Influence of Tocolytical Medications on Hemodynamics (Central and Peripheral) and Vascular Function in a Pilot Study to Determine the Design of the Final Study and the Final Study Itself

Healthy Clinical Trial

Official title:

Pilot Study: A Dose-Response Finding Study of Ritodrine (Pre-Par®) to Find the Highest Well Tolerated Dose in Young, Healthy, Female Volunteers. To Find the Size-Order of the Hemodynamical Effects of Ritodrine (PrePar®) and Atosiban (Tractocile®) to Determine the Relevance of a PK/PD-Modelling in the Final Study. Final Study: Investigating the Influence of Tocolytical Medications: Ritodrine (PrePar®) and Atosiban (Tractocile®) at the Clinical Dose on the Hemodynamics and Arterial Function in Healthy Female Volunteers, Compared to Placebo During Continuous Intravenous Infusion.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00679705
• Other study ID #: 2008/110
• Status: Completed
• Phase: Phase 1
• First received: May 15, 2008
• Last updated: April 17, 2009
• Start date: May 2008
• Est. completion date: November 2008

Study information

• Verified date: April 2009
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

This trial will consist of two parts:

A pilot study in a three-way cross over trial to determine the highest well tolerated dose of Ritodrine (Pre-Par®), the impact of Atosiban (Tractocile®) on the hemodynamics and hence the design of the final study.

The final study is planned as a three-way crossover trial to investigate and compare the cardiovascular effects of Ritodrine, Atosiban and placebo to relate those effects to the pharmacokinetics of Ritodrine and Atosiban (PK/PD modelling).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age between 20 and 40 years old;

• In good health, especially no cardiovascular diseases, obstructive lung diseases, chronic kidney diseases or diabetes mellitus.

• Using a proper anticonception method (orally, subcutaneously);

• A negative pregnancy test.

Exclusion Criteria:

• Intolerance of Ritodrine;

• On chronic medication, except oral and subcutaneous contraception

• History or present presentation of cardiac arrythmias;

• Risk of being pregnant or less than 6 months postpartum;

• Giving breastfeeding;

• Previous uteral surgery;

• Using an intra-uteral device (IUD);

• A severe addiction: nicotine (> 10 cigarettes/day), alcohol (> 3 units/day), caffeine (> 5 units/day) or any extralegally drugs.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Ritodrine
Ritodrine (Pre-Par), maximum 400 µg/minute, IV
• Atosiban
Atosiban (Tractocile), maximum 300 µg/minute, IV
• Placebo
Glucose 5%, IV

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamical effects of Ritodrine and Atosiban in comparison of those of placebo.		240 minutes	Yes
Secondary	Effect of the specific dosing levels of the medications on the level of arterial stiffness		240 minutes	Yes
Secondary	Effect of the specific dosing levels of the medications on the effects of the peripheral pulse wave reflections on the central, systolic blood pressure		240 minutes	Yes
Secondary	Effect of the specific dosing levels of the medications on the distensibility of the blood vessel wall		240 minutes	Yes
Secondary	Effect of the specific dosing levels of the medications on the cardiac output and total peripheral resistance		240 minutes	Yes
Secondary	Effect of the specific dosing levels of the medications on peripheral brachial, systolic and diastolic blood pressure		240 minutes	Yes

External Links

•   Website of the University Hospital Ghent