Measurement of Rectal Levels of 5-aminosalicylic Acid (5-ASA) Using a Novel In-vivo Rectal Dialysis Technique in Healthy Volunteers on Asacol
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 2
- Primary Endpoint
- Detection of 5-ASA
Study Overview
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 optimal dosing of Asacol® that would provide therapeutic levels of 5-ASA in the left colon.
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 terminal ileum and throughout the colon; hence, it would be anticipated that this form of 5-ASA will produce higher concentrations in the left colon in patients with active ulcerative colitis compared to other immediate release forms of 5-ASA. However, preliminary research using dynamic computer modeling and simulation predicted that patients with active ulcerative colitis (characterized by an increased stool frequency) treated with Asacol® and Lialda (another delayed release formulation) will achieve very low 5-ASA levels in the sigmoid colon and rectum. The model predicts that these 5-ASA preparations will be relatively ineffective in treating the left side of the colon in active ulcerative colitis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
1200 mg Asacol once daily for 1 week
Rectal dialysis will be done after 1 week on 1200 mg asacol
Intervention: Rectal dialysis (Drug)
2400 mg Asacol once daily for 1 week
Rectal dialysis will be done after 1 week on 2400 mg asacol
Intervention: Rectal dialysis (Drug)
Outcomes
Primary Outcomes
Detection of 5-ASA
Time Frame: 2 weeks after starting Asacol
5-ASA to be measured using rectal dialysis technique in-vivo
Secondary Outcomes
- Change in Detected 5-ASA With Change in Ingested Asacol Dose(5 weeks after starting study)