Arginine Supplementation to Improve Cardiovascular and Endothelial Function After NSAID Treatment

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

A single centre, placebo controlled, blinded (participant, investigator, outcome assessor) trial to evaluate the effects of COX-2 inhibition with celecoxib on endothelial function in healthy male volunteers.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Imperial College London
• Treatments: Celecoxib

Criteria

Inclusion Criteria:

• No abnormal findings on medical history, screening physical examination, hematology, biochemistry, urinalysis (including specific gravity), and vital signs (sitting blood pressure, sitting pulse rate, sitting respiratory rate and body temperature) within 2 weeks of commencement of the study.

• Normal fasting lipid profile

• Non-smoking

• Clear venous access in upper limbs

• BMI: 18-30

• No history or signs of drug abuse

• No other medication 4 weeks before or during the study

• Informed written consent

Exclusion Criteria:

• Any history of allergy to NSAIDS or arginine

• Significant medical conditions

• Pulse rate <50 bpm

• Sitting systolic blood pressure <80 or >160 mmHg

• Sitting diastolic pressure <60 or >100 mmHg

• Baseline endothelial dysfunction (as defined by EndoPAT; LnRHI <0.51)

• Participation in other clinical study 8 weeks before or during the study

• Donation of blood 8 weeks before or during the study

• Those on medication that cannot be discontinued