Clinical trial: Effect of Meloxicam Tablets on Bleeding Time in Healthy Subjects (NCT02183155)

Eligibility 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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years.

Patient description (patient's own words): I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL.

Does the patient match the trial criteria? Contradiction