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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01369186
Other study ID # 2010-023761-22
Secondary ID
Status Completed
Phase Phase 4
First received June 7, 2011
Last updated March 23, 2017
Start date May 2011
Est. completion date January 2015

Study information

Verified date March 2017
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study Objective: To investigate potential drug-drug interactions (pharmacokinetics and pharmacodynamics) of morphine and antiplatelet drugs (aspirin, clopidogrel, prasugrel, ticagrelor)


Description:

Rationale: Opiates reduce the intestinal resorption of orally administered drugs such as paracetamol. Because morphine is often injected to relieve pain in patients with myocardial infarction, it is of particular interest if morphine may decrease the rate of absorption of antiplatelet drugs. Results of this study will provide essential information for the use of morphine and antiplatelet drugs in clinical practice, in particular in myocardial infarction.


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Healthy volunteers = 18 years of age

- No intake of NSARs and P2Y12-inhibitors within 14 days before study entry

- Written informed consent

Exclusion Criteria:

- Known coagulation disorders

- Relevant impairment of hepatic function (elevated transaminases, = 2 fold)

- Relevant impairment of renal function

- Infectious diseases (HIV, hepatitis B and C)

- Gestation and lactation

- Clinically relevant abnormal laboratory values

- Use of medication during 2 weeks before the start of the study, which may affect the validity of the study

- General contraindications for aspirin (resp. clopidogrel, prasugrel, ticagrelor) and morphine

Study Design


Intervention

Drug:
Morphine
i.v. bolus injection
Placebo
i.v. bolus injection

Locations

Country Name City State
Austria Medical University of Vienna, Department of Clinical Pharmacology Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (2)

Hobl EL, Schmid RW, Stimpfl T, Ebner J, Jilma B. Absorption kinetics of low-dose chewable aspirin--implications for acute coronary syndromes. Eur J Clin Invest. 2015 Jan;45(1):13-7. doi: 10.1111/eci.12373. — View Citation

Hobl EL, Stimpfl T, Ebner J, Schoergenhofer C, Derhaschnig U, Sunder-Plassmann R, Jilma-Stohlawetz P, Mannhalter C, Posch M, Jilma B. Morphine decreases clopidogrel concentrations and effects: a randomized, double-blind, placebo-controlled trial. J Am Coll Cardiol. 2014 Feb 25;63(7):630-5. doi: 10.1016/j.jacc.2013.10.068. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Platelet function 14 days
Secondary Tmax 14 days
Secondary Cmax 14 days
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