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

Post-Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539642
• Other study ID #: IAP310
• Status: Completed
• Phase: Phase 3
• First received: February 22, 2012
• Last updated: September 30, 2015
• Start date: February 2012
• Est. completion date: February 2013

Study information

• Verified date: September 2015
• Source: AcelRx Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-Operative Pain

Intervention

Drug:
• Sufentanil 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.
• Placebo 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.

Locations

Country	Name	City	State
United States	New York Methodist Hospital	Brooklyn	New York
United States	Cooper University Hospital	Camden	New Jersey
United States	Rush Pain Center	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	Memorial Hermann -Memorial City Medical Center	Houston	Texas
United States	CRC of Jackson	Jackson	Mississippi
United States	Caring Clinical Research Corporation	Laguna Hills	California
United States	Surgical Associates of Mobile	Mobile	Alabama
United States	Phoenix OB GYN Associates	Moorestown	New Jersey
United States	Jefferson Hospital	Philadelphia	Pennsylvania
United States	The Stamford Hospital	Stamford	Connecticut
United States	G&G Research	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AcelRx Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 hours	No