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Effect of Meloxicam Tablets on Bleeding Time in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02183155
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The primary purpose of this study was to evaluate the effect of meloxicam tablets (7.5, 15 mg and 30 mg) with meloxicam placebo. Extended-release indomethacin capsules (75 mg) was an active control to assess trial sensitivity on bleeding time in healthy subjects. The secondary aim of this study was to assess effects of treatment on other platelet function and coagulation parameters.

Condition or disease Intervention/treatment Phase
Healthy Drug: Meloxicam - low Drug: Meloxicam - medium Drug: Meloxicam - high Drug: Placebo Drug: Extended-release indomethacin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized, Parallel Group Trial to Compare the Effect of Three Doses of Meloxicam Tablets (7.5, 15 and 30 mg) With Placebo on Bleeding Time in Healthy Subjects; With Extended-release Indomethacin Capsules 75 mg (Open-label) as an Active Control to Assess Trial Sensitivity.
Study Start Date : May 2000
Actual Primary Completion Date : September 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Meloxicam - low Drug: Meloxicam - low
Experimental: Meloxicam - medium Drug: Meloxicam - medium
Experimental: Meloxicam - high Drug: Meloxicam - high
Placebo Comparator: Placebo Drug: Placebo
Active Comparator: Extended-release indomethacin Drug: Extended-release indomethacin



Primary Outcome Measures :
  1. Change from baseline in bleeding time [ Time Frame: up to 6 hours post-dose at day 8 ]

Secondary Outcome Measures :
  1. Change from baseline in platelet aggregation [ Time Frame: up to 6 hours post-dose at day 8 ]
  2. Change from baseline in Platelet thromboxane B2 synthesis (TXB2 synthesis) [ Time Frame: up to 6 hours post-dose at day 8 ]
  3. Change in Thromboplastin Time (PT) [ Time Frame: up to 6 hours post-dose at day 8 ]
  4. Change in Activated Partial Thromboplastin Time (APTT) [ Time Frame: up to 6 hours post-dose at day 8 ]
  5. Change in Platelet Count [ Time Frame: up to 6 hours post-dose at day 8 ]
  6. Change in Leucocyte Activation [ Time Frame: Day 1 and 6 hours post-dose at day 8 ]
  7. Plasma levels of meloxicam [ Time Frame: pre-dose, 3 and 6 hours post-dose at day 8 ]
  8. Plasma levels of indomethacin [ Time Frame: pre-dose, 3 and 6 hours post-dose at day 8 ]
  9. Number of patients with adverse events [ Time Frame: up to 8 days ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female subjects between the ages of 18 and 55 years
  • Negative urine pregnancy test on Day1 for females of childbearing potential
  • Weight within +/- 20 percent of ideal weight according to the Metropolitan Life Height and Weight chart
  • Willing and able to cooperate with the investigator and his/her staff
  • Written informed consent in accordance with GCP (Good Clinical Practice) and local legislation

Exclusion Criteria:

  • Any finding, medical condition or dietary restriction that, in the investigator's opinion, may interfere with optimal participation in the study or produce a significant risk to the subject
  • In the opinion of the investigator, the subject has any disease or condition that may result in altered absorption, excess accumulation, or impaired metabolism or excretion of the trial medications
  • A known or suspected hypersensitivity to any of the trial medications or their excipients or any other NSAIDs (Non-Steroid Anti-Inflammatory Drug)
  • A history of gastrointestinal ulcer, perforation or bleeding
  • A history of cerebrovascular bleeding or any other bleeding disorder
  • Women of childbearing potential not using adequate contraception (e.g, intrauterine device, contraceptive pills, Depo-Provera® implant, barrier device) for at least 3 months prior to, and for the duration of trial participation. It should be noted that NSAIDs may interfere with the effectiveness of intrauterine devices
  • History of bronchial asthma
  • Use of any medications that might influence the results of the trial
  • Use of anticoagulants, including warfarin, heparin, ticlopidine, clopidogrel or aspirin
  • Any laboratory value outside the normal range that is considered clinically significant by the investigator. In addition, subjects with the following specific laboratory values will not be allowed:

    • A serum creatinine concentration at baseline > 1.5 mg/dl
    • SGOT (serum glutamic-oxaloacetic transaminase) or SGPT (serum glutamic-pyruvic transaminase) liver enzymes results at baseline > 1.5 times the upper limit of normal
    • A hemoglobin concentration < 10.5 g/dl
    • A white cell count < 3500/mm³
    • A platelet < 100,000/mm³ or a documented abnormal bleeding time, platelet aggregation, thromboxane B2 synthesis, thromboplastin time (PT) or activated partial thromboplastin time (APTT)
  • Inability to refrain from smoking on testing days
  • Participation in another trial with an investigational drug within 30 days of entering the trial
  • Subjects with increased keloid formation
  • Previous surgery of the gastrointestinal tract (except appendectomy)
  • Participation in excessive physical activities (≤ 5 days prior to administration)
  • Current drug or alcohol abuse
  • Small or difficult to locate arm veins that would impair the clinician's ability to draw blood samples
  • Homeopathic medication

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183155     History of Changes
Other Study ID Numbers: 107.236
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Indomethacin
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
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action