Gastroesophageal Reflux DiseasePhase 4NCT02401035
PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects
A Phase 4 study testing IV pantoprazole in people with Gastroesophageal Reflux Disease, run by Pfizer at 19 sites in 9 countries.
Trial summary
The purpose of this study is to characterize the pharmacokinetics (PK) and safety of intravenous (IV) pantoprazole in patients 1 to 16 years old who are candidates for acid suppression therapy. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- IV pantoprazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 19 sitesin 9 countries
- Study dates
- 9 May 2017to 18 Jun 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects aged 1 to 16 years who in the judgment of the investigator are candidates for gastric acid suppression therapy (ie, those with a presumptive diagnosis of GERD, a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD) and whom the investigator judges would need to receive IV PPI therapy for at least 4 days.
- Body weight > 5th percentile for age.
- Y-site or dedicated IV line for administration of pantoprazole sodium.
- Expected survival for at least 30 days.
- Fertile male and female subjects of childbearing potential at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. Female subjects of non-childbearing potential must be premenarchal, have undergone hysterectomy with bilateral oophorectomy, have medically confirmed ovarian failure, or achieved post-menopausal status.
Who cannot join
- Participation in other studies involving investigational drug(s) or treatment with an investigational drug within 30 days or 5 half lives prior to study entry and/or during study participation.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- Pregnant females; breastfeeding females; fertile male subjects, and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after last dose of investigational product.
- Serum CK levels >3x ULN.
- Known history of HIV or clinical manifestations of AIDS.
- Known hypersensitivity to PPIs or to any substituted benzimidazole or to any of the excipients.
Show all 14Show fewer
- History of treatment with any PPI within 2 days (48 hours) before investigational product dosing on Day 1.
- Use of H2RAs, sucralfate, misoprostol, or prokinetic agents, and bismuth preparations within 1 day (24 hours) before investigational product dosing on Day 1.
- Any disorder requiring chronic (every day) use of warfarin, carbamazepine, or phenytoin, methotrexate, atazanavir or nelfinavir, clopidogrel, and potent inhibitors and inducers of CYP2C19.
- Chronic (daily) use of glucocorticoids. Steroid inhalers and topical steroids may be used.
- Active malignancy of any type, or history of a malignancy (Subject with a history of malignancies that have been surgically removed or eradicated by irradiation or chemotherapy and who have no evidence of recurrence for at least 5 years before Screening are acceptable).
- ALT or BUN >2.0 ULN or estimated creatinine >1.5 X ULN for age or any other laboratory abnormality considered by the Investigator to be clinically significant within 14 days before Screening.
- In the Investigator's opinion, a chronic condition (eg, diabetes, epilepsy), which is either not stable or well controlled and may interfere with the conduct of the study.
- History of sensitivity to heparin or heparin induced thrombocytopenia.
Trial locations and contacts
19 sites in 9 countries.
19 sites in 9 countries
United States3 sites
Children's Health Specialty Center Dallas Campus
Dallas, Texas, 75207
Children's Medical Center Dallas
Dallas, Texas, 75235
Primary Children's Hospital
Salt Lake City, Utah, 84113
Italy3 sites
Centro Trials - Dipartimento Pediatrico Universitario Ospedaliero Padiglione Salviati
Roma, 00165
IRCCS Ospedale Pediatrico Bambino Gesù
Roma, 00165
IRCCS-Ospedale Pediatrico Bambino Gesù Farmacia Ospedaliera
Roma, 00165
Ukraine3 sites
Komunalne pidpryiemstvo Dnipropetrovskyi spetsializovanyi klinichnyi medychnyi tsentr materi
Dnipro, 49006
Komunalne nekomertsiine pidpryiemstvo Ivano-Frankivska oblasna dytiacha klinichna likarnia
Ivano-Frankivsk, 76018
Komunalne nekomertsiine pidpryiemstvo "Khersonska dytiacha oblasna klinichna likarnia"
M. Kherson, 73013
Georgia2 sites
JSC Evex Medical Corporation
Tbilisi, 0159
LTD Imedi Clinic
Tbilisi, 0159
Germany2 sites
Katholisches Klinikum Bochum
Bochum, 44791
Zentralapotheke St. Josef-Hospital
Bochum, 44791
Serbia2 sites
University Children's Clinic
Belgrade, 11000
Institute for Child and Youth Health Care of Vojvodina
Novi Sad, 21000
Slovakia2 sites
Narodny ustav detskych chorob
Bratislava, 833 40
Univerzitna nemocnica Martin
Martin, 036 59
Argentina1 site
Hospital Militar Central "Cirujano Mayor Dr. Cosme Argerich"
CABA, Buenos Aires, C1426BOS
Bosnia and Herzegovina1 site
University clinical center of the Republic of Srpska
Banja Luka, 78000
About this study
Official title: AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE PHARMACOKINETICS OF SINGLE AND MULTIPLE INTRAVENOUS DOSES OF PANTOPRAZOLE IN TWO AGE COHORTS OF HOSPITALIZED PEDIATRIC SUBJECTS 1 TO 16 YEARS OF AGE WHO ARE CANDIDATES FOR ACID SUPPRESSION THERAPY
The purpose of this study is to characterize the pharmacokinetics (PK) and safety of intravenous (IV) pantoprazole in patients 1 to 16 years old who are candidates for acid suppression therapy.
Read the detailed description
In hospitalized pediatric subjects, age 1 to 16 years who in the judgment of the investigator are candidates for acid suppression therapy, the following are the objectives of this trial:
Primary Objectives To characterize the PK of single and multiple IV doses of pantoprazole in pediatric subjects aged 1 to less than 2 years old.
To characterize the PK of single and multiple IV doses of pantoprazole in pediatric subjects aged 2 to 16 years old.
Secondary Objectives To determine the safety, tolerability, and PK of single and multiple IV doses of pantoprazole in each of the independent age cohorts.
To assess the CYP2C19 genotype in pediatric subjects receiving IV pantoprazole, to determine the presence of the gene for the major enzyme responsible for metabolism of pantoprazole.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- IV pantoprazole
- Keywords
- candidate for acid suppression therapy, presumptive diagnosis of GERD, clinical diagnosis of suspected GERD, symptomatic GERD, endoscopically proven GERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV pantoprazoleDrug
Patients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight
| Study group | Role | What they receive |
|---|---|---|
| IV pantoprazole | Experimental | Patients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight. Receives: Drug: IV pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance (CL) of Pantoprazole
Data reported below is combined for Days 1, 2 and 7.
Measured: 0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7
Volume of Distribution (Vd) of Pantoprazole
Data reported below is combined for Days 1, 2 and 7.
Measured: 0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7
Secondary outcomes (13)
Maximum Plasma Concentration (Cmax) of Pantoprazole: Single Dose
The results for Cmax were presented separately for single dose and multiple doses.
Measured: 0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1
Cmax of Pantoprazole: Multiple Dose
Data reported below is combined for Days 2 and 7.
Measured: 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7
Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Single Dose
The results for AUC24 were presented separately for single dose and multiple doses.
Measured: 0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 24 hours post dose on Day 1 (pre dose on Day 2)
Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Multiple Dose
Data reported below is combined for Days 2 and 7.
Measured: 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7
Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Single Dose
The results for AUCinf were presented separately for single dose and multiple doses.
Measured: 0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1
Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Multiple Dose
Data reported below is combined for Days 2 and 7.
Measured: 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7
Terminal Half-Life (t1/2) of Pantoprazole
Data reported below is combined for Days 1, 2 and 7.
Measured: 0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7
Number of Participants According to CYP2C19 Genotyping
CYP2C19 genotype was assessed in pediatric participants who received intravenous pantoprazole sodium and determined the presence of the gene for the major enzyme responsible for metabolism of pantoprazole.
Measured: Day 1
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product; the event need not necessarily had a causal relationship with the treatment or usage.
Measured: From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Number of Participants With Laboratory Abnormalities of Potential Clinical Concern
Number of participants with abnormalities in laboratory parameters of potential clinical concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.
Measured: Up to Day 9
Number of Participants With Physical Examination Abnormalities of Potential Clinical Concern
Number of participants with abnormalities in physical examination of potential concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.
Measured: At screening (Day 0)
Number of Participants With Blood Pressure Abnormalities of Potential Clinical Concern
Number of participants with abnormalities in blood pressure of potential clinical concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.
Measured: Up to Day 9
Number of Participants With Pulse Rate Abnormalities of Potential Clinical Concern
Number of participants with abnormalities in pulse rate of potential clinical concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.
Measured: Up to Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study start9 May 2017
- Primary completion18 Jun 2021
- Study completion18 Jun 2021
Why it stopped: Study was terminated early due to the infeasibility of enrolling the required number of participants per protocol in the 1 \<2 years of age cohort.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401035
- Sponsor's protocol ID
- B1791089
- Other IDs
- 2014-002182-29, B1791089, GERD, 2014
- Status last verified
- Mar 2024
- First submitted
- 15 Dec 2014
- Last updated
- 9 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE PHARMACOKINETICS OF SINGLE AND MULTIPLE INTRAVENOUS DOSES OF PANTOPRAZOLE IN TWO AGE COHORTS OF HOSPITALIZED PEDIATRIC SUBJECTS 1 TO 16 YEARS OF AGE WHO ARE CANDIDATES FOR ACID SUPPRESSION THERAPY
- ClinicalTrials.gov ID
- NCT02401035
- Acronym / sponsor ID
- B1791089
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- candidate for acid suppression therapy, presumptive diagnosis of GERD, clinical diagnosis of suspected GERD, symptomatic GERD, endoscopically proven GERD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated early due to the infeasibility of enrolling the required number of participants per protocol in the 1 \<2 years of age cohort.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 9 May 2017 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Posted 9 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to characterize the pharmacokinetics (PK) and safety of intravenous (IV) pantoprazole in patients 1 to 16 years old who are candidates for acid suppression therapy.
Detailed description
In hospitalized pediatric subjects, age 1 to 16 years who in the judgment of the investigator are candidates for acid suppression therapy, the following are the objectives of this trial:
Primary Objectives To characterize the PK of single and multiple IV doses of pantoprazole in pediatric subjects aged 1 to less than 2 years old.
To characterize the PK of single and multiple IV doses of pantoprazole in pediatric subjects aged 2 to 16 years old.
Secondary Objectives To determine the safety, tolerability, and PK of single and multiple IV doses of pantoprazole in each of the independent age cohorts.
To assess the CYP2C19 genotype in pediatric subjects receiving IV pantoprazole, to determine the presence of the gene for the major enzyme responsible for metabolism of pantoprazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IV pantoprazole | Experimental | Drug: IV pantoprazolePatients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight. |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects aged 1 to 16 years who in the judgment of the investigator are candidates for gastric acid suppression therapy (ie, those with a presumptive diagnosis of GERD, a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD) and whom the investigator judges would need to receive IV PPI therapy for at least 4 days.
- Body weight > 5th percentile for age.
- Y-site or dedicated IV line for administration of pantoprazole sodium.
- Expected survival for at least 30 days.
- Fertile male and female subjects of childbearing potential at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. Female subjects of non-childbearing potential must be premenarchal, have undergone hysterectomy with bilateral oophorectomy, have medically confirmed ovarian failure, or achieved post-menopausal status.
Key exclusion criteria (14 listed)
- Participation in other studies involving investigational drug(s) or treatment with an investigational drug within 30 days or 5 half lives prior to study entry and/or during study participation.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- Pregnant females; breastfeeding females; fertile male subjects, and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after last dose of investigational product.
- Serum CK levels >3x ULN.
- Known history of HIV or clinical manifestations of AIDS.
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 |
|---|---|---|
| IV pantoprazolePatients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight | Drug | IV pantoprazole |
Primary outcome
Clearance (CL) of Pantoprazole
Time frame: 0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7
Data reported below is combined for Days 1, 2 and 7.
Volume of Distribution (Vd) of Pantoprazole
Time frame: 0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7
Data reported below is combined for Days 1, 2 and 7.
13 secondary outcomes
Maximum Plasma Concentration (Cmax) of Pantoprazole: Single Dose
Time frame: 0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1
Cmax of Pantoprazole: Multiple Dose
Time frame: 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7
Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Single Dose
Time frame: 0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 24 hours post dose on Day 1 (pre dose on Day 2)
Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Multiple Dose
Time frame: 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7
Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Single Dose
Time frame: 0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1
Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Multiple Dose
Time frame: 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7
Terminal Half-Life (t1/2) of Pantoprazole
Time frame: 0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7
Number of Participants According to CYP2C19 Genotyping
Time frame: Day 1
Number of Participants With Adverse Events (AEs)
Time frame: From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Number of Participants With Laboratory Abnormalities of Potential Clinical Concern
Time frame: Up to Day 9
Number of Participants With Physical Examination Abnormalities of Potential Clinical Concern
Time frame: At screening (Day 0)
Number of Participants With Blood Pressure Abnormalities of Potential Clinical Concern
Time frame: Up to Day 9
Number of Participants With Pulse Rate Abnormalities of Potential Clinical Concern
Time frame: Up to Day 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
19 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IV pantoprazole in people with Gastroesophageal Reflux Disease, run by Pfizer at 19 sites in 9 countries.
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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Italy, Ukraine, Georgia, Germany and 4 more countries. 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 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?
Yes. Results are posted in the registry (first posted 9 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clearance (CL) of Pantoprazole (time frame: 0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7). The study lists 2 primary outcomes in all. 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 9 Apr 2024.