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

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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

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Meloxicam Drug: Aspirin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : July 2002
Actual Primary Completion Date : August 2002

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Meloxicam/Aspirin
Meloxicam days 1-10 / Aspirin days 5-10
Drug: Meloxicam
Drug: Aspirin
Active Comparator: Aspirin
Aspirin 2 days
Drug: Aspirin



Primary Outcome Measures :
  1. Arachidonic acid induced platelet aggregation [ Time Frame: up to day 11 (treatment 1), up to day 3 (treatment 2) ]

Secondary Outcome Measures :
  1. Collagen-induced Platelet Aggregation [ Time Frame: up to day 11 (treatment 1), up to day 3 (treatment 2) ]
  2. Adenosine diphosphate (ADP) Induced Platelet Aggregation [ Time Frame: up to day 11 (treatment 1), up to day 3 (treatment 2) ]
  3. Serum Thromboxane B2 production [ Time Frame: up to day 11 (treatment 1), up to day 3 (treatment 2) ]
  4. Number of patients with adverse events [ Time Frame: up to 6 weeks ]
  5. Number of patients with abnormal changes in laboratory parameters [ Time Frame: up to day 11 (treatment 1), up to day 3 (treatment 2) ]
  6. Number of patients with abnormal changes in 12-lead electrocardiogram (ECG) [ Time Frame: Screening, 24 hours after the last Aspirin intake ]
  7. Number of patients with clinically significant changes in vital signs [ Time Frame: Screening, 24 hours after the last Aspirin intake ]
  8. Assessment of tolerability on a 4-point scale [ Time Frame: 24 hours after the last Aspirin intake ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02187562     History of Changes
Other Study ID Numbers: 107.255
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
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Aspirin
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Cyclooxygenase 2 Inhibitors