Trial · NCT00538863
Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain
NCT00538863, Phase 3, Completed, INSYS Therapeutics Inc; results first posted 2013-10-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain. Trials, record NCT00538863. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00538863
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain
- NCT number
- NCT00538863
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 319 participants, actual
- Lead sponsor
- INSYS Therapeutics Inc
- Conditions
- Cancer, Pain
- Interventions
- Fentanyl sublingual spray
- First posted
- 2007-10-03
- Last updated
- 2013-10-11
- Results first posted
- 2013-10-11
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients That Experienced 1 or More Adverse Events | Baseline to end of the study (up to 116 days) |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients That Experienced 1 or More Adverse Events | Baseline to end of the study (up to 116 days) | Safety population: All patients who received study medication. | Percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients That Experienced 1 or More Adverse Events | Fentanyl Sublingual Spray Titration | 59.0 | Percentage of patients | ||
| Percentage of Patients That Experienced 1 or More Adverse Events | Fentanyl Sublingual Spray Maintenance | 80.7 | Percentage of patients |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-label Titration | STARTED | Fentanyl Sublingual Spray | 229 | |
| Open-label Titration | COMPLETED | Fentanyl Sublingual Spray | 184 | |
| Open-label Titration | NOT COMPLETED | Fentanyl Sublingual Spray | 45 | |
| Open-label Maintenance | STARTED | Fentanyl Sublingual Spray | 269 | |
| Open-label Maintenance | COMPLETED | Fentanyl Sublingual Spray | 163 | |
| Open-label Maintenance | NOT COMPLETED | Fentanyl Sublingual Spray | 106 |
Source ClinicalTrials.gov
Adverse events232
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Fentanyl Sublingual Spray Titration | 7 | 229 | |
| other | Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Fentanyl Sublingual Spray Maintenance | 65 | 269 | |
| other | Vomiting | Gastrointestinal disorders | Fentanyl Sublingual Spray Titration | 27 | 229 | |
| other | Vomiting | Gastrointestinal disorders | Fentanyl Sublingual Spray Maintenance | 43 | 269 | |
| other | Nausea | Gastrointestinal disorders | Fentanyl Sublingual Spray Titration | 30 | 229 | |
| other | Nausea | Gastrointestinal disorders | Fentanyl Sublingual Spray Maintenance | 28 | 269 | |
| other | Somnolence | Nervous system disorders | Fentanyl Sublingual Spray Titration | 23 | 229 | |
| other | Somnolence | Nervous system disorders | Fentanyl Sublingual Spray Maintenance | 10 | 269 | |
| other | Oedema peripheral | General disorders | Fentanyl Sublingual Spray Titration | 7 | 229 | |
| other | Oedema peripheral | General disorders | Fentanyl Sublingual Spray Maintenance | 31 | 269 |
1 to 10 of 232Source ClinicalTrials.gov
See all 232 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fentanyl Sublingual Spray Titration | ||
| Total, all-cause mortality | Fentanyl Sublingual Spray Maintenance | ||
| Total, other adverse events | Fentanyl Sublingual Spray Titration | 194 | 229 |
| Total, other adverse events | Fentanyl Sublingual Spray Maintenance | 269 | 269 |
| Total, serious adverse events | Fentanyl Sublingual Spray Titration | 33 | 229 |
| Total, serious adverse events | Fentanyl Sublingual Spray Maintenance | 178 | 269 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Fentanyl Sublingual Spray Titration vs Fentanyl Sublingual Spray Maintenance: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00538863
GET https://conductscience.org/api/trials/v1/NCT00538863/events?page=2