Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00620425
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : July 17, 2012
Last Update Posted : July 17, 2012
Information provided by (Responsible Party):
Zogenix, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Sumatriptan Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : December 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Sumatriptan

Intervention Details:
  • Drug: Sumatriptan
    Other Name: SUMAVEL(R) DosePro(R)

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00620425

Sponsors and Collaborators
Zogenix, Inc.
Layout table for investigator information
Principal Investigator: Patricia Chandler, MD Covance

Layout table for additonal information
Responsible Party: Zogenix, Inc. Identifier: NCT00620425     History of Changes
Other Study ID Numbers: ZX001-0703
First Posted: February 21, 2008    Key Record Dates
Results First Posted: July 17, 2012
Last Update Posted: July 17, 2012
Last Verified: July 2012
Keywords provided by Zogenix, Inc.:
Local Site Reactions
Additional relevant MeSH terms:
Layout table for MeSH terms
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs