Trial Outcomes & Findings for CASAD for Severe Diarrhea in the Emergency Department (NCT NCT02018653)

Results Overview

The primary endpoint is time to resolution of diarrhea (TTRD) defined as the time of the bowel movement that is not followed by another bowel movement within 8 hours. Participants will be evaluated for the primary endpoint for up to 6 days.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

6 days

Results posted on

2018-07-26

Participant Flow

Recruitment Period: December 16, 2013 to August 1, 2014. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Clinical trial closed due to slow accrual.

Participant milestones

Participant milestones
Measure	Calcium Alumina-Silicate (CASAD) CASAD 1 gram orally every 6 hours for up to 6 days.	Placebo Placebo orally every 6 hours for up to 6 days.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CASAD for Severe Diarrhea in the Emergency Department

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Calcium Alumina-Silicate (CASAD) n=1 Participants CASAD 1 gram orally every 6 hours for up to 6 days.	Placebo n=1 Participants Placebo orally every 6 hours for up to 6 days.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Region of Enrollment United States	1 participants n=99 Participants	1 participants n=107 Participants	2 participants n=206 Participants

PRIMARY outcome

Timeframe: 6 days

Population: Too few subjects enrolled to make any conclusions.

The primary endpoint is time to resolution of diarrhea (TTRD) defined as the time of the bowel movement that is not followed by another bowel movement within 8 hours. Participants will be evaluated for the primary endpoint for up to 6 days.

Outcome measures

Outcome measures
Measure	Calcium Alumina-Silicate (CASAD) n=1 Participants CASAD 1 gram orally every 6 hours for up to 6 days.	Placebo n=1 Participants Placebo orally every 6 hours for up to 6 days.
Time to Resolution of Diarrhea (TTRD)	48 hours	96 hours

Adverse Events

Calcium Alumina-Silicate (CASAD)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Sai-Ching J. Yeung, MD

University of Texas (UT) MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place