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

Phase 3

Completed

• Conditions: Post Operative Pain
• Interventions: Drug: Placebo Sufentanil NanoTab PCA System; Drug: Sufentanil NanoTab PCA System/15 mcg

• Registration Number: NCT01660763
• Lead Sponsor: Talphera, Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-07
• Study First Submitted QC: 2012-08-07
• Study First Posted: 2012-08-09
• Primary Completion: 2013-04
• Study Completion: 2013-05
• Results First Submitted: 2013-10-24
• Results First Submitted QC: 2014-01-30
• Results First Posted: 2014-02-03
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-30
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 419

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Sufentanil NanoTab PCA System	Placebo Sufentanil NanoTab PCA System	-
Sufentanil NanoTab PCA System/15 mcg	Sufentanil NanoTab PCA System/15 mcg	-

Primary Outcome Measures

Name	Time	Method
Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID48).	48 hours	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

Trial Locations

Locations (1)

Deidre Stonestreet; 🇺🇸 Damascus, Maryland, United States