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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 Oct 19, 2026, 10:54 AM 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study was to assess the 90-day safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain in subjects on around-the-clock opioids for their persistent 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

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
Dec 2007 (Type not available)
Primary completion
Oct 2010 (Actual)
Completion
Oct 2010 (Actual)
Last update posted
Oct 11, 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 11, 2013 · Synced Oct 19, 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 public registry record, listed eligibility criteria, and available contact information for NCT00538863 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →