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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zogenix, Inc.
ClinicalTrials.gov Identifier:
NCT00620425
First received: January 2, 2008
Last updated: July 16, 2012
Last verified: July 2012
  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 Intervention Phase
Healthy
Drug: Sumatriptan
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Zogenix, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Each of the 18 participants were injected three times (for a total of 54 injections)with Sumavel DosePro, and followed over three days.


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)
Intervention Details:
    Drug: Sumatriptan
    injection
    Other Name: SUMAVEL(R) DosePro(R)
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
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620425

Sponsors and Collaborators
Zogenix, Inc.
Investigators
Principal Investigator: Patricia Chandler, MD Covance
  More Information

No publications provided

Responsible Party: Zogenix, Inc.
ClinicalTrials.gov Identifier: NCT00620425     History of Changes
Other Study ID Numbers: ZX001-0703
Study First Received: January 2, 2008
Results First Received: November 1, 2010
Last Updated: July 16, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Sumatriptan
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014