- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02187562
Effect of Steady State Meloxicam on Low Dose Aspirin Induced Inhibition of Platelet Aggregation and Thromboxane Synthesis in Healthy Males and Females
11. juli 2014 opdateret af: Boehringer Ingelheim
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
16
Fase
- Fase 1
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Meloxicam/Aspirin
Meloxicam days 1-10 / Aspirin days 5-10
|
|
|
Aktiv komparator: Aspirin
Aspirin 2 days
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Arachidonic acid induced platelet aggregation
Tidsramme: up to day 11 (treatment 1), up to day 3 (treatment 2)
|
up to day 11 (treatment 1), up to day 3 (treatment 2)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Antal patienter med bivirkninger
Tidsramme: op til 6 uger
|
op til 6 uger
|
|
Collagen-induced Platelet Aggregation
Tidsramme: up to day 11 (treatment 1), up to day 3 (treatment 2)
|
up to day 11 (treatment 1), up to day 3 (treatment 2)
|
|
Adenosine diphosphate (ADP) Induced Platelet Aggregation
Tidsramme: up to day 11 (treatment 1), up to day 3 (treatment 2)
|
up to day 11 (treatment 1), up to day 3 (treatment 2)
|
|
Serum Thromboxane B2 production
Tidsramme: up to day 11 (treatment 1), up to day 3 (treatment 2)
|
up to day 11 (treatment 1), up to day 3 (treatment 2)
|
|
Number of patients with abnormal changes in laboratory parameters
Tidsramme: up to day 11 (treatment 1), up to day 3 (treatment 2)
|
up to day 11 (treatment 1), up to day 3 (treatment 2)
|
|
Number of patients with abnormal changes in 12-lead electrocardiogram (ECG)
Tidsramme: Screening, 24 hours after the last Aspirin intake
|
Screening, 24 hours after the last Aspirin intake
|
|
Number of patients with clinically significant changes in vital signs
Tidsramme: Screening, 24 hours after the last Aspirin intake
|
Screening, 24 hours after the last Aspirin intake
|
|
Assessment of tolerability on a 4-point scale
Tidsramme: 24 hours after the last Aspirin intake
|
24 hours after the last Aspirin intake
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2002
Primær færdiggørelse (Faktiske)
1. august 2002
Datoer for studieregistrering
Først indsendt
10. juli 2014
Først indsendt, der opfyldte QC-kriterier
10. juli 2014
Først opslået (Skøn)
11. juli 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. juli 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. juli 2014
Sidst verificeret
1. juli 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Blodpladeaggregationshæmmere
- Cyclooxygenase-hæmmere
- Antipyretika
- Cyclooxygenase 2-hæmmere
- Aspirin
- Meloxicam
Andre undersøgelses-id-numre
- 107.255
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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