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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: Completed Phase 2 study, sponsored by Talphera.
NCT00859313 is a Phase 2 study that has completed, run by Talphera. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percent of patients who completed the study without a device failure. A device failure is defined as the failure to dispense a NanoTab, dispensing more than one NanoTab, or dispensing a broken NanoTab. Device failures were monitored and reported by study staff.
Interventions
- DRUG Sufentanil NanoTab PCA System/15 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2009-04 |
| Est. Completion | 2009-08 |
| Phase | Phase 2 |
What the finished NCT00859313 record still lists
NCT00859313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Sufentanil NanoTab PCA System/15 mcg is the first listed.
NCT00859313 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00859313's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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