Trial · NCT02356588
A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery
NCT02356588, Phase 3, Completed, Talphera, Inc; results first posted 2017-02-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery. Trials, record NCT02356588. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02356588
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery
- NCT number
- NCT02356588
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 161 participants, actual
- Lead sponsor
- Talphera, Inc
- Conditions
- Post-Operative Pain
- Interventions
- Sufentanil Tablet 30 mcg, Placebo Tablet
- First posted
- 2015-02-05
- Last updated
- 2017-02-13
- Results first posted
- 2017-02-13
Source ClinicalTrials.gov
Registered outcomes14
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 12-hour Study Period (SPID12). | 12 hours | The primary outcome measure is the summed pain intensity difference to baseline over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The observed SPID-12 scores ranged from -42.15 to 71.87 in the active group and -34.96 to 64.37 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity. |
| Secondary | Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24). | 24 hours | The primary outcome measure is the summed pain intensity difference to baseline over the 24-hour study period (SPID-24). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 24 hour study period. The SPID-24 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The observed SPID-24 scores ranged from -70.00 to 148.70 in the active group to -58.09 to 160.24 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity. |
| Secondary | TOTPAR12 | 12 hours | Total pain relief over the 12 hours. The observed total pain relief scores ranged from 4.08 to 47.50 in the active group and 1.77 to 33.71 in the placebo group. A higher score indicates greater pain relief. |
| Secondary | TOTPAR24 | 24 Hours | Total pain relief over the 24 hour study period. The observed total pain relief scores ranged from 12.35 to 95.23 in the active group and 2.61 to 82.04 in the placebo group. A higher score indicates greater pain relief. |
| Secondary | Time-weighted SPRID12 | 12 hours | Time-weighted summed pain relief intensity difference (SPRID) over the 12 hour study period. The observed SPRID scores ranged from -38.08 to 106.82 in the active group and -20.10 to 95.72 in the placebo group. A negative score indicates an increase in pain intensity and decrease in pain relief, while a higher score indicates a greater decrease in pain intensity and increase in pain relief. |
| Secondary | Time-weighted SPRID24 | 24 hours | Time-weighted summed pain relief intensity difference (SPRID) over the 24 hour study period. The observed SPRID scores ranged from -49.67 to 222.04 in the active group and -24.97 to 237.54 in the placebo group. A negative score indicates an increase in pain intensity and decrease in pain relief, while a higher score indicates a greater decrease in pain intensity and increase in pain relief. |
| Secondary | Patient Global Assessment | 24 hours | Proportion of patients who responded good or excellent to the global assessment of method of pain control at 24 hours |
| Secondary | Healthcare Professional Global Assessment | 24 hours | Proportion of Health Care Professionals who responded good or excellent to the global assessment of method of pain control at 24 hours |
| Secondary | Summed Pain Intensity Difference | 1 hour | The SPID-1 is calculated by summing the difference to baseline between baseline pain score and the pain score at each assessment time point through 1 hour. The observed SPID scores ranged from -2.00 to 5.25 in the active group to -4.90 to 3.00 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity. |
| Secondary | Analysis of Total Number of Doses Used During the 12-Hour Study Period in the ITT Population | Cumulative through 12 hours |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
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 12-hour Study Period (SPID12). | 12 hours | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24). | 24 hours | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | TOTPAR12 | 12 hours | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | TOTPAR24 | 24 Hours | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Time-weighted SPRID12 | 12 hours | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Time-weighted SPRID24 | 24 hours | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Patient Global Assessment | 24 hours | Percentage of patients | NUMBER | |
| SECONDARY | Healthcare Professional Global Assessment | 24 hours | Percentage of HCPs | NUMBER | |
| SECONDARY | Summed Pain Intensity Difference | 1 hour | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Analysis of Total Number of Doses Used During the 12-Hour Study Period in the ITT Population | Cumulative through 12 hours | mean number of tablets taken | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group28
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 12-hour Study Period (SPID12). | Sufentanil Tablet 30 mcg | 25.84 | Standard Error 1.71 | units on a scale | |
| Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12). | Placebo Tablet | 13.14 | Standard Error 2.35 | units on a scale | |
| Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24). | Sufentanil Tablet 30 mcg | 57.96 | Standard Error 3.45 | units on a scale | |
| Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24). | Placebo Tablet | 37.28 | Standard Error 4.75 | units on a scale | |
| TOTPAR12 | Sufentanil Tablet 30 mcg | 21.18 | Standard Error 0.87 | units on a scale | |
| TOTPAR12 | Placebo Tablet | 15.36 | Standard Error 1.19 | units on a scale | |
| TOTPAR24 | Sufentanil Tablet 30 mcg | 45.80 | Standard Error 1.81 | units on a scale | |
| TOTPAR24 | Placebo Tablet | 35.45 | Standard Error 2.49 | units on a scale | |
| Time-weighted SPRID12 | Sufentanil Tablet 30 mcg | 47.03 | Standard Error 2.35 | units on a scale | |
| Time-weighted SPRID12 | Placebo Tablet | 28.62 | Standard Error 3.24 | units on a scale |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sufentanil Tablet 30 mcg | 107 | |
| Overall Study | STARTED | Placebo Tablet | 54 | |
| Overall Study | COMPLETED | Sufentanil Tablet 30 mcg | 102 | |
| Overall Study | COMPLETED | Placebo Tablet | 41 | |
| Overall Study | NOT COMPLETED | Sufentanil Tablet 30 mcg | 5 | |
| Overall Study | NOT COMPLETED | Placebo Tablet | 13 |
Source ClinicalTrials.gov
Adverse events20
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 | Nausea | Gastrointestinal disorders | Sufentanil Tablet 30 mcg | 31 | 107 | |
| other | Nausea | Gastrointestinal disorders | Placebo Tablet | 12 | 54 | |
| other | Headache | Nervous system disorders | Sufentanil Tablet 30 mcg | 13 | 107 | |
| other | Headache | Nervous system disorders | Placebo Tablet | 6 | 54 | |
| other | Dizziness | Nervous system disorders | Sufentanil Tablet 30 mcg | 6 | 107 | |
| other | Dizziness | Nervous system disorders | Placebo Tablet | 2 | 54 | |
| other | Hypotension | Cardiac disorders | Sufentanil Tablet 30 mcg | 5 | 107 | |
| other | Hypotension | Cardiac disorders | Placebo Tablet | 2 | 54 | |
| other | Vomiting | Gastrointestinal disorders | Sufentanil Tablet 30 mcg | 6 | 107 | |
| other | Vomiting | Gastrointestinal disorders | Placebo Tablet | 1 | 54 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sufentanil Tablet 30 mcg | ||
| Total, all-cause mortality | Placebo Tablet | ||
| Total, other adverse events | Sufentanil Tablet 30 mcg | 49 | 107 |
| Total, other adverse events | Placebo Tablet | 21 | 54 |
| Total, serious adverse events | Sufentanil Tablet 30 mcg | 0 | 107 |
| Total, serious adverse events | Placebo Tablet | 2 | 54 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sufentanil Tablet 30 mcg vs Placebo Tablet: 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/NCT02356588
GET https://conductscience.org/api/trials/v1/NCT02356588/results?page=2