Effect of Meloxicam Tablets on Bleeding Time in Healthy Subjects

NCT02183155 | Completed Phase 4

• 1 other identifier: 107.236
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in bleeding time

  up to 6 hours post-dose at day 8

Secondary Outcomes (9)

• Change from baseline in platelet aggregation

  up to 6 hours post-dose at day 8

• Change from baseline in Platelet thromboxane B2 synthesis (TXB2 synthesis)

  up to 6 hours post-dose at day 8

• Change in Thromboplastin Time (PT)

  up to 6 hours post-dose at day 8

• Change in Activated Partial Thromboplastin Time (APTT)

  up to 6 hours post-dose at day 8

• Change in Platelet Count

  up to 6 hours post-dose at day 8

Study Arms (5)

Meloxicam - low

EXPERIMENTAL

Drug: Meloxicam - low

Meloxicam - medium

EXPERIMENTAL

Drug: Meloxicam - medium

Meloxicam - high

EXPERIMENTAL

Drug: Meloxicam - high

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Extended-release indomethacin

ACTIVE COMPARATOR

Drug: Extended-release indomethacin

Interventions

Meloxicam - low DRUG

Meloxicam - low

Meloxicam - medium DRUG

Meloxicam - medium

Meloxicam - high DRUG

Meloxicam - high

Placebo DRUG

Placebo

Extended-release indomethacin DRUG

Extended-release indomethacin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 8, 2014
• Study Start: May 1, 2000
• Primary Completion: September 1, 2000
• Last Updated: July 8, 2014

Record last verified: 2014-07