Conditions: Cancer Pain
Keywords: Cancer breakthrough pain
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 34
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: During the Titration Phase, patients titrated to the effective dosage of sublingual sufentanil NanoTab™(20, 30, 40, 60 or 80 mcg). One sublingual sufentanil NanoTab™ was taken as needed for breakthrough pain.

During the Double-Blind Phase, patients were then randomized to one of six treatment sequences, each of which included seven active doses of sublingual sufentanil (dosage determined in Titration Phase) and three placebo doses taken in random order. One NanoTab™ was taken as needed for breakthrough pain.

Interventions: intervention 1: Sublingual sufentanil NanoTabs™ and placebo NanoTabs™
Intervention descriptions: intervention 1: 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.

Protocol document: