Ulcerative Colitis
Conditions
Keywords
Pharmacokinetics, Aminosalicylates, Mucosal levels, Rectal dialysis
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.
Interventions
PROCEDURERectal dialysis
Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels
Sponsors
Endeavor Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of 5-ASA | 2 weeks after starting Asacol | 5-ASA to be measured using rectal dialysis technique in-vivo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Detected 5-ASA With Change in Ingested Asacol Dose | 5 weeks after starting study | Comparison of 2-week and 5-week 5-ASA as measured thorugh rectal dialysis |
Participant flow
Pre-assignment details
The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Participants by arm
| Arm | Count |
|---|---|
| 1200 mg Asacol Once Daily for 1 Week Rectal dialysis will be done after 1 week on 1200 mg asacol
Rectal dialysis: Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels | 0 |
| 2400 mg Asacol Once Daily for 1 Week Rectal dialysis will be done after 1 week on 2400 mg asacol
Rectal dialysis: Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | The study was terminated and the PI has | 1 | 1 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Detection of 5-ASA
5-ASA to be measured using rectal dialysis technique in-vivo
Time frame: 2 weeks after starting Asacol
Population: The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available
Secondary
Change in Detected 5-ASA With Change in Ingested Asacol Dose
Comparison of 2-week and 5-week 5-ASA as measured thorugh rectal dialysis
Time frame: 5 weeks after starting study
Population: The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available