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NCT01539538 · ClinicalTrials.gov registry record · Phase 3

A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain

A Phase 3 study of Post Operative Pain, sponsored by Talphera.

Completed
Registry status
Phase 3
Development phase
357
Enrollment target
16
Study locations

NCT01539538 is a Phase 3 study of Post Operative Pain that has completed, run by Talphera. The registered enrollment target is 357 participants, above the 230-participant average among 56 other Post Operative Pain trials with a reported enrollment target (55% higher). The trial reports 16 study locations across 8 states.

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The verdict

NCT01539538, a Phase 3 study of Post Operative Pain, has completed, sponsored by Talphera.

COMPLETED
Registry status
Phase 3
Development phase
357 participants
Enrollment target
16
Study locations

Study Summary

The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.

Conditions Studied

Post Operative Pain

Interventions

  • DRUG Sufentanil NanoTab PCA System/15 mcg
  • DRUG morphine IV PCA

Study Locations (16)

Florida

  • Florida Research Associates, LLC - DeLand
  • River City Clinical Research - Jacksonville
  • Pensacola Research Consultants, Inc - Pensacola
  • Gulfcoast Research Institute - Sarasota
  • Phoenix Clinical Research LLC - Tamarac

Alabama

  • Eliza Coffee Memorial Hospital - Florence
  • Drug Research and Analysis Corp - Montgomery
  • Shoals Medical Trials, Inc - Sheffield

California

  • Lotus Clinical Research - Pasadena
  • Thorton Hospital - San Diego

Ohio

  • Cleveland Clinic Foundation - Cleveland
  • The Ohio State University - Columbus

Arizona

  • Arizona Research Center - Phoenix

Tennessee

  • Access Clinical Trials - Nashville

Texas

  • Endeavor Clinical Trials, PA - San Antonio

Utah

  • Jean Brown Research - Salt Lake City

Trial Details

FieldValue
Enrollment Target 357 participants
Start Date 2012-04
Est. Completion 2012-12
Phase Phase 3

Sponsor

Talphera

18 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01539538

The ClinicalTrials.gov registry entry for NCT01539538 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 357 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 230-participant average among 56 other Post Operative Pain trials with a reported enrollment target (55% higher). The listed sponsor is Talphera, which has 18 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Post Operative Pain appearing as the primary indexed condition, and to 2 interventions - of which Sufentanil NanoTab PCA System/15 mcg is the first listed.

NCT01539538 reports 16 study locations spanning 8 distinct geographic areas - top geographies include Florida, Alabama, California.

Frequently Asked Questions

What is clinical trial NCT01539538 about?

NCT01539538 is a clinical study titled "A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain". The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 ho...

What is the current status of trial NCT01539538?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 357 participants. The study started on 2012-04. Estimated completion is 2012-12.

What conditions does trial NCT01539538 study?

This clinical trial studies the following conditions: Post Operative Pain.

What interventions are being tested in trial NCT01539538?

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

Who is sponsoring clinical trial NCT01539538?

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

Where is trial NCT01539538 being conducted?

This trial has 16 study locations across Alabama, Arizona, California, Florida, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.