Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 87 for:    ASPIRIN AND thromboxane

Effect of Steady State Meloxicam on Low Dose Aspirin Induced Inhibition of Platelet Aggregation and Thromboxane Synthesis in Healthy Males and Females

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02187562
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE July 10, 2014
First Posted Date  ICMJE July 11, 2014
Last Update Posted Date July 14, 2014
Study Start Date  ICMJE July 2002
Actual Primary Completion Date August 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
Arachidonic acid induced platelet aggregation [ Time Frame: up to day 11 (treatment 1), up to day 3 (treatment 2) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02187562 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Steady State Meloxicam on Low Dose Aspirin Induced Inhibition of Platelet Aggregation and Thromboxane Synthesis in Healthy Males and Females
Official Title  ICMJE 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.
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Meloxicam
  • Drug: Aspirin
Study Arms  ICMJE
  • Experimental: Meloxicam/Aspirin
    Meloxicam days 1-10 / Aspirin days 5-10
    Interventions:
    • Drug: Meloxicam
    • Drug: Aspirin
  • Active Comparator: Aspirin
    Aspirin 2 days
    Intervention: Drug: Aspirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2014)
16
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02187562
Other Study ID Numbers  ICMJE 107.255
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP