator | Not described Receives: Drug: Magnesium Pantoprazole |
| Magnesium Esomeprazole | Active comparator | Not described Receives: Drug: Magnesium Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 4 treatment weeks
Secondary outcomes (3)
Treatments comparative evaluation for DRGE ReQuest™-GI and -WSO scores change with respect to baseline measured
Measured: After 4 and 8 treatment weeks
Treatments comparative evaluation for the time interval from treatment start to the beginning of symptoms relief
Treatments comparative evaluation for endoscopic healing rate
Measured: After 4 and 8 treatment weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 713 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132638
- Sponsor's protocol ID
- PZ-9999-401-BR
- Other IDs
- U1111-1130-9255
- Acronym
- PAMES 0109
- Status last verified
- Jun 2012
- First submitted
- 21 May 2010
- Last updated
- 26 Jun 2012
- Results posted
- No
Publications
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.
PubMed 24299323
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01132638
- Acronym / sponsor ID
- PAMES 0109 / PZ-9999-401-BR
- Conditions
- GERD
- Keywords
- Gastroesophageal, Pantoprazole, erosive, Erosive GERD grades A-D, acc. to Los Angeles classification
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 713 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 28 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Pantoprazole | Active comparator | Drug: Magnesium Pantoprazole |
| Magnesium Esomeprazole | Active comparator | Drug: Magnesium Esomeprazole |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Pantoprazole1 capsule daily, 40 mg, orally, 30 minutes before breakfast | Drug | Magnesium Pantoprazole |
| Magnesium Esomeprazole1 capsule daily, 40 mg, orally, 30 minutes before breakfast | Drug | Magnesium Esomeprazole |
Primary outcome
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
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.
3 secondary outcomes
Treatments comparative evaluation for DRGE ReQuest™-GI and -WSO scores change with respect to baseline measured
Time frame: After 4 and 8 treatment weeks
Treatments comparative evaluation for the time interval from treatment start to the beginning of symptoms relief
Treatments comparative evaluation for endoscopic healing rate
Time frame: After 4 and 8 treatment weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
- Derived from this study: PubMed 24299323Moraes-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Magnesium Pantoprazole and Magnesium Esomeprazole in people with GERD, run by Takeda at 9 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01132638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2012.