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A Study on the Effects of Repeat Doses of Intraject® Sumatriptan on Local Site Signs
This study has been completed.
First Received: January 2, 2008   Last Updated: February 20, 2008   History of Changes
Sponsor: Zogenix, Inc.
Information provided by: Zogenix, Inc.
ClinicalTrials.gov Identifier: NCT00620425
  Purpose

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
Healthy

Study Type: Observational
Study Design: Cohort, Prospective
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.

Resource links provided by NLM:


Further study details as provided by Zogenix, Inc.:

Primary Outcome Measures:
  • To 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 Intraject sumatriptan to the same anatomic site. [ Time Frame: one week ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment: 18
Study Start Date: December 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Study Population

Healthy Volunteer Subjects

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Zogenix, Inc ( Stephen J. Farr, Ph.D/ President and COO )
Study ID Numbers: ZX001-0703
Study First Received: January 2, 2008
Last Updated: February 20, 2008
ClinicalTrials.gov Identifier: NCT00620425     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Zogenix, Inc.:
sumatriptan
Intraject
Local Site Reactions

Additional relevant MeSH terms:
Serotonin Agonists
Sumatriptan
Neurotransmitter Agents
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Vasoconstrictor Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010