Trial · NCT00716807
Efficacy of Nalbuphine and Naloxone Administered as Nose Sprays in the Treatment of Orofacial Pain
NCT00716807, Not applicable, Terminated, University of California, San Francisco; results first posted 2013-10-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Nalbuphine and Naloxone Administered as Nose Sprays in the Treatment of Orofacial Pain. Trials, record NCT00716807. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00716807
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Nalbuphine and Naloxone Administered as Nose Sprays in the Treatment of Orofacial Pain
- NCT number
- NCT00716807
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 46 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Temporomandibular Joint Dysfunction Syndrome, Burning Mouth Syndrome
- Interventions
- nalbuphine plus naloxone, nalbuphine plus placebo, nalbuphine plus naloxone, nalbuphine plus placebo
- First posted
- 2008-07-16
- Last updated
- 2016-05-20
- Results first posted
- 2013-10-22
- Limitations and caveats
Dr. Robert Gear led this study and maintained data on his computer. Co-investigators have spent many hours trying to locate data on the deceased investigators' computer, but could find nothing other than the minimal results data entered here.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100. | 20 minute intervals for three hours. |
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 | Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100. | 20 minute intervals for three hours. | Co-investigators have spent many hours with computer-support personnel trying to locate data on the deceased investigators' computer, but could find nothing other than the gender and treatment assignment for 46 enrolled participants. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BMS Nalbuphine + Naloxone | 8 | |
| Overall Study | STARTED | BMS Nalbuphine + Placebo | 5 | |
| Overall Study | STARTED | TMD Nalbuphine + Naloxone | 18 | |
| Overall Study | STARTED | TMD Nalbuphine + Placebo | 15 | |
| Overall Study | COMPLETED | BMS Nalbuphine + Naloxone | 8 | |
| Overall Study | COMPLETED | BMS Nalbuphine + Placebo | 5 | |
| Overall Study | COMPLETED | TMD Nalbuphine + Naloxone | 18 | |
| Overall Study | COMPLETED | TMD Nalbuphine + Placebo | 15 | |
| Overall Study | NOT COMPLETED | BMS Nalbuphine + Naloxone | 0 | |
| Overall Study | NOT COMPLETED | BMS Nalbuphine + Placebo | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BMS Nalbuphine + Naloxone | ||
| Total, all-cause mortality | BMS Nalbuphine + Placebo | ||
| Total, all-cause mortality | TMD Nalbuphine + Naloxone | ||
| Total, all-cause mortality | TMD Nalbuphine + Placebo | ||
| Total, other adverse events | BMS Nalbuphine + Naloxone | 0 | 0 |
| Total, other adverse events | BMS Nalbuphine + Placebo | 0 | 0 |
| Total, other adverse events | TMD Nalbuphine + Naloxone | 0 | 0 |
| Total, other adverse events | TMD Nalbuphine + Placebo | 0 | 0 |
| Total, serious adverse events | BMS Nalbuphine + Naloxone | 0 | 0 |
| Total, serious adverse events | BMS Nalbuphine + Placebo | 0 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DE018526 | Modeling Kappa Opioid Analgesic Mechanisms in Chronic Orofacial Pain Disorders | LEVINE, JON DAVID | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH | 2007 to 2011 |
Source NIH RePORTER
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/NCT00716807
GET https://conductscience.org/api/trials/v1/NCT00716807/registered