Trial · NCT02662764
Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg
NCT02662764, Phase 3, Completed, Talphera, Inc; results first posted 2018-08-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg. Trials, record NCT02662764. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02662764
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg
- NCT number
- NCT02662764
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 320 participants, actual
- Lead sponsor
- Talphera, Inc
- Conditions
- Moderate-to-severe Acute Pain
- Interventions
- Zalviso™ 15 mcg
- First posted
- 2016-01-26
- Last updated
- 2018-08-08
- Results first posted
- 2018-08-08
Source ClinicalTrials.gov
Registered outcomes56
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System | Up to 72 hours | |
| Primary | Percentage of Patients, if Any, With Tablets Dispensed But Not Requested | Up to 72 hours | |
| Primary | Percentage of Patients, if Any, With Tablet Dispensed When the Zalviso System Was in Lockout | Up to 72 hours | |
| Primary | Percentage of Patients With Misplaced Tablet(s) | Up to 72 hours | |
| Primary | Number of Misplaced Tablets (i.e., Tablet Found Outside the Patient's Mouth) | Up to 24 hours | |
| Primary | Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet (i.e., a Dispense Failure) | Up to 72 hours | |
| Primary | Number of Zalviso System Notifications to the Nurse to Retrain Patient to Not Pull Down on the Controller While Dosing | Up to 72 hours | |
| Primary | Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet That Caused an Analgesic Gap | Up to 72 hours | |
| Primary | Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 24 Hours as "Good" or "Excellent" | Up to 24 hours | |
| Primary | Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 48 Hours as "Good" or "Excellent" | Up to 48 hours |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 registered outcomesOutcomes57
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System | Up to 72 hours | percentage of patients | NUMBER | |
| PRIMARY | Percentage of Patients, if Any, With Tablets Dispensed But Not Requested | Up to 72 hours | percentage of patients | NUMBER | |
| PRIMARY | Percentage of Patients, if Any, With Tablet Dispensed When the Zalviso System Was in Lockout | Up to 72 hours | percentage of patients | NUMBER | |
| PRIMARY | Percentage of Patients With Misplaced Tablet(s) | Up to 72 hours | percentage of patients | NUMBER | |
| PRIMARY | Number of Misplaced Tablets (i.e., Tablet Found Outside the Patient's Mouth) | Up to 24 hours | tablets | NUMBER | |
| PRIMARY | Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet (i.e., a Dispense Failure) | Up to 72 hours | percentage of patients | NUMBER | |
| PRIMARY | Number of Zalviso System Notifications to the Nurse to Retrain Patient to Not Pull Down on the Controller While Dosing | Up to 72 hours | Notifications | NUMBER | |
| PRIMARY | Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System | Up to 72 hours | percentage of patients | NUMBER | |
| PRIMARY | Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet That Caused an Analgesic Gap | Up to 72 hours | percentage of participants | NUMBER | |
| PRIMARY | Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 24 Hours as Good or Excellent | Up to 24 hours | This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error. | percentage of patients | NUMBER |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 outcomesResults by group148
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System | Zalviso™ 15 mcg | 2.2 | percentage of patients | ||
| Percentage of Patients, if Any, With Tablets Dispensed But Not Requested | Zalviso™ 15 mcg | 0 | percentage of patients | ||
| Percentage of Patients, if Any, With Tablet Dispensed When the Zalviso System Was in Lockout | Zalviso™ 15 mcg | 0 | percentage of patients | ||
| Percentage of Patients With Misplaced Tablet(s) | Zalviso™ 15 mcg | 3.8 | percentage of patients | ||
| Number of Misplaced Tablets (i.e., Tablet Found Outside the Patient's Mouth) | Zalviso™ 15 mcg | 13 | tablets | ||
| Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet (i.e., a Dispense Failure) | Zalviso™ 15 mcg | 5.6 | percentage of patients | ||
| Number of Zalviso System Notifications to the Nurse to Retrain Patient to Not Pull Down on the Controller While Dosing | Zalviso™ 15 mcg | 0 | Notifications | ||
| Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System | Zalviso™ 15 mcg | 2.2 | percentage of patients | ||
| Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet That Caused an Analgesic Gap | Zalviso™ 15 mcg | 2.8 | percentage of participants | ||
| Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 24 Hours as Good or Excellent | Zalviso™ 15 mcg | 86.1 | percentage of patients |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zalviso™ 15 mcg | 320 | |
| Overall Study | COMPLETED | Zalviso™ 15 mcg | 290 | |
| Overall Study | NOT COMPLETED | Zalviso™ 15 mcg | 30 |
Source ClinicalTrials.gov
Adverse events22
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 | Bradycardia | Cardiac disorders | Zalviso™ 15 mcg | 17 | 320 | 34 |
| other | Tachycardia | Cardiac disorders | Zalviso™ 15 mcg | 8 | 320 | 8 |
| other | Nausea | Gastrointestinal disorders | Zalviso™ 15 mcg | 84 | 320 | 88 |
| other | Vomiting | Gastrointestinal disorders | Zalviso™ 15 mcg | 32 | 320 | 49 |
| other | Constipation | Gastrointestinal disorders | Zalviso™ 15 mcg | 8 | 320 | 8 |
| other | Oxygen saturation decreased | Investigations | Zalviso™ 15 mcg | 19 | 320 | 25 |
| other | Hypokalaemia | Metabolism and nutrition disorders | Zalviso™ 15 mcg | 14 | 320 | 14 |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Zalviso™ 15 mcg | 25 | 320 | 25 |
| other | Dizziness | Nervous system disorders | Zalviso™ 15 mcg | 14 | 320 | 16 |
| other | Headache | Nervous system disorders | Zalviso™ 15 mcg | 12 | 320 | 13 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zalviso™ 15 mcg | 0 | 320 |
| Total, other adverse events | Zalviso™ 15 mcg | 190 | 320 |
| Total, serious adverse events | Zalviso™ 15 mcg | 3 | 320 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02662764
GET https://conductscience.org/api/trials/v1/NCT02662764/registered?page=2