Trial Outcomes & Findings for Study of Promethazine for Treatment of Diabetic Gastroparesis (NCT NCT02130622)
NCT ID: NCT02130622
Last Updated: 2018-08-07
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
4 weeks
Results posted on
2018-08-07
Participant Flow
Participants were recruited from the gastroenterology clinic at Dartmouth-Hitchcock Medical Center at the time of routine appointments.
Participant milestones
| Measure |
Promethazine
Promethazine 12.5 mg P.O. t.i.d. for 4 weeks
Promethazine
|
Sugar Pill
Placebo P.O. t.i.d. for 4 weeks
Sugar pill
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Promethazine for Treatment of Diabetic Gastroparesis
Baseline characteristics by cohort
| Measure |
Promethazine
n=2 Participants
Promethazine 12.5 mg P.O. t.i.d. for 4 weeks
Promethazine
|
Sugar Pill
n=1 Participants
Placebo P.O. t.i.d. for 4 weeks
Sugar pill
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Insufficient recruitment resulting in insufficient data to analyze
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: Insufficient recruitment resulting in insufficient data to analyze
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: Data not collected
Frequency of use of the "rescue medication" meclizine
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: Insufficient recruitment resulting in insufficient data to analyze
Outcome measures
Outcome data not reported
Adverse Events
Promethazine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Promethazine
n=2 participants at risk
Promethazine 12.5 mg P.O. t.i.d. for 4 weeks
Promethazine
|
Sugar Pill
n=1 participants at risk
Placebo P.O. t.i.d. for 4 weeks
Sugar pill
|
|---|---|---|
|
Psychiatric disorders
Auditory Hallucinations
|
50.0%
1/2 • Number of events 2 • From date of ICF signature through study completion, approximately 5 weeks
|
0.00%
0/1 • From date of ICF signature through study completion, approximately 5 weeks
|
|
Psychiatric disorders
Nightmares
|
50.0%
1/2 • Number of events 3 • From date of ICF signature through study completion, approximately 5 weeks
|
0.00%
0/1 • From date of ICF signature through study completion, approximately 5 weeks
|
|
Cardiac disorders
Chest Pain
|
50.0%
1/2 • Number of events 1 • From date of ICF signature through study completion, approximately 5 weeks
|
0.00%
0/1 • From date of ICF signature through study completion, approximately 5 weeks
|
Additional Information
Gastroenterology Research Team Lead
Dartmouth-Hitchcock
Phone: 603-653-9033
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place