HealthyPhase 1NCT01153659
A Study to Evaluate the Effect on 24-hour, Intragastric pH of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40 mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets
A Phase 1 study testing E3810, Aciphex (rabeprazole) and Nexium (esomeprazole) in people with Healthy, run by Eisai Inc. at 1 site in United States.
Trial summary
This will be a randomized, open-label, single-center, 3-way crossover study in healthy subjects who are confirmed to be Helicobacter pylori (H. pylori)-negative. The study will consist of 3 study periods separated by a washout period of at least 7 days. Subjects will receive study drugs once daily for 5 days. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- E3810, Aciphex (rabeprazole) and Nexium (esomeprazole)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Oct 2010
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects, including women of child-bearing potential, aged 18 to 55 years, inclusive
- Subjects who are able to tolerate the insertion and placement of a pH probe on 2 occasions per study period (Day -1 and Day 5)
Who cannot join
- Subjects who are H. pylori-positive
- Subjects who have a history of any gastrointestinal disorder or surgery likely to influence drug absorption (e.g., history of gastric resection)
- Known hypersensitivity to rabeprazole, esomeprazole, or related compounds or any ingredient in the formulations
- Other standard clinical pharmacology exclusion criteria for healthy volunteers
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104
About this study
Official title: A Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Effect on 24-hour, Intragastric pH Following Daily Oral Dose Administration of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40-mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets to H. Pylori-Negative Healthy Subjects in a 5-day Treatment Regimen
This will be a randomized, open-label, single-center, 3-way crossover study in healthy subjects who are confirmed to be Helicobacter pylori (H. pylori)-negative. The study will consist of 3 study periods separated by a washout period of at least 7 days. Subjects will receive study drugs once daily for 5 days. Barring any safety concerns, subjects will be discharged from the study on Day 6 of Period 3 after completion of discharge procedures.
- Conditions
- Healthy
- Being tested
- E3810, Aciphex (rabeprazole), Nexium (esomeprazole)
- Keywords
- rabeprazole, esomeprazole, h. pylori-negative, nocturnal acid breakthrough, intragastric pH, PK/PD, effect on gastric pH in healthy, H. pylori-Negative subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E3810Drug
RAB ER 50 mg capsule once per day on Days 1-5
Aciphex (rabeprazole)Drug
Aciphex (rabeprazole) 20 mg tablet once per day on Days 1-5
Nexium (esomeprazole)Drug
Nexium (esomeprazole) 40 mg capsule once per day on Days 1-5
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: E3810 |
| 2 | Active comparator | Not described Receives: Drug: Aciphex (rabeprazole) |
| 3 | Active comparator | Not described Receives: Drug: Nexium (esomeprazole) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time that intragastric pH remains >4
Measured: 24-hr period post-dose on Day 5
Secondary outcomes (3)
Percentage of day- and night-time periods with intragastric pH >4
Measured: Days 1 and 5
Number and duration of nocturnal acid breakthrough (NAB) episodes
Measured: Days 1 and 5
Proportion of subjects with nocturnal acid breakthrough (NAB) episodes
Measured: Days 1 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionAug 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Miner, Principal investigator, Oklahoma Foundation for Digestive Research, 1000 N. Lincoln, Suite 210, Oklahoma City, OK 73104 USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153659
- Sponsor's protocol ID
- E3810-A001-038
- Status last verified
- Oct 2013
- First submitted
- 28 Jun 2010
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Effect on 24-hour, Intragastric pH Following Daily Oral Dose Administration of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40-mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets to H. Pylori-Negative Healthy Subjects in a 5-day Treatment Regimen
- ClinicalTrials.gov ID
- NCT01153659
- Acronym / sponsor ID
- E3810-A001-038
- Conditions
- Healthy
- Keywords
- rabeprazole, esomeprazole, h. pylori-negative, nocturnal acid breakthrough, intragastric pH, PK/PD, effect on gastric pH in healthy, H. pylori-Negative subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 30 Jun 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.
This will be a randomized, open-label, single-center, 3-way crossover study in healthy subjects who are confirmed to be Helicobacter pylori (H. pylori)-negative. The study will consist of 3 study periods separated by a washout period of at least 7 days. Subjects will receive study drugs once daily for 5 days. Barring any safety concerns, subjects will be discharged from the study on Day 6 of Period 3 after completion of discharge procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: E3810 |
| 2 | Active comparator | Drug: Aciphex (rabeprazole) |
| 3 | Active comparator | Drug: Nexium (esomeprazole) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and female subjects, including women of child-bearing potential, aged 18 to 55 years, inclusive
- Subjects who are able to tolerate the insertion and placement of a pH probe on 2 occasions per study period (Day -1 and Day 5)
Key exclusion criteria (4 listed)
- Subjects who are H. pylori-positive
- Subjects who have a history of any gastrointestinal disorder or surgery likely to influence drug absorption (e.g., history of gastric resection)
- Known hypersensitivity to rabeprazole, esomeprazole, or related compounds or any ingredient in the formulations
- Other standard clinical pharmacology exclusion criteria for healthy volunteers
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 |
|---|---|---|
| E3810RAB ER 50 mg capsule once per day on Days 1-5 | Drug | 1 |
| Aciphex (rabeprazole)Aciphex (rabeprazole) 20 mg tablet once per day on Days 1-5 | Drug | 2 |
| Nexium (esomeprazole)Nexium (esomeprazole) 40 mg capsule once per day on Days 1-5 | Drug | 3 |
Primary outcome
Percentage of time that intragastric pH remains >4
Time frame: 24-hr period post-dose on Day 5
3 secondary outcomes
Percentage of day- and night-time periods with intragastric pH >4
Time frame: Days 1 and 5
Number and duration of nocturnal acid breakthrough (NAB) episodes
Time frame: Days 1 and 5
Proportion of subjects with nocturnal acid breakthrough (NAB) episodes
Time frame: Days 1 and 5
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 1 Nov 2013.
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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.
Philip Miner principal investigator
Oklahoma Foundation for Digestive Research, 1000 N. Lincoln, Suite 210, Oklahoma City, OK 73104 USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E3810, Aciphex (rabeprazole) and Nexium (esomeprazole) in people with Healthy, run by Eisai Inc. at 1 site in United States.
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 2 inclusion and 4 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 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 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 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?
Percentage of time that intragastric pH remains >4 (time frame: 24-hr period post-dose on Day 5). 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 1 Nov 2013.