Condition Measuring Alkaline Tide and Filling Symptoms' Questionnaire After Abrupt or Gradual Step Down Cessation of PPIPhase 1NCT01315444
Gastric Acid Rebound Secretion Measured by Alkaline Tide
A Phase 1 study testing Stop PPI gradually in people with Condition Measuring Alkaline Tide and Filling Symptoms' Questionnaire After Abrupt or Gradual Step Down Cessation of PPI, run by Rabin Medical Center.
Trial summary
Gastro esophageal reflux disease and ulcer related or non-ulcer dyspepsia, attacks 20% of the Western population. These millions of patients are treated continuously with PPI for different periods, many for many years. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Condition Measuring Alkaline Tide and Filling Symptoms' Questionnaire After Abrupt or Gradual Step Down Cessation of PPI
- What is being tested?
- Stop PPI gradually
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2016
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dyspepsia and reflux patients older than 18
Who cannot join
- patients on PPI, patients with severe diseases, younger than 18 y, older than 80 y, un-cooperative, COPD, uncompensated IHD, CRF
About this study
Official title: Gradual Cessation of Proton Pump Inhibitor (PPI) Treatment May Prevent Rebound Acid Secretion in Dyspeptic and Reflux Patients, Measured by the Alkaline Tide Method.
Gastro esophageal reflux disease and ulcer related or non-ulcer dyspepsia, attacks 20% of the Western population. These millions of patients are treated continuously with PPI for different periods, many for many years. Recently, rebound acid hypersecretion was recognized as a major clinical event after cessation of PPI therapy. Sustained hypergastrinemia due to daily PPI therapy causes increased acid-secretory capacity that appears when the drug is stopped. The transient increase in blood and urinary pH following gastric secretion has been termed the alkaline tide phenomenon. Carbonic acid, formed in the presence of the enzyme carbonic anhydrase, neutralizes intracellular hydroxyl ions produced as a result of luminal acid secretion. The bicarbonate generated is removed from the cell via the baso-lateral chloride bicarbonate exchanger. The investigators have shown in several studies that this phenomenon parallels acid secretion. Thus, stimulation of acid secretion with test meal increased base excess maximally after 45 minutes and these changes parallel peak acid output measured in gastric aspirate. The investigators hypothesize that gradual step down cessation of PPI will prevent this clinical relevant event. By measuring alkaline tide after PPI cessation the investigators may prove this hypothesis.
- Being tested
- Stop PPI gradually
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stop PPI graduallyDrug
Stop PPI graduallyDrug
| Study group | Role | What they receive |
|---|---|---|
| PPI abrupt cessation | Active comparator | Abrupt cessation Receives: Drug: Stop PPI gradually |
| PPI gradual step down cessation | Active comparator | Gradual cessation Receives: Drug: Stop PPI gradually |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of acid rebound phenomenon after stoping PPI
Comparing gradual and abrupt PPI cesation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condition Measuring Alkaline Tide and Filling Symptoms' Questionnaire After Abrupt or Gradual Step Down Cessation of PPIStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaron Niv, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315444
- Sponsor's protocol ID
- AT 101
- Other IDs
- RMC 101
- Status last verified
- Oct 2017
- First submitted
- 13 Mar 2011
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gradual Cessation of Proton Pump Inhibitor (PPI) Treatment May Prevent Rebound Acid Secretion in Dyspeptic and Reflux Patients, Measured by the Alkaline Tide Method.
- ClinicalTrials.gov ID
- NCT01315444
- Acronym / sponsor ID
- AT 101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Mar 2011 (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.
Gastro esophageal reflux disease and ulcer related or non-ulcer dyspepsia, attacks 20% of the Western population. These millions of patients are treated continuously with PPI for different periods, many for many years. Recently, rebound acid hypersecretion was recognized as a major clinical event after cessation of PPI therapy. Sustained hypergastrinemia due to daily PPI therapy causes increased acid-secretory capacity that appears when the drug is stopped. The transient increase in blood and urinary pH following gastric secretion has been termed the alkaline tide phenomenon. Carbonic acid, formed in the presence of the enzyme carbonic anhydrase, neutralizes intracellular hydroxyl ions produced as a result of luminal acid secretion. The bicarbonate generated is removed from the cell via the baso-lateral chloride bicarbonate exchanger. The investigators have shown in several studies that this phenomenon parallels acid secretion. Thus, stimulation of acid secretion with test meal increased base excess maximally after 45 minutes and these changes parallel peak acid output measured in gastric aspirate. The investigators hypothesize that gradual step down cessation of PPI will prevent this clinical relevant event. By measuring alkaline tide after PPI cessation the investigators may prove this hypothesis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPI abrupt cessation | Active comparator | Drug: Stop PPI graduallyAbrupt cessation |
| PPI gradual step down cessation | Active comparator | Drug: Stop PPI graduallyGradual cessation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dyspepsia and reflux patients older than 18
Key exclusion criteria (1 listed)
- patients on PPI, patients with severe diseases, younger than 18 y, older than 80 y, un-cooperative, COPD, uncompensated IHD, CRF
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 |
|---|---|---|
| Stop PPI gradually | Drug | PPI abrupt cessation |
| Stop PPI gradually | Drug | PPI gradual step down cessation |
Primary outcome
prevention of acid rebound phenomenon after stoping PPI
Time frame: 30 days
Comparing gradual and abrupt PPI cesation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stop PPI gradually in people with Condition Measuring Alkaline Tide and Filling Symptoms' Questionnaire After Abrupt or Gradual Step Down Cessation of PPI, run by Rabin Medical Center.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
prevention of acid rebound phenomenon after stoping PPI (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2017.