Original research
Efficacy and Safety of Fentanyl Pectin Nasal Spray Compared with Immediate-Release Morphine Sulfate Tablets in the Treatment of Breakthrough Cancer Pain: A Multicenter, Randomized, Controlled, Double-Blind, Double-Dummy Multiple-Crossover Study
Marie Fallon MB, ChB, MD, FRCP 
, 
, Carlo Reale MD, Andrew Davies MBBS, MSc, MD, FRCP, A. Eberhard Lux MD, Kirushna Kumar MBBS, MD, Andrzej Stachowiak MD, Rafael Galvez MD and Fentanyl Nasal Spray Study 044 Investigators Group
Received 10 February 2011; Accepted 18 July 2011. Available online 3 November 2011.
Background
Immediate-release morphine sulfate (IRMS) remains the standard treatment for breakthrough cancer pain (BTCP), but its onset of effect does not match the rapid onset and short duration of most BTCP episodes.
Objective
This study will evaluate the efficacy/tolerability of fentanyl pectin nasal spray (FPNS) compared with IRMS for BTCP.
Methods
Patients (n = 110) experiencing one to four BTCP episodes/day while taking ≥60 mg/day oral morphine (or equivalent) for background cancer pain entered a double-blind, double-dummy (DB/DD), multiple-crossover study. Patients completing a titration phase (n = 84) continued to a DB/DD phase: 10 episodes of BTCP were randomly treated with FPNS and oral capsule placebo (five episodes) or IRMS and nasal spray placebo (5 episodes). The primary end point was pain intensity (P < .05 FPNS vs. IRMS) difference from baseline at 15 minutes (PID15). Secondary end points were onset of pain intensity (PI) decrease (≥1-point) and time to clinically meaningful pain relief (CMPR, ≥2-point PI decrease). Safety and tolerability were evaluated by adverse events (AEs) and nasal assessments. By-patient and by-episode analyses were completed.
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