Status:
TERMINATED
Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving Asacol
Lead Sponsor:
Endeavor Health
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
The investigators plan to develop a novel method of estimating 5-ASA levels in the rectum at a mucosal level using in vivo rectal dialysis technique towards the eventual goal of determining the optima...
Detailed Description
Asacol® is mesalazine in a pH-dependent tablet (Eudragit S) that remains intact until reaching the terminal ileum. The tablet dissolves at a pH 7 or greater, allowing mesalazine release in the termina...
Eligibility Criteria
Inclusion
- Eligible subjects would be healthy males and females
- 18-45 years of age (inclusive)
- Within 20% of normal body weight at screening
- Who are able to give written informed consent.
Exclusion
- History of any chronic illness
- Evidence of significant organic or psychiatric disease on a brief health questionnaire
- A history or presence of any condition causing malabsorption or an effect on gastrointestinal motility
- A history of any gastrointestinal surgery
- A history of acute or chronic renal insufficiency
- Pre existing liver disease
- A history of severe allergic reaction to salicylates, aminosalicylates or any of the ingredients of Asacol® tablets or a history of multiple food/drug allergies or if they are pregnant or lactating.
- Subjects will be required to refrain from any prescription or nonprescription drug or herbal products except their birth control medications for gastrointestinal disorders for 7 days prior to dosing and during the study, till its completion at the end of the fifth visit.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04032652
Start Date
December 1 2012
End Date
December 5 2014
Last Update
October 15 2019
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