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

• Sponsor: NorthShore University HealthSystem (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04032652
• Collaborator: (none)
• Enrollment: 2
• Arms: 2
• Actual Duration (Months): 24.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Procedure: Rectal dialysis; Drug: Rectal dialysis	Phase 2

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
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Dec 5, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1200 mg Asacol once daily for 1 week Rectal dialysis will be done after 1 week on 1200 mg asacol	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
Active Comparator: 2400 mg Asacol once daily for 1 week Rectal dialysis will be done after 1 week on 2400 mg asacol	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

Outcome Measures

Primary Outcome Measures

1. Detection of 5-ASA [2 weeks after starting Asacol]

   5-ASA to be measured using rectal dialysis technique in-vivo

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• NorthShore University HealthSystem

Investigators

• Principal Investigator: Eli D Ehrenpreis, MD, NorthShore University HealthSystem

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: NorthShore University HealthSystem
• ClinicalTrials.gov Identifier: NCT04032652
• Other Study ID Numbers: EH 11-364
• First Posted: Jul 25, 2019
• Last Update Posted: Oct 15, 2019
• Last Verified: Sep 1, 2019

• Keywords provided by NorthShore University HealthSystem: Pharmacokinetics; Aminosalicylates; Mucosal levels; Rectal dialysis
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	1200 mg Asacol Once Daily for 1 Week	2400 mg Asacol Once Daily for 1 Week
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	1	1
COMPLETED	0	0
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	1200 mg Asacol Once Daily for 1 Week	2400 mg Asacol Once Daily for 1 Week	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	Detection of 5-ASA
Description	5-ASA to be measured using rectal dialysis technique in-vivo
Time Frame	2 weeks after starting Asacol

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	1200 mg Asacol Once Daily for 1 Week	2400 mg Asacol Once Daily for 1 Week
Arm/Group Description	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	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
Measure Participants	0	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	1200 mg Asacol Once Daily for 1 Week	2400 mg Asacol Once Daily for 1 Week
Arm/Group Description	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	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
Measure Participants	0	0

Adverse Events

Adverse Event Reporting Description	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, including data about adverse events.
Arm/Group Title	1200 mg Asacol Once Daily for 1 Week		2400 mg Asacol Once Daily for 1 Week
Arm/Group Description	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		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
All Cause Mortality
	1200 mg Asacol Once Daily for 1 Week		2400 mg Asacol Once Daily for 1 Week
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	1200 mg Asacol Once Daily for 1 Week		2400 mg Asacol Once Daily for 1 Week
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	1200 mg Asacol Once Daily for 1 Week		2400 mg Asacol Once Daily for 1 Week
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.