Trial · NCT01539538

A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain

NCT01539538, Phase 3, Completed, Talphera, Inc; results first posted 2014-03-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain. Trials, record NCT01539538. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01539538

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain
NCT number: NCT01539538
Status: Completed
Phases: Phase 3
Enrollment: 357 participants, actual
Lead sponsor: Talphera, Inc
Conditions: Post-Operative Pain
Interventions: Sufentanil NanoTab PCA System/15 mcg, morphine IV PCA
First posted: 2012-02-27
Last updated: 2015-10-01
Results first posted: 2014-03-27

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Patient Global Satisfaction	48 hours	Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control

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	Patient Global Satisfaction	48 hours		% patients reporting good or excellent	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
Patient Global Satisfaction	Sufentanil NanoTab PCA System/15 mcg		78.5	95% Confidence Interval 72.5 to 84.6	% patients reporting good or excellent
Patient Global Satisfaction	Morphine IV PCA		65.6	95% Confidence Interval 58.6 to 72.5	% patients reporting good or excellent

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sufentanil NanoTab PCA System/15 mcg	177
Overall Study	STARTED	Morphine IV PCA	180
Overall Study	COMPLETED	Sufentanil NanoTab PCA System/15 mcg	146
Overall Study	COMPLETED	Morphine IV PCA	136
Overall Study	NOT COMPLETED	Sufentanil NanoTab PCA System/15 mcg	31
Overall Study	NOT COMPLETED	Morphine IV PCA	44

Source ClinicalTrials.gov

Adverse events96

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
other	nausea	Gastrointestinal disorders	Sufentanil NanoTab PCA System/15 mcg	76	177
other	nausea	Gastrointestinal disorders	Morphine IV PCA	72	180
other	vomiting	Gastrointestinal disorders	Sufentanil NanoTab PCA System/15 mcg	23	177
other	vomiting	Gastrointestinal disorders	Morphine IV PCA	20	180
other	constipation	Gastrointestinal disorders	Sufentanil NanoTab PCA System/15 mcg	20	177
other	constipation	Gastrointestinal disorders	Morphine IV PCA	15	180
other	dyspepsia	Gastrointestinal disorders	Sufentanil NanoTab PCA System/15 mcg	6	177
other	dyspepsia	Gastrointestinal disorders	Morphine IV PCA	2	180
other	oxygen saturation decreased	Investigations	Sufentanil NanoTab PCA System/15 mcg	17	177
other	oxygen saturation decreased	Investigations	Morphine IV PCA	17	180

1 to 10 of 96Source ClinicalTrials.gov

See all 96 adverse events

Adverse 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	Morphine IV PCA
Total, other adverse events	Sufentanil NanoTab PCA System/15 mcg	123	177
Total, other adverse events	Morphine IV PCA	122	180
Total, serious adverse events	Sufentanil NanoTab PCA System/15 mcg	6	177
Total, serious adverse events	Morphine IV PCA	7	180

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25155134	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 Morphine IV PCA: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01539538

GET https://conductscience.org/api/trials/v1/NCT01539538/events?page=2

API reference For AI assistants