Study to Evaluate the Interaction Between Aspirin and Nexium

NCT01199328 | Completed Phase 1

• 1 other identifier: D961FC00011
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the interaction between aspirin and Nexium in healthy volunteers.

Conditions

Healthy Volunteers

Keywords

Nexium; aspirin; peptic ulcers; pharmacodynamic (PD); Esomoeprazole

Outcome Measures

Primary Outcomes (1)

• Evaluate the effect of esomeprazole on low-dose aspirin pharmacodynamics by assessing the relative change in the VerifyNow Aspirin test after 5 days of treatment, relative to baseline (Day 1) in healthy human volunteers

  Ongoing throughout the study from consent through withdrawal

Secondary Outcomes (2)

• Evaluate the effect of esomeprazole on low-dose aspirin pharmacodynamics by assessing the relative change in serum thromboxane B2 inhibition from baseline

  Ongoing throughout the study from consent through withdrawal

• Evaluate safety and tolerability of esomeprazole taken concurrently with low- dose aspirin

  Ongoing throughout the study from consent through withdrawal

Study Arms (2)

1

ACTIVE COMPARATOR

Aspirin 81 mg

Drug: Aspirin

2

ACTIVE COMPARATOR

Esomeprazole 20mg/aspirin 81mg

Drug: Aspirin; Drug: Esomeprazole

Interventions

Aspirin DRUG

81mg Tablet oral, once daily

1; 2

Esomeprazole DRUG

20 mg Tablet oral, once daily

Also known as: Nexium

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision informed consent prior to any study specific procedures.
• Healthy male and female subjects aged 18 to 75 years with suitable veins for cannulation or repeated vein puncture.
• Healthy female subjects must be of non-childbearing potential (post-menopausal, had a hysterectomy and/or bilateral oophorectomy) or be of childbearing potential and have a negative serum hCG pregnancy test during screening and be using of the following methods of birth control:
• Continuously practice abstinence during screening and throughout the duration of the study
• Clinically accepted contraception as described under item 7 of Section 5.1 and on hormonal contraceptives.
• Have a body mass index (BMI) between 19 and 30 kg/m2
• No clinically significant abnormal findings as judged by the Investigator on enrollment physical exam.

You may not qualify if:

• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
• Previous enrolment or randomisation in the present study.
• History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study e.g. history of any bleeding disorder, excessive bruising or ongoing or history of liver disease
• History or presence of clinically significant gastrointestinal e.e. GI ulcer, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
• Any clinically significant illness within 4 weeks of the first administration of investigational product.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Springfield, Missouri, United States

Location

Related Publications (1)

• Andersson T, Morrison D, Nagy P, Pisupati J, Schettler J, Warner TD. Evaluation of the pharmacodynamics of acetylsalicylic acid 81 mg with or without esomeprazole 20 mg in healthy volunteers. Am J Cardiovasc Drugs. 2012 Aug 1;12(4):217-24. doi: 10.1007/BF03261830.

  PMID: 22631032 DERIVED

MeSH Terms

Conditions

Peptic Ulcer

Interventions

Aspirin; Esomeprazole

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dennis N Morrison, MD

  Bio-Kinetic Clinical Applications

  PRINCIPAL INVESTIGATOR

• Tore Lind

  AstraZeneca

  STUDY DIRECTOR

• Lynne Durborow

  AstraZeneca

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 10, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 19, 2010

Record last verified: 2010-11

Locations

US (1)