Rectal and blood concentrations of thioguanine given by suppository in inflammatory bowel disease

Phase 1

• Conditions: inflammatory Bowel Disease; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12623001337662
• Lead Sponsor: Douglas Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-19
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Patients with refractory ulcerative proctitis

Exclusion Criteria

Unable to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in inflammatory bowel disease symptoms[Simple Clinical Colitis Activity Index (SCCAI) questionnaire SCCAI at days 1, 8, 15, 22, and 29 post-commencement of thioguanine suppositories.];Improvement in colitis activity determined by endoscopic appearance[Flexible sigmoidoscopy Day 29]

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics including AUC, Cmax, Tmax, Clearance and half-life[Blood and rectal tissue samples Blood samples drawn at 30 min, 1, 2, 4, and 6 hours post thioguanine suppository administration and days 1 and 29.<br>Flexible sigmoidoscopy for disease activity by Mayo and UCEIS (ulcerative colitis endoscopic index of severity) scores at baseline and on day 29.]