Efficacy and Safety Trial to Evaluate the Sufentanil NanoTab® PCA System/15 mcg (Zalviso™) for Post-Operative Pain in Patients After Knee or Hip Replacement Surgery

Post Operative Pain Clinical Trial

Official title:

P3 - 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 Knee or Hip Replacement Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660763
• Other study ID #: IAP311
• Status: Completed
• Phase: Phase 3
• First received: August 7, 2012
• Last updated: September 30, 2015
• Start date: August 2012
• Est. completion date: May 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 total unilateral knee or total unilateral hip replacement surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients who are 18 years of age or older

• Patients who are scheduled for an elective cemented or uncemented total unilateral knee replacement or total unilateral hip replacement, under general or spinal anesthesia that does not include use of an intrathecal opioid

• 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 undergone a replacement of the same knee or hip

• 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

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 at least 48 hours. Patients 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 at least 48 hours. Patients may elect to remain in study for up to 72 hours.

Locations

Country	Name	City	State
United States	Deidre Stonestreet	Damascus	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
AcelRx Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Jove M, Griffin DW, Minkowitz HS, Ben-David B, Evashenk MA, Palmer PP. Sufentanil Sublingual Tablet System for the Management of Postoperative Pain after Knee or Hip Arthroplasty: A Randomized, Placebo-controlled Study. Anesthesiology. 2015 Aug;123(2):434-43. doi: 10.1097/ALN.0000000000000746. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID48).	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. Range of SPID48 scores were -239 to 417.; 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	48 hours	No