Trial · NCT01539642
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery
NCT01539642, Phase 3, Completed, Talphera, Inc; results first posted 2014-02-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery. Trials, record NCT01539642. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01539642
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery
- NCT number
- NCT01539642
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 172 participants, actual
- Lead sponsor
- Talphera, Inc
- Conditions
- Post-Operative Pain
- Interventions
- Sufentanil NanoTab PCA System/15 mcg, Placebo Sufentanil NanoTab PCA System
- First posted
- 2012-02-27
- 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 (SPID-48). | 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. The range of SPID48 scores were -232 to 326. 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. Note: Active group n=114 and placebo group n=58, instead of active n=115 and placebo n=57, due to one "active" patient receiving placebo inadvertently. |
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 (SPID-48). | 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 (SPID-48). | Sufentanil NanoTab PCA System/15 mcg | 105.60 | Standard Error 10.14 | Units on a scale | |
| Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48). | Placebo Sufentanil NanoTab PCA System | 55.58 | Standard Error 13.11 | 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 | 114 | |
| Overall Study | STARTED | Placebo Sufentanil NanoTab PCA System | 58 | |
| Overall Study | COMPLETED | Sufentanil NanoTab PCA System/15 mcg | 78 | |
| Overall Study | COMPLETED | Placebo Sufentanil NanoTab PCA System | 27 | |
| Overall Study | NOT COMPLETED | Sufentanil NanoTab PCA System/15 mcg | 36 | |
| Overall Study | NOT COMPLETED | Placebo Sufentanil NanoTab PCA System | 31 |
Source ClinicalTrials.gov
Adverse events24
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 | Abdominal Pain | Gastrointestinal disorders | Sufentanil NanoTab PCA System/15 mcg | 0 | 114 | |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo Sufentanil NanoTab PCA System | 1 | 58 | |
| other | Anxiety | Psychiatric disorders | Sufentanil NanoTab PCA System/15 mcg | 2 | 114 | |
| other | Anxiety | Psychiatric disorders | Placebo Sufentanil NanoTab PCA System | 0 | 58 | |
| other | Chest Pain | General disorders | Sufentanil NanoTab PCA System/15 mcg | 0 | 114 | |
| other | Chest Pain | General disorders | Placebo Sufentanil NanoTab PCA System | 1 | 58 | |
| other | Dizziness | Nervous system disorders | Sufentanil NanoTab PCA System/15 mcg | 3 | 114 | |
| other | Dizziness | Nervous system disorders | Placebo Sufentanil NanoTab PCA System | 1 | 58 | |
| other | Hypertension | Vascular disorders | Sufentanil NanoTab PCA System/15 mcg | 1 | 114 | |
| other | Hypertension | Vascular disorders | Placebo Sufentanil NanoTab PCA System | 1 | 58 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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 | 26 | 114 |
| Total, other adverse events | Placebo Sufentanil NanoTab PCA System | 15 | 58 |
| Total, serious adverse events | Sufentanil NanoTab PCA System/15 mcg | 1 | 114 |
| Total, serious adverse events | Placebo Sufentanil NanoTab PCA System | 0 | 58 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25318408 | 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/NCT01539642
GET https://conductscience.org/api/trials/v1/NCT01539642/events?page=2