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

NCT02187562 | Completed Phase 1

• 1 other identifier: 107.255
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Arachidonic acid induced platelet aggregation

  up to day 11 (treatment 1), up to day 3 (treatment 2)

Secondary Outcomes (8)

• Collagen-induced Platelet Aggregation

  up to day 11 (treatment 1), up to day 3 (treatment 2)

• Adenosine diphosphate (ADP) Induced Platelet Aggregation

  up to day 11 (treatment 1), up to day 3 (treatment 2)

• Serum Thromboxane B2 production

  up to day 11 (treatment 1), up to day 3 (treatment 2)

• Number of patients with adverse events

  up to 6 weeks

• Number of patients with abnormal changes in laboratory parameters

  up to day 11 (treatment 1), up to day 3 (treatment 2)

Study Arms (2)

Meloxicam/Aspirin

EXPERIMENTAL

Meloxicam days 1-10 / Aspirin days 5-10

Drug: Meloxicam; Drug: Aspirin

Aspirin

ACTIVE COMPARATOR

Aspirin 2 days

Drug: Aspirin

Interventions

Meloxicam DRUG

Meloxicam/Aspirin

Aspirin DRUG

Aspirin; Meloxicam/Aspirin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Meloxicam; Aspirin

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 11, 2014
• Study Start: July 1, 2002
• Primary Completion: August 1, 2002
• Last Updated: July 14, 2014

Record last verified: 2014-07