UlcersPhase 1NCT00688428
Study Comparing a Fixed-Dose Capsule of Esomeprazole 40mg and LDA 325mg With Free Combination
A Phase 1 study testing Esomeprazole 40mg/ASA 325mg, Esomeprazole and ASA in people with Ulcers and Upper GI Symptoms, run by AstraZeneca.
Trial summary
The purpose of this study is to test if fixed dose esomeprazole and ASA capsule is pharmaceutically equal to a free combination of esomeprazole capsule and ASA tablet Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcers, Upper GI Symptoms
- What is being tested?
- Esomeprazole 40mg/ASA 325mg, Esomeprazole and ASA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Apr 2008
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index of 19-29kg/m2, inclusive
- Weight of 50-95kg, inclusive
- Clinically normal physical findings and laboratory values including hepatitis B, hepatitis C, and HIV, as judged by the Investigator
Who cannot join
- Significant clinical illness within the 2 weeks preceding the first dose of investigational products, as judged by the Investigator
- History of mental, cardiac, renal, hepatitis, neurological, or significant gastrointestinal disease, as judged by the Investigator
- Condition which could modify the absorption of the investigational products, as judged by the Investigator
About this study
Official title: A Phase I, Open-Label, Randomized, Single-Center, 2-Stage Group Sequential Design, 2-Way Crossover Bioequivalence Study Comparing a Fixed-Dose Combination Capsule of Esomeprazole 40mg and Low-Dose Acetylsalicylic Acid (ASA) 325mg With a Free Combination of Esomeprazole Capsule 40mg and Low-Dose ASA
The purpose of this study is to test if fixed dose esomeprazole and ASA capsule is pharmaceutically equal to a free combination of esomeprazole capsule and ASA tablet
- Conditions
- Ulcers, Upper GI Symptoms
- Being tested
- Esomeprazole 40mg/ASA 325mg, Esomeprazole, ASA
- Keywords
- esomeprazole, upper gi symptoms, low dose Aspirin treatment
- Medical subject headings
- Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole 40mg/ASA 325mgDrug
Also called Nexium/Bayer Aspirin
combination capsule, administered as a single oral dose
EsomeprazoleDrug
Also called Nexium
40mg capsule, administered as a single dose
ASADrug
Also called Bayer aspirin
325mg tablet, administered as a single oral dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | combination capsule of Esomeprazole 40mg + ASA 325mg Receives: Drug: Esomeprazole 40mg/ASA 325mg |
| 2 | Experimental | Esomeprazole 40 mg capsule and ASA 325 mg tablet Receives: Drug: Esomeprazole; Drug: ASA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Samples for measurement of esomeprazole, ASA, and SA concentrations
Measured: Day 1 of each period
Secondary outcomes (2)
Fasting blood samples for determination of clinical chemistry and hematology parameters
Measured: screening and follow up visit
urine samples for urinalysis parameters
Measured: screening, Period 1, and follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UlcersStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jörgen Naesdal, M.D., Study director, AstraZenecaChristopher Billings ., D.O, Principal investigator, Biokinetics Clinical Applications
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688428
- Sponsor's protocol ID
- D961FC00002
- Status last verified
- Mar 2009
- First submitted
- 30 May 2008
- Last updated
- 12 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Randomized, Single-Center, 2-Stage Group Sequential Design, 2-Way Crossover Bioequivalence Study Comparing a Fixed-Dose Combination Capsule of Esomeprazole 40mg and Low-Dose Acetylsalicylic Acid (ASA) 325mg With a Free Combination of Esomeprazole Capsule 40mg and Low-Dose ASA
- ClinicalTrials.gov ID
- NCT00688428
- Acronym / sponsor ID
- D961FC00002
- Conditions
- Ulcers, Upper GI Symptoms
- Keywords
- esomeprazole, upper gi symptoms, low dose Aspirin treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 3 Jun 2008 (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 purpose of this study is to test if fixed dose esomeprazole and ASA capsule is pharmaceutically equal to a free combination of esomeprazole capsule and ASA tablet
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Esomeprazole 40mg/ASA 325mgcombination capsule of Esomeprazole 40mg + ASA 325mg |
| 2 | Experimental | Drug: Esomeprazole, Drug: ASAEsomeprazole 40 mg capsule and ASA 325 mg tablet |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index of 19-29kg/m2, inclusive
- Weight of 50-95kg, inclusive
- Clinically normal physical findings and laboratory values including hepatitis B, hepatitis C, and HIV, as judged by the Investigator
Key exclusion criteria (3 listed)
- Significant clinical illness within the 2 weeks preceding the first dose of investigational products, as judged by the Investigator
- History of mental, cardiac, renal, hepatitis, neurological, or significant gastrointestinal disease, as judged by the Investigator
- Condition which could modify the absorption of the investigational products, as judged by the Investigator
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 40mg/ASA 325mgAlso: Nexium/Bayer Aspirincombination capsule, administered as a single oral dose | Drug | 1 |
| EsomeprazoleAlso: Nexium40mg capsule, administered as a single dose | Drug | 2 |
| ASAAlso: Bayer aspirin325mg tablet, administered as a single oral dose | Drug | 2 |
Primary outcome
Samples for measurement of esomeprazole, ASA, and SA concentrations
Time frame: Day 1 of each period
2 secondary outcomes
Fasting blood samples for determination of clinical chemistry and hematology parameters
Time frame: screening and follow up visit
urine samples for urinalysis parameters
Time frame: screening, Period 1, and follow-up visit
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 12 Mar 2009.
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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.
Jörgen Naesdal, M.D. study director
AstraZeneca
Christopher Billings ., D.O principal investigator
Biokinetics Clinical Applications
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Esomeprazole 40mg/ASA 325mg, Esomeprazole and ASA in people with Ulcers and Upper GI Symptoms, run by AstraZeneca.
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 3 inclusion and 3 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 12 Mar 2009. 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 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?
Samples for measurement of esomeprazole, ASA, and SA concentrations (time frame: Day 1 of each period). 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 12 Mar 2009.