HealthyPhase 1NCT02187562
Effect of Steady State Meloxicam on Low Dose Aspirin Induced Inhibition of Platelet Aggregation and Thromboxane Synthesis in Healthy Males and Females
A Phase 1 study testing Meloxicam and Aspirin in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of this study was to investigate the influence of meloxicam on low dose aspirin induced inhibition of platelet aggregation and thromboxane B2, when meloxicam is given before aspirin. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Meloxicam and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jul 2002to Aug 2002
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age >=18 and <= 60 years
- The Body Mass Index (BMI) ≥ 18.5 kg/m2 (square meters) and ≤ 29.9 kg/m2.
- Laboratory values within a clinical normal range
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastro-intestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
Show all 31Show fewer
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (> 24 hours) (< 1 month prior to administration or during the trial)
- Use of any drugs, which might influence the results of the trial, in particular aspirin containing drugs(< 14 days prior to administration or during the trial)
- Participation in another trial with an investigational drug (< 1 months prior to administration (at least 10 times the relevant elimination half-life) or during trial)
- Having had prescription medication 2 weeks prior to study drug administration or over the counter medication 1 week prior to study drug administration (at least 10 times the relevant elimination half-life)
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (> 60 grams (g)/day)
- Drug abuse
- Blood donation or loss > 400 mL (< 1 month prior to administration or during the trial)
- Excessive physical activities (< 5 days prior to administration or during the trial)
- Any ECG value outside of the reference range of clinical relevance including, but not limited to QTcB > 480 ms or QRS interval > 110 ms
- History of any familial bleeding disorder
- History of haemorrhagic diatheses
- History of gastrointestinal ulcer, perforation or bleeding
- History of bronchial asthma
- Inability to comply with dietary regimen of study centre
- Inability to comply with investigator's instructions
- For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception (e.g. sterilisation, intrauterine device (IUP), oral contraceptives)
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
- Ovarian hormone substitution and oral contraception have to be continued during the study
About this study
Official title: Effect of Steady State Meloxicam 15 mg/Day on Low Dose Aspirin (100 mg/Day) Induced Inhibition of Platelet Aggregation and Thromboxane Synthesis in Healthy Males and Females. An Open, Randomised, Two-way Crossover Study.
The objective of this study was to investigate the influence of meloxicam on low dose aspirin induced inhibition of platelet aggregation and thromboxane B2, when meloxicam is given before aspirin.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeloxicamDrug
AspirinDrug
| Study group | Role | What they receive |
|---|---|---|
| Meloxicam/Aspirin | Experimental | Meloxicam days 1-10 / Aspirin days 5-10 Receives: Drug: Meloxicam; Drug: Aspirin |
| Aspirin | Active comparator | Aspirin 2 days Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arachidonic acid induced platelet aggregation
Measured: up to day 11 (treatment 1), up to day 3 (treatment 2)
Secondary outcomes (8)
Collagen-induced Platelet Aggregation
Measured: up to day 11 (treatment 1), up to day 3 (treatment 2)
Adenosine diphosphate (ADP) Induced Platelet Aggregation
Measured: up to day 11 (treatment 1), up to day 3 (treatment 2)
Serum Thromboxane B2 production
Measured: up to day 11 (treatment 1), up to day 3 (treatment 2)
Number of patients with adverse events
Measured: up to 6 weeks
Number of patients with abnormal changes in laboratory parameters
Measured: up to day 11 (treatment 1), up to day 3 (treatment 2)
Number of patients with abnormal changes in 12-lead electrocardiogram (ECG)
Measured: Screening, 24 hours after the last Aspirin intake
Number of patients with clinically significant changes in vital signs
Measured: Screening, 24 hours after the last Aspirin intake
Assessment of tolerability on a 4-point scale
Measured: 24 hours after the last Aspirin intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJul 2002
- Primary completionAug 2002
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 Boehringer IngelheimThe 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
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187562
- Sponsor's protocol ID
- 107.255
- Status last verified
- Jul 2014
- First submitted
- 10 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Steady State Meloxicam 15 mg/Day on Low Dose Aspirin (100 mg/Day) Induced Inhibition of Platelet Aggregation and Thromboxane Synthesis in Healthy Males and Females. An Open, Randomised, Two-way Crossover Study.
- ClinicalTrials.gov ID
- NCT02187562
- Acronym / sponsor ID
- 107.255
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Aug 2002 (actual)
- First posted
- 11 Jul 2014 (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.
The objective of this study was to investigate the influence of meloxicam on low dose aspirin induced inhibition of platelet aggregation and thromboxane B2, when meloxicam is given before aspirin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meloxicam/Aspirin | Experimental | Drug: Meloxicam, Drug: AspirinMeloxicam days 1-10 / Aspirin days 5-10 |
| Aspirin | Active comparator | Drug: AspirinAspirin 2 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age >=18 and <= 60 years
- The Body Mass Index (BMI) ≥ 18.5 kg/m2 (square meters) and ≤ 29.9 kg/m2.
- Laboratory values within a clinical normal range
Key exclusion criteria (31 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastro-intestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
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 |
|---|---|---|
| Meloxicam | Drug | Meloxicam/Aspirin |
| Aspirin | Drug | Aspirin, Meloxicam/Aspirin |
Primary outcome
Arachidonic acid induced platelet aggregation
Time frame: up to day 11 (treatment 1), up to day 3 (treatment 2)
8 secondary outcomes
Collagen-induced Platelet Aggregation
Time frame: up to day 11 (treatment 1), up to day 3 (treatment 2)
Adenosine diphosphate (ADP) Induced Platelet Aggregation
Time frame: up to day 11 (treatment 1), up to day 3 (treatment 2)
Serum Thromboxane B2 production
Time frame: up to day 11 (treatment 1), up to day 3 (treatment 2)
Number of patients with adverse events
Time frame: up to 6 weeks
Number of patients with abnormal changes in laboratory parameters
Time frame: up to day 11 (treatment 1), up to day 3 (treatment 2)
Number of patients with abnormal changes in 12-lead electrocardiogram (ECG)
Time frame: Screening, 24 hours after the last Aspirin intake
Number of patients with clinically significant changes in vital signs
Time frame: Screening, 24 hours after the last Aspirin intake
Assessment of tolerability on a 4-point scale
Time frame: 24 hours after the last Aspirin intake
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 14 Jul 2014.
- Related InfoLink 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Meloxicam and Aspirin in people with Healthy, run by Boehringer Ingelheim.
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 5 inclusion and 31 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 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Arachidonic acid induced platelet aggregation (time frame: up to day 11 (treatment 1), up to day 3 (treatment 2)). 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 14 Jul 2014.