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NCT01660763 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Talphera.

Completed
Registry status
Phase 3
Development phase
419
Enrollment target

NCT01660763 is a Phase 3 study that has completed, run by Talphera. The registered enrollment target is 419 participants.

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The verdict

NCT01660763, a Phase 3 study, has completed, sponsored by Talphera.

COMPLETED
Registry status
Phase 3
Development phase
419 participants
Enrollment target

Study 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.

Interventions

  • DRUG Sufentanil NanoTab PCA System/15 mcg
  • DRUG Placebo Sufentanil NanoTab PCA System

Trial Details

FieldValue
Enrollment Target 419 participants
Start Date 2012-08
Est. Completion 2013-05
Phase Phase 3

Sponsor

Talphera

18 total trials

What the Registry Record Tells You About NCT01660763

The ClinicalTrials.gov registry entry for NCT01660763 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 419 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Talphera, which has 18 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Sufentanil NanoTab PCA System/15 mcg is the first listed.

NCT01660763 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01660763 about?

NCT01660763 is a clinical study titled "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". 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.

What is the current status of trial NCT01660763?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 419 participants. The study started on 2012-08. Estimated completion is 2013-05.

What interventions are being tested in trial NCT01660763?

The interventions under investigation include: Sufentanil NanoTab PCA System/15 mcg (DRUG), Placebo Sufentanil NanoTab PCA System (DRUG).

Who is sponsoring clinical trial NCT01660763?

This trial is sponsored by Talphera, which has 18 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.