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ASA

Phase 1

Peptic Ulcer Disease | Small molecule | Gastrointestinal |AstraZeneca PLC|Last Updated: Dec 7, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment138

FDA Designations

No designations recorded

Clinical trial landscape

ASA · 2 trials · 3 indications

Phase 1 2
NCT00998075Study Comparing Esomeprazole and Acetylsalicylic Acid (ASA) Combined Together as One Capsule Versus These Medications Taken SeparatelyPeptic Ulcer Disease
COMPLETED138 Analytics
NCT00688428Study Comparing a Fixed-Dose Capsule of Esomeprazole 40mg and LDA 325mg With Free CombinationUlcers
COMPLETED84 Analytics
PHASE1COMPLETED
Study Comparing Esomeprazole and Acetylsalicylic Acid (ASA) Combined Together as One Capsule Versus These Medications Taken Separately
Peptic Ulcer Disease
NCT00998075138
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PHASE1COMPLETED
Study Comparing a Fixed-Dose Capsule of Esomeprazole 40mg and LDA 325mg With Free Combination
Ulcers
NCT0068842884
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Study Endpoints

Primary Endpoints

Plasma concentration-time curve from time 0 to the last quantifiable concentration for esomeprazole administered as fixed dose combination (FDC) to esomeprazole administered as free combinations
PK samples to be taken for bioanalysis over a 24-hour period following dosing on Day 1 of Period I and Day 1 of Period II and III.
Samples for measurement of esomeprazole, ASA, and SA concentrations
Day 1 of each period

Secondary Endpoints

Pharmacokinetics (PK): Total area under the plasma concentration-time curve (AUC0-inf), AUC0-t, Cmax, time to Cmax (Tmax), and half-life (t½) of esomeprazole
PK samples to be taken for bioanalysis over a 24-hour period following dosing for each treatment arm
Fasting blood samples for determination of clinical chemistry and hematology parameters
screening and follow up visit
urine samples for urinalysis parameters
screening, Period 1, and follow-up visit
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATOREsomeprazole 40 mg/ASA 325 mg Fixed Dose Combination Capsule
2ACTIVE_COMPARATOREsomeprazole Clinical Trial Capsule 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg
3ACTIVE_COMPARATOREsomeprazole MUPS Tablet 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg

Interventions

NameTypeDescription
Esomeprazole/ASA Fixed CombinationDRUGCapsule, oral, single dose
Esomeprazole - NexiumDRUGClinical Trial Capsule or MUPS Tablet, oral, single dose
ASADRUGTablet, oral, single dose
Esomeprazole 40mg/ASA 325mgDRUGcombination capsule, administered as a single oral dose
EsomeprazoleDRUG40mg capsule, administered as a single dose
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Eligibility Criteria

Age Range20 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Non-smoking male or female within the age range of 20 to 50 years * Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 29.9 kg/m2 Exclusion Criteria: * Documented upper gastrointestinal surgery * Use of any proton pump inhibi...

Countries:Canada
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Frequently asked questions about ASA

What is ASA used for?

ASA is an investigational small molecule being studied for use in peptic ulcer disease, ulcers, and upper GI symptoms, as well as in healthy volunteers. It is currently in Phase 1 clinical development by AstraZeneca PLC.

Who makes ASA?

AstraZeneca PLC (ticker: AZN) is developing ASA. The drug is an investigational small molecule in Phase 1 clinical trials for gastrointestinal conditions.

What phase is ASA in?

ASA is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All completed trials are Phase 1 studies.

What clinical trials is ASA in?

ASA has been studied in three completed Phase 1 trials: NCT00688428, NCT00998075, and NCT01448031. These trials evaluated ASA in healthy volunteers and patients with ulcers or peptic ulcer disease.

Is ASA the same as acetylsalicylic acid?

ASA is an abbreviation for acetylsalicylic acid, which is aspirin. In clinical trials, ASA is being studied in combination with esomeprazole for gastrointestinal conditions.