Trial Outcomes & Findings for Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving Asacol (NCT NCT04032652)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

2 weeks after starting Asacol

Results posted on

2019-10-15

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	1	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study The study was terminated and the PI has	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Comparison of 2-week and 5-week 5-ASA as measured thorugh rectal dialysis

Outcome measures

Outcome data not reported

Adverse Events

1200 mg Asacol Once Daily for 1 Week

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2400 mg Asacol Once Daily for 1 Week

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Asst Director Research Compliance

NorthShore University HealthSystem

Phone: 2243647975

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place