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

Pharmacokinetics of celecoxib for the prevention/treatment of colorectal cancer: optimization of intestinal sampling for celecoxib in healthy volunteers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001194-16-BE

Enrollment

Registered

2017-10-24

Start date

2017-12-11

Completion date

Unknown

Last updated

2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

Trade Name: CELEBREX 200 mg harde capsules Product Name: CELEBREX 200mg harde capsules Product Code: 15L18 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Celecoxib CAS Number: 169590-42-5 Oth

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Secondary end point(s): No secundary end points;Timepoint(s) of evaluation of this end point: no timepoint	—

Countries

Belgium

Contacts

Public ContactDrug Delivery & Disposition

KU Leuven

glenn.lemmens@kuleuven.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026