Phase 1
N=18
A Study on the Effects of Repeat Doses of Intraject® Sumatriptan on Local Site Signs
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00620425 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcome: Primary: The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). — 0; 51; 0; 0 injections
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Sumatriptan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zogenix, Inc.
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). |
0; 51; 0; 0; 0; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Female subjects of child-bearing potential must agree to use acceptable birth control
- Have abdominal or thigh injection sites that have sufficient subcutaneous tissue for needle-free injection
- Fluent in the spoken and written English language
- Provide written informed consent to participate in the study and be willing to comply with the study procedures
- Non-tobacco user for at least 12 months prior to screening (all types of tobacco, including cigars)
Exclusion Criteria
- A history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes including ischemic or vasospastic coronary artery disease
- Other significant underlying cardiovascular diseases including uncontrolled hypertension
- Hemiplegic or basilar migraine
- A history or diagnosis of severe hepatic or renal impairment
- A history of epilepsy or seizure or other serious neurologic condition
- A history of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its components or similar drugs
- A history of scleroderma (systemic sclerosis) or any skin condition that may adversely affect the injection or absorption of subcutaneously administered medications
- Tattoos, birthmarks or other significant skin discoloration in the thigh or abdominal area that are large enough to restrict injection site selection and/or evaluation
- Pregnancy or breast-feeding
- Have participated in a clinical trial or receipt of an experimental therapy within 30 days prior to dosing
Data sourced from ClinicalTrials.gov (NCT00620425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.