Stomach DiseasesPhase 4PROGRESSNCT02476097
PROGRESSive Withdrawal Esomeprazole and Acid-related Symptoms
A Phase 4 study testing Esomeprazole: Nexium® 20mg, Astra Zeneca and CYP2C19 phenotypical analysis in people with Stomach Diseases, run by Victoria Rollason at 2 sites in Switzerland.
Trial summary
Rebound acid hypersecretion (RAHS), defined as an increase in gastric acid secretion above pre-treatment levels after PPIs therapy is observed within two weeks after withdrawal of treatment and could theoretically lead to acid-related symptoms such as heartburn, acid regurgitation, or dyspepsia that might result in… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stomach Diseases
- What is being tested?
- Esomeprazole: Nexium® 20mg, Astra Zeneca and CYP2C19 phenotypical analysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jun 2015to Dec 2023
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment by esomeprazole 40mg since 4 weeks or more
- Esomeprazole withdrawal decided by the clinician
- Male and female aged 18-90 years
- Volunteers to participate to the study
- Must understand and read French language
- Must be able to give a written informed consent
Who cannot join
- Impairment of cognitive status
- Current indication to continue PPI treatment
- History of erosive and ulcerative esophagitis, Barrett esophagus, Zollinger-Ellison syndrome
- Short-term treatment of documented ulcer disease, as part of a combination regimen for Helicobacter pylori (HP) eradication
- Prevention of ulcers due to non-steroidal anti-inflammatory drugs.
- Hepatic impairment (TP<60%)
- Hypersensitivity to omeprazole (CYP2C19 activity) or esomeprazole
- Current pregnancy or current breastfeeding
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Service de de médecine interne et de rehabilitation, Beau-séjour, HUG
Geneva
Service de réadaptation de l'appareil locomoteur Clinique romande de réadaptation, Sion
Sion
About this study
Official title: Study of the Effect of PROGRESSive Withdrawal Esomeprazole of on Acid-related Symptoms, PROGRESS Study A Randomized, Placebo-controlled, Double Blinded Study
Rebound acid hypersecretion (RAHS), defined as an increase in gastric acid secretion above pre-treatment levels after PPIs therapy is observed within two weeks after withdrawal of treatment and could theoretically lead to acid-related symptoms such as heartburn, acid regurgitation, or dyspepsia that might result in resumption of therapy. A plausible physiologic theory for the rebound phenomenon suggests that long-term, elevated gastric pH caused by blockage of the proton-pumps stimulates compensatory gastrin release. Interestingly, Reimer et al. demonstrated the occurrence of RAHS in healthy volunteers who had received eight weeks of esomperazole. The clinical symptoms occured in a different prevalence compared with placebo treated patients at ten weeks after withdrawal and until the end of the study (twelve weeks). Twenty to twenty-two percent of patients displayed symptoms ten or twelve weeks after having discontinued PPIs while they occured in 1.7-7% of placebo-treated patients. Efforts should be pursued to restrict PPI therapy use to patients likely to benefit from it.
In this context, we propose to investigate the benefit of a progressive decrease in doses of esomeprazole compared to a sudden discontinuation. This is a randomized, double-blind, placebo-controlled trial with 156 patients treated by esomeprazole 40mg since four weeks least, randomized to one week of placebo or one week of esomeprazole 20mg. We want to compare the prevalence of clinical gastrointestinal symptoms between patients with progressive discontinuation (one week of esomeprazole, 20mg, then discontinuation) or those with sudden discontinuation of esomeprazole 40mg.
- Conditions
- Stomach Diseases
- Being tested
- Esomeprazole: Nexium® 20mg, Astra Zeneca, CYP2C19 phenotypical analysis, Placebo
- Keywords
- esomeprazole randomized study, proton pump inhibitor, gastric acid rebound, randomized study, esomeprazole
- Medical subject headings
- Stomach Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole: Nexium® 20mg, Astra ZenecaDrug
Also called Nexium®
Comparison of the prevalence of clinical symptoms of acid rebound, between patients with progressive (esomeprazole ) or sudden (placebo) discontinuation of Proton pump inhibitors.
CYP2C19 phenotypical analysisOther
Also called omeprazole 40mg
All patients included will undergo an assessment of the CYP2C19 activity by the administration of omeprazole 40mg and following measurement of omeprazole metabolic ratio respectively, once during the study.
PlaceboDrug
Comparison of the prevalence of clinical symptoms of acid rebound, between patients with progressive (esomeprazole ) or sudden (placebo) discontinuation of Proton pump inhibitors.
| Study group | Role | What they receive |
|---|---|---|
| Sudden discontinuation | Placebo comparator | placebo for 7 days Receives: Other: CYP2C19 phenotypical analysis; Drug: Placebo |
| Progressive discontinuation | Active comparator | Esomeprazole: Nexium® 20mg, Astra Zeneca , for 7 days Receives: Drug: Esomeprazole: Nexium® 20mg, Astra Zeneca; Other: CYP2C19 phenotypical analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportions of patients answering "yes" to the clinical gastrointestinal symptoms questions were comparable at visit 1.
The five-item PASS test is a valid tool for the evaluation of persistent acid-related symptoms in patients receiving PPI therapy. It demonstrates good content validity, test-retest reliability, responsiveness and construct validity in both English and French forms. The PASS test is a simple, clinically applicable tool for the identification of patients with persistent acid-related symptoms during therapy and the assessment of their responses to a change in therapy.
The investigators will modifiy the first question for the study. While, it is usually asked: " Are you taking prescription medication for any of the following stomach problems/symptoms:… " ; in the study, the investigators will ask : " Do you have any of the following stomach problems/symptoms : … ".
With any of the 7 symptoms, the patient will be considered as symptomatic.
Measured: day 8
The proportions of patients answering "yes" to the clinical gastrointestinal symptoms questions were comparable at visit 2.
The five-item PASS test is a valid tool for the evaluation of persistent acid-related symptoms in patients receiving PPI therapy. It demonstrates good content validity, test-retest reliability, responsiveness and construct validity in both English and French forms. The PASS test is a simple, clinically applicable tool for the identification of patients with persistent acid-related symptoms during therapy and the assessment of their responses to a change in therapy.
The investigators will modifiy the first question for the study. While, it is usually asked: " Are you taking prescription medication for any of the following stomach problems/symptoms:… " ; in the study, the investigators will ask : " Do you have any of the following stomach problems/symptoms : … ".
With any of the 7 symptoms, the patient will be considered as symptomatic.
Measured: day 15
The proportions of patients answering "yes" to the clinical gastrointestinal symptoms questions were comparable at visit 3.
The five-item PASS test is a valid tool for the evaluation of persistent acid-related symptoms in patients receiving PPI therapy. It demonstrates good content validity, test-retest reliability, responsiveness and construct validity in both English and French forms. The PASS test is a simple, clinically applicable tool for the identification of patients with persistent acid-related symptoms during therapy and the assessment of their responses to a change in therapy.
The investigators will modifiy the first question for the study. While, it is usually asked: " Are you taking prescription medication for any of the following stomach problems/symptoms:… " ; in the study, the investigators will ask : " Do you have any of the following stomach problems/symptoms : … ".
With any of the 7 symptoms, the patient will be considered as symptomatic.
Measured: day 22
The proportions of patients answering "yes" to the clinical gastrointestinal symptoms questions were comparable at visit 4.
The five-item PASS test is a valid tool for the evaluation of persistent acid-related symptoms in patients receiving PPI therapy. It demonstrates good content validity, test-retest reliability, responsiveness and construct validity in both English and French forms. The PASS test is a simple, clinically applicable tool for the identification of patients with persistent acid-related symptoms during therapy and the assessment of their responses to a change in therapy.
The investigators will modifiy the first question for the study. While, it is usually asked: " Are you taking prescription medication for any of the following stomach problems/symptoms:… " ; in the study, the investigators will ask : " Do you have any of the following stomach problems/symptoms : … ".
With any of the 7 symptoms, the patient will be considered as symptomatic.
Measured: day 29
Secondary outcomes (4)
The intensity of the acid rebound symptoms
The entire modified-PASS test will be evaluated with respect to patients' responses to the individual question; For each symptom, its severity will be measured and scored (minimum score 0: patient has no symptoms; maximum score 4: patient has symptoms requiring supplemental medications and affecting sleep, eating, drinking and daily activities).
The overall score will represent the consequence of the rebound acid symptoms.
Measured: day 8
The intensity of the acid rebound symptoms
The entire modified-PASS test will be evaluated with respect to patients' responses to the individual question; For each symptom, its severity will be measured and scored (minimum score 0: patient has no symptoms; maximum score 4: patient has symptoms requiring supplemental medications and affecting sleep, eating, drinking and daily activities).
The overall score will represent the consequence of the rebound acid symptoms.
Measured: day 15
The intensity of the acid rebound symptoms
The entire modified-PASS test will be evaluated with respect to patients' responses to the individual question; For each symptom, its severity will be measured and scored (minimum score 0: patient has no symptoms; maximum score 4: patient has symptoms requiring supplemental medications and affecting sleep, eating, drinking and daily activities).
The overall score will represent the consequence of the rebound acid symptoms.
Measured: day 22
The intensity of the acid rebound symptoms
The entire modified-PASS test will be evaluated with respect to patients' responses to the individual question; For each symptom, its severity will be measured and scored (minimum score 0: patient has no symptoms; maximum score 4: patient has symptoms requiring supplemental medications and affecting sleep, eating, drinking and daily activities).
The overall score will represent the consequence of the rebound acid symptoms.
Measured: day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stomach DiseasesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Victoria Rollason
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Victoria Rollason, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476097
- Sponsor's protocol ID
- 15-003
- Acronym
- PROGRESS
- Status last verified
- May 2023
- First submitted
- 15 Jun 2015
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Katz MH. Failing the acid test: benefits of proton pump inhibitors may not justify the risks for many users. Arch Intern Med. 2010 May 10;170(9):747-8. doi: 10.1001/archinternmed.2010.64. No abstract available.
PubMed 20458079Waldum HL, Arnestad JS, Brenna E, Eide I, Syversen U, Sandvik AK. Marked increase in gastric acid secretory capacity after omeprazole treatment. Gut. 1996 Nov;39(5):649-53. doi: 10.1136/gut.39.5.649.
PubMed 9026477Bjornsson E, Abrahamsson H, Simren M, Mattsson N, Jensen C, Agerforz P, Kilander A. Discontinuation of proton pump inhibitors in patients on long-term therapy: a double-blind, placebo-controlled trial. Aliment Pharmacol Ther. 2006 Sep 15;24(6):945-54. doi: 10.1111/j.1365-2036.2006.03084.x.
PubMed 16948806
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of PROGRESSive Withdrawal Esomeprazole of on Acid-related Symptoms, PROGRESS Study A Randomized, Placebo-controlled, Double Blinded Study
- ClinicalTrials.gov ID
- NCT02476097
- Acronym / sponsor ID
- PROGRESS / 15-003
- Conditions
- Stomach Diseases
- Keywords
- esomeprazole randomized study, proton pump inhibitor, gastric acid rebound, randomized study, esomeprazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Victoria RollasonUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 19 Jun 2015 (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.
Rebound acid hypersecretion (RAHS), defined as an increase in gastric acid secretion above pre-treatment levels after PPIs therapy is observed within two weeks after withdrawal of treatment and could theoretically lead to acid-related symptoms such as heartburn, acid regurgitation, or dyspepsia that might result in resumption of therapy. A plausible physiologic theory for the rebound phenomenon suggests that long-term, elevated gastric pH caused by blockage of the proton-pumps stimulates compensatory gastrin release. Interestingly, Reimer et al. demonstrated the occurrence of RAHS in healthy volunteers who had received eight weeks of esomperazole. The clinical symptoms occured in a different prevalence compared with placebo treated patients at ten weeks after withdrawal and until the end of the study (twelve weeks). Twenty to twenty-two percent of patients displayed symptoms ten or twelve weeks after having discontinued PPIs while they occured in 1.7-7% of placebo-treated patients. Efforts should be pursued to restrict PPI therapy use to patients likely to benefit from it.
In this context, we propose to investigate the benefit of a progressive decrease in doses of esomeprazole compared to a sudden discontinuation. This is a randomized, double-blind, placebo-controlled trial with 156 patients treated by esomeprazole 40mg since four weeks least, randomized to one week of placebo or one week of esomeprazole 20mg. We want to compare the prevalence of clinical gastrointestinal symptoms between patients with progressive discontinuation (one week of esomeprazole, 20mg, then discontinuation) or those with sudden discontinuation of esomeprazole 40mg.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sudden discontinuation | Placebo comparator | Other: CYP2C19 phenotypical analysis, Drug: Placeboplacebo for 7 days |
| Progressive discontinuation | Active comparator | Drug: Esomeprazole: Nexium® 20mg, Astra Zeneca, Other: CYP2C19 phenotypical analysisEsomeprazole: Nexium® 20mg, Astra Zeneca , for 7 days |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Treatment by esomeprazole 40mg since 4 weeks or more
- Esomeprazole withdrawal decided by the clinician
- Male and female aged 18-90 years
- Volunteers to participate to the study
- Must understand and read French language
Key exclusion criteria (8 listed)
- Impairment of cognitive status
- Current indication to continue PPI treatment
- History of erosive and ulcerative esophagitis, Barrett esophagus, Zollinger-Ellison syndrome
- Short-term treatment of documented ulcer disease, as part of a combination regimen for Helicobacter pylori (HP) eradication
- Prevention of ulcers due to non-steroidal anti-inflammatory drugs.
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 |
|---|---|---|
| Esomeprazole: Nexium® 20mg, Astra ZenecaAlso: Nexium®Comparison of the prevalence of clinical symptoms of acid rebound, between patients with progressive (esomeprazole ) or sudden (placebo) discontinuation of Proton pump inhibitors. | Drug | Progressive discontinuation |
| CYP2C19 phenotypical analysisAlso: omeprazole 40mgAll patients included will undergo an assessment of the CYP2C19 activity by the administration of omeprazole 40mg and following measurement of omeprazole metabolic ratio respectively, once during the study. | Other | Progressive discontinuation, Sudden discontinuation |
| PlaceboComparison of the prevalence of clinical symptoms of acid rebound, between patients with progressive (esomeprazole ) or sudden (placebo) discontinuation of Proton pump inhibitors. | Drug | Sudden discontinuation |
Primary outcome
The proportions of patients answering "yes" to the clinical gastrointestinal symptoms questions were comparable at visit 1.
Time frame: day 8
The five-item PASS test is a valid tool for the evaluation of persistent acid-related symptoms in patients receiving PPI therapy. It demonstrates good content validity, test-retest reliability, responsiveness and construct validity in both English and French forms. The PASS test is a simple, clinically applicable tool for the identification of patients with persistent acid-related symptoms during therapy and the assessment of their responses to a change in therapy. The investigators will modifiy the first question for the study. While, it is usually asked: " Are you taking prescription medication for any of the following stomach problems/symptoms:… " ; in the study, the investigators will ask : " Do you have any of the following stomach problems/symptoms : … ". With any of the 7 symptoms, the patient will be considered as symptomatic.
The proportions of patients answering "yes" to the clinical gastrointestinal symptoms questions were comparable at visit 2.
Time frame: day 15
The five-item PASS test is a valid tool for the evaluation of persistent acid-related symptoms in patients receiving PPI therapy. It demonstrates good content validity, test-retest reliability, responsiveness and construct validity in both English and French forms. The PASS test is a simple, clinically applicable tool for the identification of patients with persistent acid-related symptoms during therapy and the assessment of their responses to a change in therapy. The investigators will modifiy the first question for the study. While, it is usually asked: " Are you taking prescription medication for any of the following stomach problems/symptoms:… " ; in the study, the investigators will ask : " Do you have any of the following stomach problems/symptoms : … ". With any of the 7 symptoms, the patient will be considered as symptomatic.
The proportions of patients answering "yes" to the clinical gastrointestinal symptoms questions were comparable at visit 3.
Time frame: day 22
The five-item PASS test is a valid tool for the evaluation of persistent acid-related symptoms in patients receiving PPI therapy. It demonstrates good content validity, test-retest reliability, responsiveness and construct validity in both English and French forms. The PASS test is a simple, clinically applicable tool for the identification of patients with persistent acid-related symptoms during therapy and the assessment of their responses to a change in therapy. The investigators will modifiy the first question for the study. While, it is usually asked: " Are you taking prescription medication for any of the following stomach problems/symptoms:… " ; in the study, the investigators will ask : " Do you have any of the following stomach problems/symptoms : … ". With any of the 7 symptoms, the patient will be considered as symptomatic.
The proportions of patients answering "yes" to the clinical gastrointestinal symptoms questions were comparable at visit 4.
Time frame: day 29
The five-item PASS test is a valid tool for the evaluation of persistent acid-related symptoms in patients receiving PPI therapy. It demonstrates good content validity, test-retest reliability, responsiveness and construct validity in both English and French forms. The PASS test is a simple, clinically applicable tool for the identification of patients with persistent acid-related symptoms during therapy and the assessment of their responses to a change in therapy. The investigators will modifiy the first question for the study. While, it is usually asked: " Are you taking prescription medication for any of the following stomach problems/symptoms:… " ; in the study, the investigators will ask : " Do you have any of the following stomach problems/symptoms : … ". With any of the 7 symptoms, the patient will be considered as symptomatic.
4 secondary outcomes
The intensity of the acid rebound symptoms
Time frame: day 8
The intensity of the acid rebound symptoms
Time frame: day 15
The intensity of the acid rebound symptoms
Time frame: day 22
The intensity of the acid rebound symptoms
Time frame: day 29
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Results publication: PubMed 20458079Katz MH. Failing the acid test: benefits of proton pump inhibitors may not justify the risks for many users. Arch Intern Med. 2010 May 10;170(9):747-8. doi: 10.1001/archinternmed.2010.64. No abstract available.
- Results publication: PubMed 9026477Waldum HL, Arnestad JS, Brenna E, Eide I, Syversen U, Sandvik AK. Marked increase in gastric acid secretory capacity after omeprazole treatment. Gut. 1996 Nov;39(5):649-53. doi: 10.1136/gut.39.5.649.
- Results publication: PubMed 16948806Bjornsson E, Abrahamsson H, Simren M, Mattsson N, Jensen C, Agerforz P, Kilander A. Discontinuation of proton pump inhibitors in patients on long-term therapy: a double-blind, placebo-controlled trial. Aliment Pharmacol Ther. 2006 Sep 15;24(6):945-54. doi: 10.1111/j.1365-2036.2006.03084.x.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esomeprazole: Nexium® 20mg, Astra Zeneca and CYP2C19 phenotypical analysis in people with Stomach Diseases, run by Victoria Rollason at 2 sites in Switzerland.
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 6 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: status not confirmed, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The proportions of patients answering "yes" to the clinical gastrointestinal symptoms questions were comparable at visit 1. (time frame: day 8). The study lists 4 primary outcomes in all. 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 NCT02476097, which also lists 3 linked publications.
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 May 2023.