At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years with documented malignancy
- ✓Baseline opioid requirement of at least 60 mg/day oral morphine, 25 mcg/hr transdermal fentanyl, 30 mg/day oxycodone, or 8 mg/day oral hydromorphone for ≥1 week
- ✓Experiencing 1–4 episodes of cancer breakthrough pain per day on average, requiring rescue opioid analgesic
- ✓Life expectancy of at least 3 months
- ✕Uncontrollable or rapidly escalating pain
- ✕Psychiatric disease or cognitive impairment preventing reliable study documentation
- ✕Oral mucositis or stomatitis
- ✕History of substance abuse within the past year
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Sublingual sufentanil NanoTabs™ and placebo NanoTabs™ for Cancer and Pain. Completed, enrolled 34 participants across 13 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.