A Study on the Effects of Repeat Doses of Intraject® Sumatriptan on Local Site Signs
Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6 mg sumatriptan. Healthy Individuals will be enrolled for a series of 3 injections over 2 days. Assessment of Local Site Signs will be recorded for up to 5 days, as needed.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single-Center, Open-label, Single-Arm Study to Evaluate the Effects of Repeat Doses of Subcutaneously Delivered Sumatriptan Via the Intraject System of Local Injection Site Signs in Healthy Adult Subjects.|
- The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). [ Time Frame: -15 min, immediately Post-dose, and 1, 4, 8, 24, 48 and 72 hrs post-dose ] [ Designated as safety issue: Yes ]Each of the 18 participants were injected three times (for a total of 54 injections)with Sumavel DosePro, and followed over three days.
|Study Start Date:||December 2007|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
This study will evaluate the extent, persistence, and any cumulative effects on skin tissue by assessing local injection site reactions (bleeding, swelling, erythema, bruising) following repeated administrations of needle-free Intraject sumatriptan to the same anatomic site.