Trial Outcomes & Findings for Clinical Trial Comparing JDP-205 to Diphenhydramine Injection for the Treatment of Acute Urticaria (NCT NCT02935699)
NCT ID: NCT02935699
Last Updated: 2019-11-27
Results Overview
Change from baseline to 2 hours in patient-rated pruritus Severity score (values at 2 hours minus Baseline) Patient Pruritus Severity Score Ask the patient "How severely are your hives itching at the moment?" 0 = none 1. = mild (minimal awareness, easily tolerated) 2. = moderate (definite awareness, quite bothersome) 3. = severe (difficult to tolerate)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
262 participants
Primary outcome timeframe
2 hr
Results posted on
2019-11-27
Participant Flow
Participant milestones
| Measure |
Test Drug
JDP-205 Injection, 10 mg/mL, 1 mL
Test Drug (JDP-205): JDP-205 Injection, 10 mg/mL, 1 mL
|
Control
Diphenhydramine Injection, 50 mg/mL, 1 mL
Active Control (Diphenhydramine): Diphenhydramine Injection, 50 mg/mL
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
135
|
|
Overall Study
COMPLETED
|
127
|
135
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial Comparing JDP-205 to Diphenhydramine Injection for the Treatment of Acute Urticaria
Baseline characteristics by cohort
| Measure |
Test Drug
n=127 Participants
JDP-205 Injection, 10 mg/mL, 1 mL
Test Drug (JDP-205): JDP-205 Injection, 10 mg/mL, 1 mL
|
Control
n=135 Participants
Diphenhydramine Injection, 50 mg/mL, 1 mL
Active Control (Diphenhydramine): Diphenhydramine Injection, 50 mg/mL
|
Total
n=262 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 16.28 • n=39 Participants
|
39.2 years
STANDARD_DEVIATION 15.96 • n=41 Participants
|
39.1 years
STANDARD_DEVIATION 16.08 • n=35 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=39 Participants
|
88 Participants
n=41 Participants
|
165 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=39 Participants
|
47 Participants
n=41 Participants
|
97 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
41 Participants
n=39 Participants
|
44 Participants
n=41 Participants
|
85 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=39 Participants
|
62 Participants
n=41 Participants
|
126 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
17 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
41 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
127 participants
n=39 Participants
|
135 participants
n=41 Participants
|
262 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 2 hrPopulation: Intent To Treat population
Change from baseline to 2 hours in patient-rated pruritus Severity score (values at 2 hours minus Baseline) Patient Pruritus Severity Score Ask the patient "How severely are your hives itching at the moment?" 0 = none 1. = mild (minimal awareness, easily tolerated) 2. = moderate (definite awareness, quite bothersome) 3. = severe (difficult to tolerate)
Outcome measures
| Measure |
Test Drug
n=127 Participants
JDP-205 Injection, 10 mg/mL, 1 mL
Test Drug (JDP-205): JDP-205 Injection, 10 mg/mL, 1 mL
|
Control
n=135 Participants
Diphenhydramine Injection, 50 mg/mL, 1 mL
Active Control (Diphenhydramine): Diphenhydramine Injection, 50 mg/mL
|
|---|---|---|
|
Change of Patient Rated Pruritus Score
|
-1.61 score on a scale
Standard Deviation 0.944
|
-1.50 score on a scale
Standard Deviation 0.984
|
SECONDARY outcome
Timeframe: up to 24 hrsPopulation: Intent To Treat Population
Number of patients who needed to return to treatment center approximately 24 hours after discharge
Outcome measures
| Measure |
Test Drug
n=127 Participants
JDP-205 Injection, 10 mg/mL, 1 mL
Test Drug (JDP-205): JDP-205 Injection, 10 mg/mL, 1 mL
|
Control
n=135 Participants
Diphenhydramine Injection, 50 mg/mL, 1 mL
Active Control (Diphenhydramine): Diphenhydramine Injection, 50 mg/mL
|
|---|---|---|
|
Number of Patients Who Needed to Return to Treatment Center
|
7 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: up to 24 hoursPopulation: Intent To Treat Population
Time spent (hours) at the treatment center
Outcome measures
| Measure |
Test Drug
n=127 Participants
JDP-205 Injection, 10 mg/mL, 1 mL
Test Drug (JDP-205): JDP-205 Injection, 10 mg/mL, 1 mL
|
Control
n=135 Participants
Diphenhydramine Injection, 50 mg/mL, 1 mL
Active Control (Diphenhydramine): Diphenhydramine Injection, 50 mg/mL
|
|---|---|---|
|
Time to Discharge
|
1.71 hours
Standard Deviation 0.868
|
2.07 hours
Standard Deviation 1.112
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Intent To Treat Population
Patient Sedation Score at 2 hours Ask the patient "How drowsy do you feel at the moment?" 0 = None (Not drowsy at all) 1. = Mild (Slightly drowsy) 2. = Moderate (Quite drowsy) 3. = Severe (Extremely drowsy)
Outcome measures
| Measure |
Test Drug
n=127 Participants
JDP-205 Injection, 10 mg/mL, 1 mL
Test Drug (JDP-205): JDP-205 Injection, 10 mg/mL, 1 mL
|
Control
n=135 Participants
Diphenhydramine Injection, 50 mg/mL, 1 mL
Active Control (Diphenhydramine): Diphenhydramine Injection, 50 mg/mL
|
|---|---|---|
|
Patient Sedation Scores
|
0.46 score on a scale
Standard Deviation 0.721
|
0.88 score on a scale
Standard Deviation 0.955
|
Adverse Events
Test Drug
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Control
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test Drug
n=127 participants at risk
JDP-205 Injection, 10 mg/mL, 1 mL
Test Drug (JDP-205): JDP-205 Injection, 10 mg/mL, 1 mL
|
Control
n=135 participants at risk
Diphenhydramine Injection, 50 mg/mL, 1 mL
Active Control (Diphenhydramine): Diphenhydramine Injection, 50 mg/mL
|
|---|---|---|
|
Immune system disorders
anaphylactic reaction
|
0.00%
0/127 • 28 days
|
0.74%
1/135 • Number of events 1 • 28 days
|
Other adverse events
| Measure |
Test Drug
n=127 participants at risk
JDP-205 Injection, 10 mg/mL, 1 mL
Test Drug (JDP-205): JDP-205 Injection, 10 mg/mL, 1 mL
|
Control
n=135 participants at risk
Diphenhydramine Injection, 50 mg/mL, 1 mL
Active Control (Diphenhydramine): Diphenhydramine Injection, 50 mg/mL
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/127 • 28 days
|
4.4%
6/135 • 28 days
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/127 • 28 days
|
1.5%
2/135 • 28 days
|
|
Nervous system disorders
Dysgeusia
|
0.79%
1/127 • 28 days
|
0.74%
1/135 • 28 days
|
|
Nervous system disorders
Paraesthesia
|
0.79%
1/127 • 28 days
|
0.00%
0/135 • 28 days
|
|
Nervous system disorders
Presyncope
|
0.79%
1/127 • 28 days
|
0.00%
0/135 • 28 days
|
|
Nervous system disorders
Headache
|
0.79%
1/127 • 28 days
|
0.74%
1/135 • 28 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/127 • 28 days
|
3.0%
4/135 • 28 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.79%
1/127 • 28 days
|
0.00%
0/135 • 28 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/127 • 28 days
|
0.74%
1/135 • 28 days
|
|
Injury, poisoning and procedural complications
Pyrexia
|
0.00%
0/127 • 28 days
|
1.5%
2/135 • 28 days
|
|
Injury, poisoning and procedural complications
Feeling hot
|
0.79%
1/127 • 28 days
|
0.00%
0/135 • 28 days
|
|
Injury, poisoning and procedural complications
Injection site pain
|
0.00%
0/127 • 28 days
|
0.74%
1/135 • 28 days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/127 • 28 days
|
1.5%
2/135 • 28 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/127 • 28 days
|
0.74%
1/135 • 28 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.79%
1/127 • 28 days
|
0.00%
0/135 • 28 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/127 • 28 days
|
0.74%
1/135 • 28 days
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/127 • 28 days
|
0.74%
1/135 • 28 days
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/127 • 28 days
|
0.74%
1/135 • 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place