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

Information source: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post Operative Pain

Intervention: Sufentanil NanoTab PCA System/15 mcg (Drug); Placebo Sufentanil NanoTab PCA System (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AcelRx Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Pamela Palmer, M.D., PhD, Study Director, Affiliation: Chief Medical Officer, AcelRx Pharmaceuticals, Inc.

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.

Clinical Details

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 for the Treatment of Post-Operative Pain in Patients After Knee or Hip Replacement Surgery

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

Primary outcome: Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID48).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Deidre Stonestreet, Damascus, Maryland, United States
Additional Information

Starting date: August 2012
Last updated: January 30, 2014

Page last updated: August 23, 2015

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