Trial · NCT01660763
Efficacy and Safety Trial to Evaluate the Sufentanil NanoTab® PCA System/15 mcg (Zalviso™) for Post-Operative Pain in Patients After Knee or Hip Replacement Surgery
NCT01660763, Phase 3, Completed, Talphera, Inc; results first posted 2014-02-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Trial to Evaluate the Sufentanil NanoTab® PCA System/15 mcg (Zalviso™) for Post-Operative Pain in Patients After Knee or Hip Replacement Surgery. Trials, record NCT01660763. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01660763
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Trial to Evaluate the Sufentanil NanoTab® PCA System/15 mcg (Zalviso™) for Post-Operative Pain in Patients After Knee or Hip Replacement Surgery
- NCT number
- NCT01660763
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 419 participants, actual
- Lead sponsor
- Talphera, Inc
- Conditions
- Post Operative Pain
- Interventions
- Sufentanil NanoTab PCA System/15 mcg, Placebo Sufentanil NanoTab PCA System
- First posted
- 2012-08-09
- Last updated
- 2015-10-20
- Results first posted
- 2014-02-03
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID48). | 48 hours | SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. Range of SPID48 scores were -239 to 417. Time-weighted SPID48 = ∑ \[T(i) - T(i-1)\] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 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 | Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID48). | 48 hours | Units on a scale | LEAST_SQUARES_MEAN |
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 |
|---|---|---|---|---|---|
| Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID48). | Sufentanil NanoTab PCA System/15 mcg | 76.24 | Standard Error 7.02 | Units on a scale | |
| Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID48). | Placebo Sufentanil NanoTab PCA System | -11.35 | Standard Error 10.55 | Units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sufentanil NanoTab PCA System/15 mcg | 315 | |
| Overall Study | STARTED | Placebo Sufentanil NanoTab PCA System | 104 | |
| Overall Study | COMPLETED | Sufentanil NanoTab PCA System/15 mcg | 215 | |
| Overall Study | COMPLETED | Placebo Sufentanil NanoTab PCA System | 43 | |
| Overall Study | NOT COMPLETED | Sufentanil NanoTab PCA System/15 mcg | 100 | |
| Overall Study | NOT COMPLETED | Placebo Sufentanil NanoTab PCA System | 61 |
Source ClinicalTrials.gov
Adverse events56
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 | Confusional State | Psychiatric disorders | Sufentanil NanoTab PCA System/15 mcg | 8 | 315 | |
| other | Confusional State | Psychiatric disorders | Placebo Sufentanil NanoTab PCA System | 1 | 104 | |
| other | Constipation | Gastrointestinal disorders | Sufentanil NanoTab PCA System/15 mcg | 15 | 315 | |
| other | Constipation | Gastrointestinal disorders | Placebo Sufentanil NanoTab PCA System | 1 | 104 | |
| other | Dizziness | Nervous system disorders | Sufentanil NanoTab PCA System/15 mcg | 16 | 315 | |
| other | Dizziness | Nervous system disorders | Placebo Sufentanil NanoTab PCA System | 1 | 104 | |
| other | Dry Mouth | Gastrointestinal disorders | Sufentanil NanoTab PCA System/15 mcg | 4 | 315 | |
| other | Dry Mouth | Gastrointestinal disorders | Placebo Sufentanil NanoTab PCA System | 0 | 104 | |
| other | Headache | Nervous system disorders | Sufentanil NanoTab PCA System/15 mcg | 13 | 315 | |
| other | Headache | Nervous system disorders | Placebo Sufentanil NanoTab PCA System | 6 | 104 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sufentanil NanoTab PCA System/15 mcg | ||
| Total, all-cause mortality | Placebo Sufentanil NanoTab PCA System | ||
| Total, other adverse events | Sufentanil NanoTab PCA System/15 mcg | 171 | 315 |
| Total, other adverse events | Placebo Sufentanil NanoTab PCA System | 35 | 104 |
| Total, serious adverse events | Sufentanil NanoTab PCA System/15 mcg | 8 | 315 |
| Total, serious adverse events | Placebo Sufentanil NanoTab PCA System | 4 | 104 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26079801 | BACKGROUND |
Source PubMed
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 |
|---|
| Sufentanil NanoTab PCA System/15 mcg vs Placebo Sufentanil NanoTab PCA System: 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/NCT01660763
GET https://conductscience.org/api/trials/v1/NCT01660763/events?page=2