PMID- 22055892
OWN - NLM
STAT- MEDLINE
DCOM- 20120110
LR  - 20220318
IS  - 1544-6794 (Print)
IS  - 1544-6794 (Linking)
VI  - 9
IP  - 6
DP  - 2011 Nov-Dec
TI  - 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.
PG  - 224-31
LID - 10.1016/j.suponc.2011.07.004 [doi]
AB  - 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 (PID(15)). 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. RESULTS: Compared with IRMS, FPNS significantly improved mean 
      PID(15) scores. 57.5% of FPNS-treated episodes significantly demonstrated onset 
      of PI improvement by 5 minutes and 95.7% by 30 minutes. CMPR (>/= 2-point PI 
      decrease) was seen in 52.4% of episodes by 10 minutes. Only 4.7% of patients 
      withdrew from titration (2.4% in DB/DD phase) because of AEs; no significant 
      nasal effects were reported. CONCLUSION: FPNS was efficacious and well tolerated 
      in the treatment of BTCP and provided faster onset of analgesia and attainment of 
      CMPR than IRMS.
CI  - Copyright A(c) 2011. Published by Elsevier Inc.
FAU - Fallon, Marie
AU  - Fallon M
AD  - Edinburgh Cancer Research Centre, Western General Hospital, Crewe Road South, 
      Edinburgh, EH4 2XR, UK. Marie.Fallon@ed.ac.uk
FAU - Reale, Carlo
AU  - Reale C
FAU - Davies, Andrew
AU  - Davies A
FAU - Lux, A Eberhard
AU  - Lux AE
FAU - Kumar, Kirushna
AU  - Kumar K
FAU - Stachowiak, Andrzej
AU  - Stachowiak A
FAU - Galvez, Rafael
AU  - Galvez R
CN  - Fentanyl Nasal Spray Study 044 Investigators Group
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Support Oncol
JT  - The journal of supportive oncology
JID - 101181305
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Nasal Sprays)
RN  - 0 (Tablets)
RN  - 76I7G6D29C (Morphine)
RN  - UF599785JZ (Fentanyl)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Analgesics, Opioid/*therapeutic use
MH  - Breakthrough Pain/*drug therapy
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Fentanyl/administration & dosage/adverse effects/*therapeutic use
MH  - Humans
MH  - Middle Aged
MH  - Morphine/adverse effects/*therapeutic use
MH  - Nasal Sprays
MH  - Neoplasms/*physiopathology
MH  - Tablets
EDAT- 2011/11/08 06:00
MHDA- 2012/01/11 06:00
CRDT- 2011/11/08 06:00
PHST- 2011/02/10 00:00 [received]
PHST- 2011/07/08 00:00 [revised]
PHST- 2011/07/18 00:00 [accepted]
PHST- 2011/11/08 06:00 [entrez]
PHST- 2011/11/08 06:00 [pubmed]
PHST- 2012/01/11 06:00 [medline]
AID - S1544-6794(11)00181-9 [pii]
AID - 10.1016/j.suponc.2011.07.004 [doi]
PST - ppublish
SO  - J Support Oncol. 2011 Nov-Dec;9(6):224-31. doi: 10.1016/j.suponc.2011.07.004.