Trials / Completed
CompletedNCT00833040
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 Multicenter, Randomized, Placebo-Controlled, Crossover Study for the Evaluation of the Safety, Tolerability, and Efficacy of ARX-F02 Compared to Placebo in the Treatment of Cancer Breakthrough Pain
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Talphera, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sublingual sufentanil NanoTabs™ and placebo NanoTabs™ | During the Titration Phase, patients titrated to the dose of sufentanil that provided adequate pain relief without intolerable side effects. Dosages were 20, 30, 40, 60 and 80 mcg. During the Double Blind Phase, patients were randomized to one of six sequences and took 7 doses of sufentanil (dosage determined in the titration phase, and 3 doses of placebo. |
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2010-03-01
- Completion
- 2010-03-01
- First posted
- 2009-01-30
- Last updated
- 2015-01-01
- Results posted
- 2015-01-01
Locations
13 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00833040. Inclusion in this directory is not an endorsement.