Trial · NCT02641340
Fentanyl Sublingual Spray in Opioid Naive Participants
NCT02641340, Phase 1, Completed, INSYS Therapeutics Inc
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fentanyl Sublingual Spray in Opioid Naive Participants. Trials, record NCT02641340. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02641340
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fentanyl Sublingual Spray in Opioid Naive Participants
- NCT number
- NCT02641340
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 96 participants, actual
- Lead sponsor
- INSYS Therapeutics Inc
- Conditions
- Pharmacology
- Interventions
- Fentanyl Sublingual Spray, Fentanyl Citrate IV
- First posted
- 2015-12-29
- Last updated
- 2016-03-30
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum concentration (Cmax) | within 24 hours (see detailed description) | |
| Primary | Time to reach peak or maximum concentration following drug administration (Tmax) | within 24 hours (see detailed description) | |
| Primary | Area under the concentration-time curve | within 24 hours (see detailed description) | Categories: during a dosing interval (AUCtau ), from the time of dosing to infinity (AUC0-inf), from the time of dosing to the last quantifiable time point (AUC0-t) |
| Primary | Apparent elimination rate constant in the terminal phase by non-compartmental analysis | within 24 hours (see detailed description) | |
| Primary | Corresponding half-life (t1/2) | within 24 hours (see detailed description) | |
| Primary | Trough concentration during multiple dosing prior to next dose (Ctrough) | within 24 hours (see detailed description) | |
| Primary | Accumulation ratios | within 24 hours (see detailed description) | Categories: of Cmax (ARcmax), based on trough concentration (ARctrough), of AUCtau (ARauctau) |
| Primary | Dose normalized Cmax | within 24 hours (see detailed description) | |
| Primary | Dose normalized AUC | within 24 hours (see detailed description) | Categories: AUC0-1, AUC0-inf, AUCtau |
| Secondary | Participants with respiratory depression requiring the use of naloxone | within 24 hours |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02641340
GET https://conductscience.org/api/trials/v1/NCT02641340/registered