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NCT00859313 · ClinicalTrials.gov registry record · Phase 2

An Open-Label Functionality, Safety and Efficacy Study in Patients Undergoing Elective Unilateral Knee Replacement

A Phase 2 study, sponsored by Talphera.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target

NCT00859313 is a Phase 2 study that has completed, run by Talphera. The registered enrollment target is 30 participants.

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The verdict

NCT00859313, a Phase 2 study, has completed, sponsored by Talphera.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study Summary

This study is being performed to evaluate the functionality of a device (Sufentanil NanoTab® PCA System) that has been developed for use by patients to self-administer the ARX-F01 pain medication (Sufentanil NanoTab 15 mcg) for the treatment of post-operative pain after undergoing knee replacement surgery. Another goal of this study is to assess the safety and effectiveness of this non-invasive, sublingual route of administration of ARX-F01 in decreasing the amount of pain that a patient experiences following knee replacement surgery.

Interventions

  • DRUG Sufentanil NanoTab PCA System/15 mcg

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2009-04
Est. Completion 2009-08
Phase Phase 2

Sponsor

Talphera

18 total trials

What the Registry Record Tells You About NCT00859313

The ClinicalTrials.gov registry entry for NCT00859313 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 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 1 intervention - of which Sufentanil NanoTab PCA System/15 mcg is the first listed.

NCT00859313 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00859313 about?

NCT00859313 is a clinical study titled "An Open-Label Functionality, Safety and Efficacy Study in Patients Undergoing Elective Unilateral Knee Replacement". This study is being performed to evaluate the functionality of a device (Sufentanil NanoTab® PCA System) that has been developed for use by patients to self-administer the ARX-F01 pain medication (Sufentanil NanoTab 15 mcg) for the treatment of post-operative pain after undergoing knee replacement s...

What is the current status of trial NCT00859313?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2009-04. Estimated completion is 2009-08.

What interventions are being tested in trial NCT00859313?

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

Who is sponsoring clinical trial NCT00859313?

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.