Evaluation of Ultrasound with Mesalazine Enema
Not Applicable
Completed
- Conditions
- ulcerative colitisOral and Gastrointestinal - Inflammatory bowel disease
- Registration Number
- ACTRN12622001247763
- Lead Sponsor
- Suono Bio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
* Undergoing routine colonoscopy procedure
* Signed informed consent
Exclusion Criteria
* Current known presentation of hemorrhoids or rectal bleeding
* Pregnant or breast feeding
* History of salicylate allergy
* Previous bowel resection
* Clinically significant hepatic or renal disease
* Participating in a clinical trial within 1 month
* History or signs of IBD (Crohn’s disease, UC) or cancer
* Insufficient / no preparation for colonoscopy
* Currently taking 5-ASA based oral medication
* Currently taking anti-coagulants or anti-platelet agents
* Currently taking glucocorticoids, sulphonylureas, methotrexate, probenecid/sulphinpyrazone, spironolactone/frusemide, rifampicin, azathioprine, mercaptopurine or thioguanine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine safety and tolerability of rectal ultrasound in combination with an approved topical mesalazine enema measured by gross examinations of tissue during colonoscopy and histological examinations (Hematoxylin & Eosin [H&E] stain) of biopsied colon tissue.[ Day of procedure];To determine safety and tolerability of rectal ultrasound in combination with an approved topical mesalazine enema measured by analysis of blood for complete blood count with differential, comprehensive metabolic panel, and systemic drug levels pre- and post-treatment.[ Baseline and day of procedure];To determine tolerability of rectal ultrasound in combination with an approved topical mesalazine enema measured by participant and clinician feedback. Feedback will be collected using a study specific questionnaire containing open ended questions and 10 point likert scales.[ Day of procedure]
- Secondary Outcome Measures
Name Time Method To determine the concentration of mesalazine in colon tissue biopsies.[ Day of procedure];Capture treatment-emergent adverse events (TEAEs) during and immediately after the procedure and a follow up call. All adverse events will be recorded on case report forms. Potential adverse events could include anal discomfort or pain, mucosal erythema, abrasion, or bleeding.[ Day of procedure and 3-7 days post treatment follow up call]