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

Completed · Phase 3 · Has a placebo group

Conditions studied: Post Operative Pain

In brief

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.

Key facts

Study ID

NCT01660763

Run by

Talphera, Inc

People needed

419

Starts

2012-08-01

Expected to finish

2013-05-01

Last updated by the study team

2015-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Deidre Stonestreet — Damascus, Maryland, United States

Full record on ClinicalTrials.gov

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