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

NCT01660763 | Completed Phase 3 Results

• 1 other identifier: IAP311
• Study Type: interventional
• Target: 419
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Sufentanil NanoTab PCA System/15 mcg

EXPERIMENTAL

Drug: Sufentanil NanoTab PCA System/15 mcg

Placebo Sufentanil NanoTab PCA System

PLACEBO COMPARATOR

Drug: Placebo Sufentanil NanoTab PCA System

Interventions

Sufentanil NanoTab PCA System/15 mcg DRUG

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.

Also known as: sufentanil sublingual microtablet system, Zalviso™

Sufentanil NanoTab PCA System/15 mcg

Placebo Sufentanil NanoTab PCA System DRUG

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.

Placebo Sufentanil NanoTab PCA System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Talphera, Inc: lead

Study Sites (1)

Deidre Stonestreet

Damascus, Maryland, United States

Location

Related 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.

  PMID: 26079801 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sufentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pamela Palmer, MD, PhD
• Organization: AcelRx Pharmaceuticals, Inc

ppalmer@acelrx.com

650-216-3504

Study Officials

• Pamela Palmer, M.D., PhD

  Chief Medical Officer, AcelRx Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 9, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 20, 2015
• Results First Posted: February 3, 2014

Record last verified: 2015-09

Locations

US (1)