Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00833040 · ClinicalTrials.gov registry record · Phase 2
A Study for the Evaluation of the Safety, Tolerability, and Efficacy of ARX-F02 (Sufentanil NanoTab) Compared to Placebo in the Treatment of Cancer Breakthrough Pain
A Phase 2 study, sponsored by Talphera.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT00833040: Completed Phase 2 study, sponsored by Talphera.
NCT00833040 is a Phase 2 study that has completed, run by Talphera. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00833040, a Phase 2 study, has completed, sponsored by Talphera.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of this research study was to evaluate ARX-F02 (Sufentanil NanoTab) versus placebo ("sugar" pill or inactive substance) in the management of breakthrough pain in cancer patients.
Primary Outcome
time-weighted SPID30 is the sum of the pain intensity difference (PID) over the 30 minute time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is recorded at pre-dose, 10, 15, 30, 45, and 60 minutes post-dose. The pain score at each assessment time through 30 minutes is subtracted from the baseline pain score to provide the total sum score or SPID30. A higher SPID30 is better and indicates a reduction in pain intensity compared to the baseline score.
Interventions
- DRUG Sublingual sufentanil NanoTabs™ and placebo NanoTabs™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2009-04 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
What the finished NCT00833040 record still lists
NCT00833040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which Sublingual sufentanil NanoTabs™ and placebo NanoTabs™ is the first listed.
NCT00833040 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00833040 about?
NCT00833040 is a clinical study titled "A Study for the Evaluation of the Safety, Tolerability, and Efficacy of ARX-F02 (Sufentanil NanoTab) Compared to Placebo in the Treatment of Cancer Breakthrough Pain". The purpose of this research study was to evaluate ARX-F02 (Sufentanil NanoTab) versus placebo ("sugar" pill or inactive substance) in the management of breakthrough pain in cancer patients.
What is the current status of trial NCT00833040?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2009-04. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00833040?
The interventions under investigation include: Sublingual sufentanil NanoTabs™ and placebo NanoTabs™ (DRUG).
Who is sponsoring clinical trial NCT00833040?
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 NCT00833040's enrollment target sits among peer trials
34 1539th of 2000 higher than 448 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02897063 · 34 participants · Phase 1
Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure
- NCT03906617 · 34 participants · Phase 4
Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine
- NCT03992378 · 34 participants · NA
Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis
- NCT04047849 · 34 participants · Phase 4
Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia