HealthyPhase 1NCT00620425

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

A Phase 1 study testing Sumatriptan in people with Healthy, run by Zogenix, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Sumatriptan
Type of treatment: Injection or infusion
How many people: 18 participants
Where: No sites listed yet
Study dates: Dec 2007to Dec 2007
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 10Show fewer

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

About this study

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.

Read the detailed description

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.

Conditions: Healthy
Being tested: Sumatriptan
Keywords: sumatriptan, Intraject, Local Site Reactions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SumatriptanDrug
Also called SUMAVEL(R) DosePro(R)
injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: -15 min, immediately Post-dose, and 1, 4, 8, 24, 48 and 72 hrs post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007Dec 2007

First posted21 Feb 2008 (estimated)
Study startDec 2007
Primary completionDec 2007
Study completionDec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00620425
Sponsor's protocol ID: ZX001-0703
Status last verified: May 2023
First submitted: 2 Jan 2008
Last updated: 9 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00620425
Acronym / sponsor ID: ZX001-0703
Conditions: Healthy
Keywords: sumatriptan, Intraject, Local Site Reactions
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Zogenix, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 21 Feb 2008 (estimated)
Results: Posted 17 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SumatriptanAlso: SUMAVEL(R) DosePro(R)injection	Drug	–

Primary outcome

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
Each of the 18 participants were injected three times (for a total of 54 injections)with Sumavel DosePro, and followed over three days.

Results and safety

Results posted to the registry on 17 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	18	18

Primary outcome: 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. Number. Unit: injections

Measure	All Participants Immediately Post-dose n = 18	1 hr Post-dose n = 18	4 hr Post-dose n = 18	8 hr Post-dose n = 18	24 hr Post-dose n = 18	48 hr Post-dose n = 18	72 hr Post-dose n = 3
Injections with Bleeding present	51	0	0	0	0	0	0
Injections with Bruising present	0	0	1	3	4	10	1
Injections with Swelling present	39	18	0	0	0	0	0
Injections with Erythema present	9	39	37	18	13	2	0

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 18 (0%)	6 of 18 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patricia Chandler, MD principal investigator

Covance

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sumatriptan in people with Healthy, run by Zogenix, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00620425.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.