Trial Outcomes & Findings for A Scintigraphy Study in Adults With Diabetic Gastroparesis (NCT NCT04208698)
NCT ID: NCT04208698
Last Updated: 2021-08-10
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
Baseline to Day 14
Results posted on
2021-08-10
Participant Flow
Two patients entered the Screening Period. No patients were randomized to the Study Treatment Period.
Participant milestones
| Measure |
Screening Period
Screening Period
|
CIN-102 Tablets Dose 1
CIN-102 tablets by mouth twice daily for 14 days
CIN-102 Dose 1: Deuterated domperidone (deudomperidone)
|
Placebo for CIN-102 Dose 1
Placebo tablets by mouth twice daily for 14 days
Placebo for CIN-102: Placebo
|
CIN-102 Dose 2
CIN-102 tablets by mouth twice daily for 14 days
CIN-102 Dose 2: Deuterated domperidone (deudomperidone)
|
Placebo for CIN-102 Dose 2
Placebo tablets by mouth twice daily for 14 days
Placebo for CIN-102: Placebo
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Scintigraphy Study in Adults With Diabetic Gastroparesis
Baseline characteristics by cohort
| Measure |
Screening Period
n=2 Participants
Screening Period
|
CIN-102 Tablets Dose 1
CIN-102 tablets by mouth twice daily for 14 days
CIN-102 Dose 1: Deuterated domperidone (deudomperidone)
|
Placebo for CIN-102 Dose 1
Placebo tablets by mouth twice daily for 14 days
Placebo for CIN-102: Placebo
|
CIN-102 Dose 2
CIN-102 tablets by mouth twice daily for 14 days
CIN-102 Dose 2: Deuterated domperidone (deudomperidone)
|
Placebo for CIN-102 Dose 2
Placebo tablets by mouth twice daily for 14 days
Placebo for CIN-102: Placebo
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
2 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
1 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
—
|
—
|
—
|
—
|
2 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 14Population: No patients were randomized to the study treatment period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening to Day 20Population: No patients were randomized to the study treatment period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Day 14Population: No patients were randomized to the study treatment period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Day 14Population: No patients were randomized to the study treatment period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day -14 to 14Population: No patients were randomized to the study treatment period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day -14 to 14Population: No patients were randomized to the study treatment period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Day 14Population: No patients were randomized to the study treatment period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Day 14Population: No patients were randomized to the study treatment period.
Outcome measures
Outcome data not reported
Adverse Events
CIN-102 Tablets Dose 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo for CIN-102 Dose 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CIN-102 Dose 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo for CIN-102 Dose 2
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60