Peptic Ulcer DiseasePhase 1NCT01015729
Study Comparing Esomeprazole and ASA Combined Together as One Capsule Versus These Medications Taken Separately
A Phase 1 study testing Esomeprazole/ASA Fixed Combination, Esomeprazole and ASA in people with Peptic Ulcer Disease, run by AstraZeneca at 1 site in Canada.
Trial summary
The purpose of this study is to investigate whether a fixed dose combination (FDC) capsule of esomeprazole 20 mg and acetylsalicylic acid (ASA) 81 mg has equivalent therapeutic efficacy compared to each of 2 free combinations of ASA tablet 81 mg plus esomeprazole 20 mg in patients at risk of gastrointestinal events… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peptic Ulcer Disease
- What is being tested?
- Esomeprazole/ASA Fixed Combination, Esomeprazole and ASA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smoking male and female subjects, aged 18 years or older with a documented history of uncomplicated peptic ulcer(s), or aged 65 years or older
- Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 35.0 kg/m2
Who cannot join
- Known history of hypersensitivity to esomeprazole (e.g. Nexium®) or related drugs such as omeprazole (e.g. Losec®, Prilosec®), lansoprazole (e.g. Prevacid®, Hp-PAC®), pantoprazole (e.g. Pantoloc®, PANTO® IV), or rabeprazole (e.g. Pariet™), a known hypersensitivity to ASA (e.g. Aspirin®) and/or related drugs such as ibuprofen (e.g. Motrin®, Advil®), indomethacin (e.g. Indocin®), diclofenac (e.g. Voltaren®), naproxen (e.g. Aleve®, Naprosyn®), or ketoprofen (e.g. Rhovail®).
- Significant history of pulmonary, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, or gastrointestinal disease (with the exception of uncomplicated peptic ulcer), unless deemed NCS by the Principal Investigator or Sub-investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, Single-Center, 3-Way Crossover Study Comparing The Therapeutic Efficacy of a Fixed Dose Combination Capsule of Esomeprazole 20 mg And Acetylsalicylic Acid (ASA) 81 mg With Free Combinations of ASA Tablet 81 mg And Esomeprazole 20 mg as a Capsule or Tablet in Patients At Risk of Gastrointestinal Events Using Low Dose ASA for Cardiovascular Protection
The purpose of this study is to investigate whether a fixed dose combination (FDC) capsule of esomeprazole 20 mg and acetylsalicylic acid (ASA) 81 mg has equivalent therapeutic efficacy compared to each of 2 free combinations of ASA tablet 81 mg plus esomeprazole 20 mg in patients at risk of gastrointestinal events using low dose ASA for cardiovascular protection.
- Conditions
- Peptic Ulcer Disease
- Being tested
- Esomeprazole/ASA Fixed Combination, Esomeprazole, ASA
- Keywords
- Bioequivalence, ASA, Esomeprazole, peptic ulcer disease, pH measurements
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole/ASA Fixed CombinationDrug
Capsule, oral, single dose
EsomeprazoleDrug
Also called Nexium
oral, single dose
ASADrug
Also called Aspirin
Tablet, oral, single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Esomeprazole 20 mg/ASA 81 mg Fixed Dose Combination Capsule Receives: Drug: Esomeprazole/ASA Fixed Combination |
| 2 | Active comparator | Esomeprazole Clinical Trial Capsule 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg Receives: Drug: Esomeprazole; Drug: ASA |
| 3 | Active comparator | Esomeprazole MUPS Tablet 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg Receives: Drug: Esomeprazole; Drug: ASA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time that intragastric pH is maintained > 4.0 during the 24-hour recording period
Measured: pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing
Secondary outcomes (3)
Percentage of time that intragastric pH is maintained > 3.0 during the 24-hour recording period
Measured: pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing
Median 24-hour intragastric pH
Measured: pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing
Gastrointestinal symptom (Global Overall Symptoms questionnaire)
Measured: GOS questionnaire will be adminsited on day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startNov 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer DiseaseStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- TJorgen Nasdal, MD, PhD, Study director, AstraZeneca R&DPierre Geoffroy, M.D. C.M., M.Sc., F.C.F.P., Principal investigator, Biovail Contract Research (BCR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015729
- Sponsor's protocol ID
- D961FC00008
- Status last verified
- Jan 2012
- First submitted
- 17 Nov 2009
- Last updated
- 16 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Single-Center, 3-Way Crossover Study Comparing The Therapeutic Efficacy of a Fixed Dose Combination Capsule of Esomeprazole 20 mg And Acetylsalicylic Acid (ASA) 81 mg With Free Combinations of ASA Tablet 81 mg And Esomeprazole 20 mg as a Capsule or Tablet in Patients At Risk of Gastrointestinal Events Using Low Dose ASA for Cardiovascular Protection
- ClinicalTrials.gov ID
- NCT01015729
- Acronym / sponsor ID
- D961FC00008
- Conditions
- Peptic Ulcer Disease
- Keywords
- Bioequivalence, ASA, Esomeprazole, peptic ulcer disease, pH measurements
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Study completion
- Mar 2010 (actual)
- First posted
- 18 Nov 2009 (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 investigate whether a fixed dose combination (FDC) capsule of esomeprazole 20 mg and acetylsalicylic acid (ASA) 81 mg has equivalent therapeutic efficacy compared to each of 2 free combinations of ASA tablet 81 mg plus esomeprazole 20 mg in patients at risk of gastrointestinal events using low dose ASA for cardiovascular protection.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Esomeprazole/ASA Fixed CombinationEsomeprazole 20 mg/ASA 81 mg Fixed Dose Combination Capsule |
| 2 | Active comparator | Drug: Esomeprazole, Drug: ASAEsomeprazole Clinical Trial Capsule 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg |
| 3 | Active comparator | Drug: Esomeprazole, Drug: ASAEsomeprazole MUPS Tablet 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-smoking male and female subjects, aged 18 years or older with a documented history of uncomplicated peptic ulcer(s), or aged 65 years or older
- Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 35.0 kg/m2
Key exclusion criteria (2 listed)
- Known history of hypersensitivity to esomeprazole (e.g. Nexium®) or related drugs such as omeprazole (e.g. Losec®, Prilosec®), lansoprazole (e.g. Prevacid®, Hp-PAC®), pantoprazole (e.g. Pantoloc®, PANTO® IV), or rabeprazole (e.g. Pariet™), a known hypersensitivity to ASA (e.g. Aspirin®) and/or related drugs such as ibuprofen (e.g. Motrin®, Advil®), indomethacin (e.g. Indocin®), diclofenac (e.g. Voltaren®), naproxen (e.g. Aleve®, Naprosyn®), or ketoprofen (e.g. Rhovail®).
- Significant history of pulmonary, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, or gastrointestinal disease (with the exception of uncomplicated peptic ulcer), unless deemed NCS by the Principal Investigator or Sub-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/ASA Fixed CombinationCapsule, oral, single dose | Drug | 1 |
| EsomeprazoleAlso: Nexiumoral, single dose | Drug | 2, 3 |
| ASAAlso: AspirinTablet, oral, single dose | Drug | 2, 3 |
Primary outcome
Percentage of time that intragastric pH is maintained > 4.0 during the 24-hour recording period
Time frame: pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing
3 secondary outcomes
Percentage of time that intragastric pH is maintained > 3.0 during the 24-hour recording period
Time frame: pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing
Median 24-hour intragastric pH
Time frame: pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing
Gastrointestinal symptom (Global Overall Symptoms questionnaire)
Time frame: GOS questionnaire will be adminsited on day 5
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2012.
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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.
TJorgen Nasdal, MD, PhD study director
AstraZeneca R&D
Pierre Geoffroy, M.D. C.M., M.Sc., F.C.F.P. principal investigator
Biovail Contract Research (BCR)
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 Esomeprazole/ASA Fixed Combination, Esomeprazole and ASA in people with Peptic Ulcer Disease, run by AstraZeneca at 1 site in Canada.
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 2 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 16 Jan 2012. 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 Canada. 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 was stopped early. 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?
Percentage of time that intragastric pH is maintained > 4.0 during the 24-hour recording period (time frame: pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing). 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 16 Jan 2012.