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Completed Phase 3 Interventional Results available

Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain

ClinicalTrials.gov ID: NCT00538863

Public ClinicalTrials.gov record NCT00538863. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jun 25, 2026, 9:36 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Open-label Multi-center Safety Trial of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain

Study identification

NCT ID
NCT00538863
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
INSYS Therapeutics Inc
Industry
Enrollment
319 participants

Conditions and interventions

Conditions

Interventions

  • Fentanyl sublingual spray Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2007
Primary completion
Sep 30, 2010
Completion
Sep 30, 2010
Last update posted
Oct 10, 2013

2007 – 2010

United States locations

U.S. sites
40
U.S. states
21
U.S. cities
40
Facility City State ZIP Site status
Not listed Huntsville Alabama
Not listed Winfield Alabama
Not listed Glendale Arizona
Not listed Scottsdale Arizona
Not listed Laguna Hills California
Not listed Loma Linda California
Not listed Los Gatos California
Not listed San Mateo California
Not listed Bradenton Florida
Not listed Lake Worth Florida
Not listed Miami Florida
Not listed Winter Park Florida
Not listed Newnan Georgia
Not listed Chicago Illinois
Not listed Skokie Illinois
Not listed Zion Illinois
Not listed Elkhart Indiana
Not listed Bethesda Maryland
Not listed Southfield Michigan
Not listed Edina Minnesota
Not listed Jefferson City Missouri
Not listed Great Falls Montana
Not listed Kalispell Montana
Not listed Missoula Montana
Not listed Voorhees Township New Jersey
Not listed Flat Rock North Carolina
Not listed Winston-Salem North Carolina
Not listed Canton Ohio
Not listed Dayton Ohio
Not listed Eugene Oregon
Not listed Altoona Pennsylvania
Not listed Danville Pennsylvania
Not listed Lemoyne Pennsylvania
Not listed Kingsport Tennessee
Not listed Bellaire Texas
Not listed Dallas Texas
Not listed Fort Worth Texas
Not listed Port Sam Houston Texas
Not listed Tacoma Washington
Not listed Appleton Wisconsin

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00538863, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 10, 2013 · Synced Jun 25, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00538863 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →