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CompletedNCT01539642Updated Oct 20, 2015Results posted

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

A Phase 3 interventional study of Sufentanil NanoTab PCA System/15 mcg and Placebo Sufentanil NanoTab PCA System in Post-Operative Pain, sponsored by Talphera, Inc. Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-20.

Sponsored by Talphera, Inc · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
172
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after open abdominal surgery.

02

Conditions studied

  • Post-Operative Pain

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Keywords

  • In patient, post operative pain
  • Adult post-operative inpatients who are expected to require parenteral opioid analgesia for at least 48 hours after open abdominal surgery
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 172 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Talphera, Inc is the lead sponsor of 18 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female patients who are 18 years or older
  • Patients who are scheduled to undergo an open abdominal surgery (including laparoscopic-assisted) under general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation.
  • Post-surgical patients who have been admitted to the PACU and are expected to remain hospitalized and to have acute post-operative pain requiring parenteral opioids for at least 48 hours after surgery.

Exclusion criteria

Exclusion Criteria:

  • 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 (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
  • Patients with an allergy or hypersensitivity to opioids.
  • Female patients who are pregnant or breast-feeding
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
172 participants (actual)

Study arms

  • Experimental
    Sufentanil NanoTab PCA System/15 mcg

    Drug: Sufentanil NanoTab PCA System/15 mcg

  • Placebo comparator
    Placebo Sufentanil NanoTab PCA System

    Drug: Placebo Sufentanil NanoTab PCA System

Interventions

  • DrugSufentanil NanoTab PCA System/15 mcg

    15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient may elect to remain in study for up to 72 hours.

    Also known as: sufentanil sublingual microtablet system, Zalviso™

  • DrugPlacebo Sufentanil NanoTab PCA System

    Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient may elect to remain in study for up to 72 hours.

06

What researchers measure

Primary outcomes

  1. Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48).

    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.

    Time frame: 48 hours

07

Results

Posted Feb 3, 2014

Participant flow

Recruitment period of 10 months - March 1, 2012 to December 28, 2012; Recruitment and screening occurred at clinical research centers and hospitals.

Participant flow — Overall Study
MilestoneSufentanil NanoTab PCA System/15 mcgPlacebo Sufentanil NanoTab PCA System
Started11458
Completed7827
Not completed3631
Withdrew: Lack of efficacy2018
Withdrew: Patient ready for early discharge87
Withdrew: Adverse event64
Withdrew: Withdrawal by subject22

Outcome measures

PrimaryTime-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48).

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.

Time frame:
48 hours
Reported as:
Least squares mean · Units on a scale
Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48).
Units on a scaleSufentanil NanoTab PCA System/15 mcgPlacebo Sufentanil NanoTab PCA System
Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48).105.60 ± 10.1455.58 ± 13.11
Statistical analysis
  • Sufentanil NanoTab PCA System/15 mcg vs Placebo Sufentanil NanoTab PCA System · ANCOVA · p = 0.001 · Mean difference (final values): 50.02 · 95% CI 19.89 to 80.14

Adverse events

Collected over Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sufentanil NanoTab PCA System/15 mcg—1/114 (0.9%)26/114 (22.8%)
Placebo Sufentanil NanoTab PCA System—0/58 (0%)15/58 (25.9%)
Most frequent serious events
Most frequent serious events
EventSufentanil NanoTab PCA System/15 mcgPlacebo Sufentanil NanoTab PCA System
Atrial FibrillationCardiac disorders1/1140/58
Most frequent other events
Showing 10 of 11
Most frequent other events
EventSufentanil NanoTab PCA System/15 mcgPlacebo Sufentanil NanoTab PCA System
NauseaGastrointestinal disorders16/11413/58
PruritusSkin and subcutaneous tissue disorders5/1140/58
Oxygen Saturation DecreasedInvestigations4/1141/58
VomitingGastrointestinal disorders4/1142/58
DizzinessNervous system disorders3/1141/58
AnxietyPsychiatric disorders2/1140/58
TachycardiaCardiac disorders2/1140/58
Abdominal PainGastrointestinal disorders0/1141/58
Chest PainGeneral disorders0/1141/58
HypertensionVascular disorders1/1141/58

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Sufentanil NanoTab PCA System/15 mcgPlacebo Sufentanil NanoTab PCA SystemTotal
<=18 years000
Between 18 and 65 years9136127
>=65 years232245
Age, Continuous
Age, Continuous(years)Sufentanil NanoTab PCA System/15 mcgPlacebo Sufentanil NanoTab PCA SystemTotal
Mean54.2 ± 13.557.4 ± 14.955.2 ± 14.0
Sex: Female, Male
Sex: Female, Male(Participants)Sufentanil NanoTab PCA System/15 mcgPlacebo Sufentanil NanoTab PCA SystemTotal
Female7949128
Male35944
Region of Enrollment
Region of Enrollment(participants)Sufentanil NanoTab PCA System/15 mcgPlacebo Sufentanil NanoTab PCA SystemTotal
United States11458172
08

Study locations

12 sites
  • Surgical Associates of Mobile
    Mobile, Alabama 36607, United States
  • Caring Clinical Research Corporation
    Laguna Hills, California 92653, United States
  • The Stamford Hospital
    Stamford, Connecticut 06904, United States
  • G&G Research
    Vero Beach, Florida 32960, United States
  • Rush Pain Center
    Chicago, Illinois 60612, United States
  • CRC of Jackson
    Jackson, Mississippi 39202, United States
  • Cooper University Hospital
    Camden, New Jersey 08103, United States
  • Phoenix OB GYN Associates
    Moorestown, New Jersey 08057, United States
  • New York Methodist Hospital
    Brooklyn, New York 11215, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Jefferson Hospital
    Philadelphia, Pennsylvania 19107, United States
  • Memorial Hermann -Memorial City Medical Center
    Houston, Texas 77024, United States
09

References and documents

Publications

  • Ringold FG, Minkowitz HS, Gan TJ, Aqua KA, Chiang YK, Evashenk MA, Palmer PP. Sufentanil sublingual tablet system for the management of postoperative pain following open abdominal surgery: a randomized, placebo-controlled study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):22-30. doi: 10.1097/AAP.0000000000000152. PubMed 25318408 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01539642
Lead sponsor
Talphera, Inc
Responsible party
Sponsor
First posted
Feb 27, 2012
Start date
Feb 2012
Primary completion
Jan 2013
Completion
Feb 2013
Results posted
Feb 3, 2014
Last update
Oct 20, 2015

Study contacts

Pamela Palmer, M.D., PhD
study director · Talphera, Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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