A Study on the Effects of Repeat Doses of Intraject® Sumatriptan on Local Site Signs (NCT00620425) | Clinical Trial Compass
CompletedPhase 1
A Study on the Effects of Repeat Doses of Intraject® Sumatriptan on Local Site Signs
18 participantsStarted 2007-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 da…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema).
Timeframe: -15 min, immediately Post-dose, and 1, 4, 8, 24, 48 and 72 hrs post-dose