Randomised controlled trial of 6-Mercaptopurine versus placebo to prevent recurrence of Crohn's disease following surgical resectio

Phase 1

• Conditions: Crohn's Disease; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2006-005800-15-GB
• Lead Sponsor: niversity of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-01
• Study Completion: 2015-09-30
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

1. At least 16 years of age in Scotland and 18 years of age in England and Wales. 2. Established diagnosis of Crohn’s disease confirmed at recent resection. 3. Ileocolonic or small bowel resection within 3 months before screening. 4. No more than 100 cm of fixed small bowel resected in total. Previous ileocolonic resection is acceptable. 5. Able to start oral nutrition within the first 2 postoperative weeks. 6. Normal or heterozygous TPMT (activity present or reduced consistent with carrier status). 7. Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol. 8. Off antibiotics 2 weeks prior to randomisation.
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Pregnancy at baseline or breast feeding. 2. A known hypersensitivity or intolerance to 6MP. 3. Pancreatitis associated with azathioprine. 4. Receiving an experimental treatment for Crohn’s disease in the 4 weeks prior to study entry. 5. Known to require further surgery at study entry i.e. for the removal of an abscess developing from the primary surgery. 6. Stricturoplasty procedure alone (Please note that stricturoplasty and resection procedure together will not be considered an exclusion.) 7. Presence of stoma. 8. Significant haematological, renal or hepatic dysfunction or clinically important lung disease (i.e. liver function tests >x2 upper limit of normal, Haemoglobin =10, total white blood cell count <3.5, Neutrophils <1.5, Platelets <100x106/l). 9. Systemic infection including hepatitis B, hepatitis C, HIV and active TB. 10. A diagnosis of indeterminate colitis or ulcerative colitis. 11. A history of illicit drug or alcohol abuse in the 1 year prior to study entry. 12. Active or untreated malignancy (excluding basal cell carcinoma and insitu tumours). (Patients who have had successful treatment for malignancy and have been in remission for more than 5 years may be considered for inclusion only after detailed discussion with, and written approval, from the patient's medical oncologist.) 13. Presence of a medical or psychiatric condition, disease or laboratory abnormality that in the opinion of the PI may place the subject at unacceptable risk during the study. 14. Homozygous deficient for TPMT (absent activity) 15. Evidence of untreated post-operative infection e.g. clostridium difficile, urinary tract infection or chest infection. If these have been appropriately treated in the opinion of the PI, and inclusion criteria 8 is met, this will not be considered an exclusion.

Study & Design

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