Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving Asacol

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04032652
• Other study ID #: EH 11-364
• Status: Terminated
• Phase: Phase 2
• Start date: December 2012
• Est. completion date: December 5, 2014

Study information

• Verified date: September 2019
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 5, 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Ulcerative Colitis

Intervention

Procedure:
• Rectal dialysis
Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels

Drug:
• Rectal dialysis
Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NorthShore University HealthSystem

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of 5-ASA	5-ASA to be measured using rectal dialysis technique in-vivo	2 weeks after starting Asacol
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	5 weeks after starting study