Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sumatriptan | Drug | injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Each of the 18 participants were injected three times (for a total of 54 injections)with Sumavel DosePro, and followed over three days. | -15 min, immediately Post-dose, and 1, 4, 8, 24, 48 and 72 hrs post-dose |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patricia Chandler, MD | Covance | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Each of the 18 participants were injected three times (for a total of 54 injections)with Sumavel DosePro, and followed over three days. | Posted | Number | injections | -15 min, immediately Post-dose, and 1, 4, 8, 24, 48 and 72 hrs post-dose | Injections | Injections |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paresthesia | Nervous system disorders | MedDRA 12 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward Smith III, PhD, VP Regulatory Affairs & Product Quality/Safety | Zogenix, Inc | 510 550 8325 | esmith@zogenix.com |
Not provided
| ID | Term |
|---|---|
| D018170 | Sumatriptan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | 1 hr Post-dose | These are the reactions relative to each injection (total of 3 injections in 18 participants). |
| OG003 | 4 hr Post-dose | These are the reactions relative to each injection (total of 3 injections in 18 participants). |
| OG004 | 8 hr Post-dose | These are the reactions relative to each injection (total of 3 injections in 18 participants). |
| OG005 | 24 hr Post-dose | These are the reactions relative to each injection (total of 3 injections in 18 participants). |
| OG006 | 48 hr Post-dose | These are the reactions relative to each injection (total of 3 injections in 18 participants). |
| OG007 | 72 hr Post-dose | 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. |
|
|
| 0 |
| 18 |
| 6 |
| 18 |
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
Not provided
Not provided
| Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |