Trial Outcomes & Findings for A Study on the Effects of Repeat Doses of Intraject® Sumatriptan on Local Site Signs (NCT NCT00620425)
NCT ID: NCT00620425
Last Updated: 2023-05-09
Results Overview
Each of the 18 participants were injected three times (for a total of 54 injections)with Sumavel DosePro, and followed over three days.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
-15 min, immediately Post-dose, and 1, 4, 8, 24, 48 and 72 hrs post-dose
Results posted on
2023-05-09
Participant Flow
Participant milestones
| Measure |
All Participants
Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study on the Effects of Repeat Doses of Intraject® Sumatriptan on Local Site Signs
Baseline characteristics by cohort
| Measure |
All Participants
n=18 Participants
Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: -15 min, immediately Post-dose, and 1, 4, 8, 24, 48 and 72 hrs post-doseEach of the 18 participants were injected three times (for a total of 54 injections)with Sumavel DosePro, and followed over three days.
Outcome measures
| Measure |
48 hr Post-dose
n=39 Injections
These are the reactions relative to each injection (total of 3 injections in 18 participants).
|
All Participants at -15 Min Pre-dose
n=54 Injections
Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
|
All Participants Immediately Post-dose
n=54 Injections
These are the reactions relative to each injection (total of 3 injections in 18 participants).
|
1 hr Post-dose
n=54 Injections
These are the reactions relative to each injection (total of 3 injections in 18 participants).
|
4 hr Post-dose
n=54 Injections
These are the reactions relative to each injection (total of 3 injections in 18 participants).
|
8 hr Post-dose
n=54 Injections
These are the reactions relative to each injection (total of 3 injections in 18 participants).
|
24 hr Post-dose
n=54 Injections
These are the reactions relative to each injection (total of 3 injections in 18 participants).
|
72 hr Post-dose
n=6 Injections
Only 3 subjects were required to return on Day 4. Day 4 assessments included a 72 hour assessment for the first and second injections and a 48 hour assessment for the third injection.
|
|---|---|---|---|---|---|---|---|---|
|
The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema).
Injections with Bleeding present
|
0 injections
|
0 injections
|
51 injections
|
0 injections
|
0 injections
|
0 injections
|
0 injections
|
0 injections
|
|
The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema).
Injections with Bruising present
|
10 injections
|
0 injections
|
0 injections
|
0 injections
|
1 injections
|
3 injections
|
4 injections
|
1 injections
|
|
The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema).
Injections with Swelling present
|
0 injections
|
0 injections
|
39 injections
|
18 injections
|
0 injections
|
0 injections
|
0 injections
|
0 injections
|
|
The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema).
Injections with Erythema present
|
2 injections
|
0 injections
|
9 injections
|
39 injections
|
37 injections
|
18 injections
|
13 injections
|
0 injections
|
Adverse Events
All Participants
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants
n=18 participants at risk
Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
|
|---|---|
|
Nervous system disorders
Paresthesia
|
33.3%
6/18 • Number of events 6
|
|
Nervous system disorders
Headache
|
22.2%
4/18 • Number of events 4
|
Additional Information
Edward Smith III, PhD, VP Regulatory Affairs & Product Quality/Safety
Zogenix, Inc
Phone: 510 550 8325
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place