Trial Outcomes & Findings for Single Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDY (NCT NCT02665221)
NCT ID: NCT02665221
Last Updated: 2018-01-18
Results Overview
TERMINATED
PHASE4
30 participants
6 Hours
2018-01-18
Participant Flow
Participant milestones
| Measure |
Control Group
No Treatment Arm: Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.
|
Treatment Group
Topical Preparation H arm: Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Center, Open Label, Study of Preparation H on Erythema in Relapsing MS Patients Treated With PLEGRIDY
Baseline characteristics by cohort
| Measure |
Control Group
n=15 Participants
No Treatment Arm: Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.
|
Treatment Group
n=15 Participants
Topical Preparation H arm: Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.
|
Total
n=30 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
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 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
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 HoursPopulation: Study was terminated. Logpad used by subjects was defective and data was not collected. No data analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 HoursPopulation: Study was terminated. Logpad used by subjects was defective and data was not collected. No data analyzed.
Study was terminated. No data analyzed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 HoursPopulation: Study was terminated. No data analyzed. Study was terminated. No data analyzed because the Logpad being used by subjects was flawed.
Study was terminated. No data analyzed. Study was terminated. No data analyzed because the Logpad being used by subjects was flawed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 HoursPopulation: Study was terminated. Logpad used by subjects was defective and data was not collected. No data analyzed.
Study was terminated. No data analyzed because the Logpad being used by subjects was flawed.
Outcome measures
Outcome data not reported
Adverse Events
Control Group
Treatment Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Shannon Haas
MS Comprehensive Care Center NYU Langone Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place