Back to resultsUse of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving Asacol
Primary Purpose
Ulcerative Colitis
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Rectal dialysis
Rectal dialysis
Sponsored by
About this trial
This is an interventional other trial for Ulcerative Colitis focused on measuring Pharmacokinetics, Aminosalicylates, Mucosal levels, Rectal dialysis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1200 mg Asacol once daily for 1 week
2400 mg Asacol once daily for 1 week
Arm Description
Rectal dialysis will be done after 1 week on 1200 mg asacol
Rectal dialysis will be done after 1 week on 2400 mg asacol
Outcomes
Primary Outcome Measures
Detection of 5-ASA
5-ASA to be measured using rectal dialysis technique in-vivo
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04032652
First Posted
December 4, 2012
Last Updated
September 27, 2019
Sponsor
NorthShore University HealthSystem
1. Study Identification
Unique Protocol Identification Number
NCT04032652
Brief Title
Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving Asacol
Official Title
Measurement of Rectal Levels of 5-aminosalicylic Acid (5-ASA) Using a Novel In-vivo Rectal Dialysis Technique in Healthy Volunteers on Asacol
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
December 2012 (Actual)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 5, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NorthShore University HealthSystem
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Pharmacokinetics, Aminosalicylates, Mucosal levels, Rectal dialysis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1200 mg Asacol once daily for 1 week
Arm Type
Active Comparator
Arm Description
Rectal dialysis will be done after 1 week on 1200 mg asacol
Arm Title
2400 mg Asacol once daily for 1 week
Arm Type
Active Comparator
Arm Description
Rectal dialysis will be done after 1 week on 2400 mg asacol
Intervention Type
Procedure
Intervention Name(s)
Rectal dialysis
Intervention Description
Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels
Intervention Type
Drug
Intervention Name(s)
Rectal dialysis
Intervention Description
Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels
Primary Outcome Measure Information:
Title
Detection of 5-ASA
Description
5-ASA to be measured using rectal dialysis technique in-vivo
Time Frame
2 weeks after starting Asacol
Secondary Outcome Measure Information:
Title
Change in Detected 5-ASA With Change in Ingested Asacol Dose
Description
Comparison of 2-week and 5-week 5-ASA as measured thorugh rectal dialysis
Time Frame
5 weeks after starting study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eli D Ehrenpreis, MD
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22644716
Citation
Stobaugh DJ, Deepak P, Thorpe M, Hannon B, Ehrenpreis ED. Simulated comparison of topical and oral formulations of 5-aminosalicylate for the treatment of ulcerative colitis. Inflamm Bowel Dis. 2013 Feb;19(2):301-8. doi: 10.1002/ibd.23003.
Results Reference
background
PubMed Identifier
12801036
Citation
Reissman P, Ehrenpreis ED, Cohen S, Nogueras JJ, Zaitman D, Wexner SD. Electrolyte profiles within the ileoanal pouch: measurement by an in vivo equilibrium dialysis technique. Dig Liver Dis. 2003 Apr;35(4):251-5. doi: 10.1016/s1590-8658(03)00062-8.
Results Reference
background
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Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving Asacol
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