HealthyPhase 1NCT00679705
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
A Phase 1 study testing Ritodrine and Atosiban in people with Healthy, run by University Hospital, Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ritodrine and Atosiban
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteBelgium
- Study dates
- May 2008to Nov 2008
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
- Conditions
- Healthy
- Being tested
- Ritodrine, Atosiban, Placebo
- Keywords
- Hemodynamics and arterial function of healthy females
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RitodrineDrug
Ritodrine (Pre-Par), maximum 400 µg/minute, IV
AtosibanDrug
Atosiban (Tractocile), maximum 300 µg/minute, IV
PlaceboDrug
Glucose 5%, IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ritodrine (Pre-Par) Receives: Drug: Ritodrine |
| 2 | Experimental | Atosiban (Tractocile) Receives: Drug: Atosiban |
| 3 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamical effects of Ritodrine and Atosiban in comparison of those of placebo.
Measured: 240 minutes
Secondary outcomes (5)
Effect of the specific dosing levels of the medications on the level of arterial stiffness
Measured: 240 minutes
Effect of the specific dosing levels of the medications on the effects of the peripheral pulse wave reflections on the central, systolic blood pressure
Measured: 240 minutes
Effect of the specific dosing levels of the medications on the distensibility of the blood vessel wall
Measured: 240 minutes
Effect of the specific dosing levels of the medications on the cardiac output and total peripheral resistance
Measured: 240 minutes
Effect of the specific dosing levels of the medications on peripheral brachial, systolic and diastolic blood pressure
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study startMay 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Luc Van Bortel, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679705
- Sponsor's protocol ID
- 2008/110
- Status last verified
- Apr 2009
- First submitted
- 15 May 2008
- Last updated
- 20 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00679705
- Acronym / sponsor ID
- 2008/110
- Conditions
- Healthy
- Keywords
- Hemodynamics and arterial function of healthy females
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 19 May 2008 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RitodrineRitodrine (Pre-Par) |
| 2 | Experimental | Drug: AtosibanAtosiban (Tractocile) |
| 3 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| RitodrineRitodrine (Pre-Par), maximum 400 µg/minute, IV | Drug | 1 |
| AtosibanAtosiban (Tractocile), maximum 300 µg/minute, IV | Drug | 2 |
| PlaceboGlucose 5%, IV | Drug | 3 |
Primary outcome
Hemodynamical effects of Ritodrine and Atosiban in comparison of those of placebo.
Time frame: 240 minutes
5 secondary outcomes
Effect of the specific dosing levels of the medications on the level of arterial stiffness
Time frame: 240 minutes
Effect of the specific dosing levels of the medications on the effects of the peripheral pulse wave reflections on the central, systolic blood pressure
Time frame: 240 minutes
Effect of the specific dosing levels of the medications on the distensibility of the blood vessel wall
Time frame: 240 minutes
Effect of the specific dosing levels of the medications on the cardiac output and total peripheral resistance
Time frame: 240 minutes
Effect of the specific dosing levels of the medications on peripheral brachial, systolic and diastolic blood pressure
Time frame: 240 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2009.
- Website of the University Hospital GhentLink provided by the sponsor.
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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.
Luc Van Bortel, MD, PhD principal investigator
University Hospital, Ghent
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 Ritodrine and Atosiban in people with Healthy, run by University Hospital, Ghent at 1 site in Belgium.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 20 Apr 2009. 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 Belgium. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hemodynamical effects of Ritodrine and Atosiban in comparison of those of placebo. (time frame: 240 minutes). 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 20 Apr 2009.