Trial Outcomes & Findings for Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection (NCT NCT01570634)
NCT ID: NCT01570634
Last Updated: 2013-03-08
Results Overview
To evaluate the safety and efficacy of CASAD added to the standard-of-care for the therapy of Clostridium difficile infection (C. difficile).
TERMINATED
PHASE2
2 participants
42 days
2013-03-08
Participant Flow
Recruiting was managed by Scott \& White
Participant milestones
| Measure |
Open Label CASAD
Treatment with Calcium Aluminosilicate Anti-Diarrheal (CASAD) for 14 days
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection
Baseline characteristics by cohort
| Measure |
Open Label CASAD
n=2 Participants
Treatment with CASAD for 14 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age Continuous
|
66.8 years
STANDARD_DEVIATION 13.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 42 daysPopulation: The study was terminated early due to slow enrollment. Of the 2 patients enrolled, one took less than 50% of the prescribed study drug. The results are not evaluable.
To evaluate the safety and efficacy of CASAD added to the standard-of-care for the therapy of Clostridium difficile infection (C. difficile).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 daysPopulation: The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.
Compare the number of liquid stools per day during treatment period
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 daysPopulation: The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.
Compare time to resolution of abdominal pain
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 42 daysPopulation: The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.
Compare sustained clinical response
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 42 daysPopulation: The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.
Compare side-effects and complications
Outcome measures
Outcome data not reported
Adverse Events
Open Label CASAD
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open Label CASAD
n=2 participants at risk
Treatment with CASAD for 14 days
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • Adverse events were collected during active study period of 6 weeks.
|
|
Gastrointestinal disorders
Bloating
|
50.0%
1/2 • Number of events 1 • Adverse events were collected during active study period of 6 weeks.
|
|
Gastrointestinal disorders
Burping/Gas
|
50.0%
1/2 • Number of events 1 • Adverse events were collected during active study period of 6 weeks.
|
|
Renal and urinary disorders
Dark urine
|
50.0%
1/2 • Number of events 1 • Adverse events were collected during active study period of 6 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60