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A Study on the Effects of Repeat Doses of Intraject® Sumatriptan on Local Site Signs

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ClinicalTrials.gov Identifier: NCT00620425
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : July 17, 2012
Last Update Posted : July 17, 2012
Sponsor:
Information provided by (Responsible Party):
Zogenix, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Intervention Drug: Sumatriptan
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Participants
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 18
Completed 18
Not Completed 0
Arm/Group Title All Participants
Hide Arm/Group Description 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 Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
31  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
13
  72.2%
Male
5
  27.8%
1.Primary Outcome
Title The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema).
Hide Description Each of the 18 participants were injected three times (for a total of 54 injections)with Sumavel DosePro, and followed over three days.
Time Frame -15 min, immediately Post-dose, and 1, 4, 8, 24, 48 and 72 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants at -15 Min Pre-dose All Participants Immediately Post-dose 1 hr Post-dose 4 hr Post-dose 8 hr Post-dose 24 hr Post-dose 48 hr Post-dose 72 hr Post-dose
Hide Arm/Group Description:
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.
These are the reactions relative to each injection (total of 3 injections in 18 participants).
These are the reactions relative to each injection (total of 3 injections in 18 participants).
These are the reactions relative to each injection (total of 3 injections in 18 participants).
These are the reactions relative to each injection (total of 3 injections in 18 participants).
These are the reactions relative to each injection (total of 3 injections in 18 participants).
These are the reactions relative to each injection (total of 3 injections in 18 participants).
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.
Overall Number of Participants Analyzed 18 18 18 18 18 18 18 3
Overall Number of Units Analyzed
Type of Units Analyzed: Injections
54 54 54 54 54 54 39 6
Measure Type: Number
Unit of Measure: injections
Injections with Bleeding present 0 51 0 0 0 0 0 0
Injections with Bruising present 0 0 0 1 3 4 10 1
Injections with Swelling present 0 39 18 0 0 0 0 0
Injections with Erythema present 0 9 39 37 18 13 2 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants
Hide Arm/Group Description 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-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%) # Events
Total   0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Participants
Affected / at Risk (%) # Events
Total   6/18 (33.33%)    
Nervous system disorders   
Paresthesia  1  6/18 (33.33%)  6
Headache  2  4/18 (22.22%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
2
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Edward Smith III, PhD, VP Regulatory Affairs & Product Quality/Safety
Organization: Zogenix, Inc
Phone: 510 550 8325
EMail: esmith@zogenix.com
Layout table for additonal information
Responsible Party: Zogenix, Inc.
ClinicalTrials.gov Identifier: NCT00620425     History of Changes
Other Study ID Numbers: ZX001-0703
First Submitted: January 2, 2008
First Posted: February 21, 2008
Results First Submitted: November 1, 2010
Results First Posted: July 17, 2012
Last Update Posted: July 17, 2012