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.

NCT02183155 Phase 4 COMPLETED

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.

Details

Lead sponsor	Boehringer Ingelheim
Phase	Phase 4
Status	COMPLETED
Enrolment	82
Start date	2000-05

Conditions

• Healthy

Interventions

• Meloxicam - low
• Meloxicam - medium
• Meloxicam - high
• Placebo
• Extended-release indomethacin

Primary outcomes

• Change from baseline in bleeding time — up to 6 hours post-dose at day 8