The influence of the body on the fate of celecoxib for the prevention of treatment of colorectal cancer: optimization of intestinal sampling for celecoxib in healthy volunteers

Phase 1

• Conditions: Colorectal cancer; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2017-001194-16-BE
• Lead Sponsor: KU Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-24
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Healthy volunteers
age: 20 - 35
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Allergic to celecoxib or NSAID
acute/chronic gastro-intestinal disease
diabetic, cardiovascular disease, pulmonitis, or renal disease
(possible) pregnancy
medicine (contraception excluded)
smoker
HIV, HBV or HVC contamination

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Optimization of intestinal sampling for celecoxib in healthy volunteers;Secondary Objective: Not applicable;Primary end point(s): Optimization of the frequency and volume of enemas to clean the left hemicolon;Timepoint(s) of evaluation of this end point: 01/2019

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): No secundary end points;Timepoint(s) of evaluation of this end point: no timepoint