---
title: A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery
nct_id: NCT02356588
overall_status: COMPLETED
phase: PHASE3
sponsor: Talphera, Inc
study_type: INTERVENTIONAL
primary_condition: Post-Operative Pain
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02356588.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02356588"
ct_last_update_post_date: 2017-02-13
last_seen_at: "2026-05-12T06:15:07.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery

**Official Title:** A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for the Treatment of Post-Operative Pain in Patients After Abdominal Surgery

**NCT ID:** [NCT02356588](https://clinicaltrials.gov/study/NCT02356588)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 161
- **Lead Sponsor:** Talphera, Inc
- **Conditions:** Post-Operative Pain
- **Start Date:** 2015-02
- **Completion Date:** 2015-08
- **CT.gov Last Update:** 2017-02-13

## Brief Summary

The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of moderate-to-severe acute post-operative pain in patients after abdominal surgery.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria (additional criteria not specified here):

1. Patients who are scheduled to undergo one of the following procedures with general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation:

   * abdominoplasty
   * open tension-free inguinal hernioplasty (Lichenstein repair with mesh)
   * laparoscopic abdominal surgery
2. Patients classified as American Society of Anesthesiologists (ASA) class I - III (Appendix I).
3. Female patients of childbearing potential must be using an effective method of birth control at the time of screening visit
4. Patients who are expected to have moderate-to-severe post-operative pain for at least 24 hours.

Exclusion Criteria (additional criteria not specified here):

1. Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery
2. Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug.
3. Patients with current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure (CPAP).
4. Patients who previously have had abdominoplasty or have had an inguinal hernia repair on the same side.
```

## Arms

- **Sufentanil Tablet 30 mcg** (EXPERIMENTAL) — A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
- **Placebo Tablet** (PLACEBO_COMPARATOR) — A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.

## Interventions

- **Sufentanil Tablet 30 mcg** (DRUG)
- **Placebo Tablet** (DRUG)

## Primary Outcomes

- **Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).** _(time frame: 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 Outcomes

- **Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24).** _(time frame: 24 hours)_
- **TOTPAR12** _(time frame: 12 hours)_
- **TOTPAR24** _(time frame: 24 Hours)_
- **Time-weighted SPRID12** _(time frame: 12 hours)_
- **Time-weighted SPRID24** _(time frame: 24 hours)_
- **Patient Global Assessment** _(time frame: 24 hours)_
- **Healthcare Professional Global Assessment** _(time frame: 24 hours)_
- **Summed Pain Intensity Difference** _(time frame: 1 hour)_
- **Analysis of Total Number of Doses Used During the 12-Hour Study Period in the ITT Population** _(time frame: Cumulative through 12 hours)_
- **Analysis of Total Number of Doses Used During the 24-Hour Study Period in the ITT Population** _(time frame: 24 hours)_
- **Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population** _(time frame: Cumulative through 6 hours)_
- **Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population** _(time frame: Cumulative through 12 hours)_
- **Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population** _(time frame: Cumulative through 24 hours)_

## Locations (4)

- Shoals Medical Trials, Inc, Sheffield, Alabama, United States
- Lotus Clinical Research, Pasadena, California, United States
- Victory Medical Center, Houston, Texas, United States
- Research Concepts, LLC, Houston, Texas, United States

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.shoals medical trials, inc|sheffield|alabama|united states` — added _(2026-05-12)_
- `locations.lotus clinical research|pasadena|california|united states` — added _(2026-05-12)_
- `locations.victory medical center|houston|texas|united states` — added _(2026-05-12)_
- `locations.research concepts, llc|houston|texas|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02356588*  
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