A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain

Post-Operative Pain Clinical Trial

Official title:

A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539538
• Other study ID #: IAP309
• Status: Completed
• Phase: Phase 3
• First received: February 22, 2012
• Last updated: September 16, 2015
• Start date: April 2012
• Est. completion date: December 2012

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 study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• 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), total knee or total hip replacement surgery 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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, 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 q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
• morphine IV PCA
1 mg morphine administered IV q 6 minutes as needed for pain for at least 48 hours and up to 72 hours

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Florida Research Associates, LLC	DeLand	Florida
United States	Eliza Coffee Memorial Hospital	Florence	Alabama
United States	River City Clinical Research	Jacksonville	Florida
United States	Drug Research and Analysis Corp	Montgomery	Alabama
United States	Access Clinical Trials	Nashville	Tennessee
United States	Lotus Clinical Research	Pasadena	California
United States	Pensacola Research Consultants, Inc	Pensacola	Florida
United States	Arizona Research Center	Phoenix	Arizona
United States	Jean Brown Research	Salt Lake City	Utah
United States	Endeavor Clinical Trials, PA	San Antonio	Texas
United States	Thorton Hospital	San Diego	California
United States	Gulfcoast Research Institute	Sarasota	Florida
United States	Shoals Medical Trials, Inc	Sheffield	Alabama
United States	Phoenix Clinical Research LLC	Tamarac	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AcelRx Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Melson TI, Boyer DL, Minkowitz HS, Turan A, Chiang YK, Evashenk MA, Palmer PP. Sufentanil sublingual tablet system vs. intravenous patient-controlled analgesia with morphine for postoperative pain control: a randomized, active-comparator trial. Pain Pract. 2014 Nov;14(8):679-88. doi: 10.1111/papr.12238. Epub 2014 Aug 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Global Satisfaction	Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control	48 hours	No