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

Journal of Supportive Oncology

Volumn 9, Issue 6, 2011, Pages 224-231

  Fallon, Marie ^{a,b,c,d,e,f,g}   Reale, Carlo ^{a,b,c,d,e,f,g}   Davies, Andrew ^{a,b,c,d,e,f,g}   Lux, A Eberhard ^{a,b,c,d,e,f,g}   Kumar, Kirushna ^{a,b,c,d,e,f,g}   Stachowiak, Andrzej ^{a,b,c,d,e,f,g}   Galvez, Rafael ^{a,b,c,d,e,f,g}  

^a UNIVERSITY OF EDINBURGH   (United Kingdom)

^b ROYAL SURREY COUNTY HOSPITAL   (United Kingdom)

^c SAPIENZA UNIVERSITY OF ROME   (Italy)

^d St Marien Hospital   (Germany)

^e Meenakshi Mission Hospital   (India)

^f Regionalny Zespo Opieki Paliatywnej Dom Sue Ryder   (Poland)

^g HOSPITAL UNIVERSITARIO VIRGEN DE LAS NIEVES   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

BUPRENORPHINE; FENTANYL; HYDROMORPHONE; MORPHINE SULFATE; NOSE SPRAY; OXYCODONE; PECTIN; PENTAZOCINE; PLACEBO;

ADULT; AGED; ANALGESIA; ARTICLE; ASTHENIA; CANCER PAIN; CLINICAL EVALUATION; COMPARATIVE EFFECTIVENESS; CONSTIPATION; CONTROLLED STUDY; CROSSOVER PROCEDURE; DEHYDRATION; DISEASE SEVERITY; DIZZINESS; DOSE TIME EFFECT RELATION; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG RELEASE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; SOMNOLENCE; TABLET; TREATMENT DURATION; VOMITING;

ADULT; AGED; ANALGESICS, OPIOID; BREAKTHROUGH PAIN; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; FENTANYL; HUMANS; MIDDLE AGED; MORPHINE; NASAL SPRAYS; NEOPLASMS; TABLETS;

EID: 82955196255     PISSN: 15446794     EISSN: 1879596X     Source Type: Journal    
DOI: 10.1016/j.suponc.2011.07.004     Document Type: Article

References (26)

1. Davies A.N., Dickman A., Reid C., et al. The management of cancer-related breakthrough pain: recommendations of a task group of the Science Committee of the Association for Palliative Medicine of Great Britain and Ireland. Eur J Pain 2009, 13:331-338.
2. Mercadante S., Radbruch L., Caraceni A., et al. Episodic (breakthrough) pain: consensus conference of an expert working group of the European Association for Palliative Care. Cancer 2002, 94:832-839.
3. Portenoy R.K., Hagen N.A. Breakthrough pain: definition, prevalence and characteristics. Pain 1990, 41:273-281.
4. Portenoy R., Bruns D., Shoemaker B., et al. Breakthrough pain in community-dwelling patients with cancer pain and noncancer pain, 1: prevalence and characteristics. J Opioid Manag 2010, 6:97-108.
5. Wiffen P.J. Evidence-based pain management and palliative care in issue one for 2008 of the Cochrane Library. J Pain Palliat Care Pharmacother 2008, 22:239-242.
6. Ruiz-Garcia V., Lopez-Briz E. Morphine remains gold standard in breakthrough cancer pain. BMJ 2008, 337:a3104.
7. Zeppetella G. Dynamics of breakthrough pain vs. pharmacokinetics of oral morphine: implications for management. Eur J Cancer Care (Engl) 2009, 18:331-337.
8. Zeppetella G. Opioids for cancer breakthrough pain: a pilot study reporting patient assessment of time to meaningful pain relief. J Pain Symptom Manage 2008, 35:563-567.
9. Collins S.L., Faura C.C., Moore R.A., et al. Peak plasma concentrations after oral morphine: a systematic review. J Pain Symptom Manage 1998, 16:388-402.
10. Davies A.N., Broadley K., Beighton D. Xerostomia in patients with advanced cancer. J Pain Symptom Manage 2001, 22:820-825.
11. Davies A.N., Vriens J. Oral transmucosal fentanyl citrate and xerostomia. J Pain Symptom Manage 2005, 30:496-497.
12. Jacobsen R., Moldrup C., Christrup L. Clinical rationale for administering fentanyl to cancer pain patients: two Delphi surveys of pain management experts in Denmark. J Opioid Manag 2008, 4:383-391.
13. Dale O., Hjortkjaer R., Kharasch E.D. Nasal administration of opioids for pain management in adults. Acta Anaesthesiol Scand 2002, 46:759-770.
14. Illum L. Nasal drug delivery-possibilities, problems and solutions. J Control Release 2003, 87:187-198.
15. Watts P., Smith A. PecSys: in situ gelling system for optimised nasal drug delivery. Expert Opin Drug Deliv 2009, 6:543-552.
16. Portenoy R., Burton A.W., Gabrail N., et al. A multicenter, placebo-controlled, double-blind, multiple-crossover study of fentanyl pectin nasal spray (FPNS) in the treatment of breakthrough cancer pain. Pain 2010, 151:617-624.
17. Hanks G.W., Conno F., Cherny N., et al. Morphine and alternative opioids in cancer pain: the EAPC recommendations. Br J Cancer 2001, 84:587-593.
18. Coluzzi P.H., Schwartzberg L., Conroy J.D., et al. Breakthrough cancer pain: a randomized trial comparing oral transmucosal fentanyl citrate (OTFC) and morphine sulfate immediate release (MSIR). Pain 2001, 91:123-130.
19. Farrar J.T., Berlin J.A., Strom B.L. Clinically important changes in acute pain outcome measures: a validation study. J Pain Symptom Manage 2003, 25:406-411.
20. Fisher A., Watling M., Smith A., et al. Pharmacokinetics and relative bioavailability of fentanyl pectin nasal spray 100-800 μg in healthy volunteers. Int J Clin Pharmacol Ther 2010, 48:860-867.
21. Watson A., El-Deredy W., Iannetti G.D., et al. Placebo conditioning and placebo analgesia modulate a common brain network during pain anticipation and perception. Pain 2009, 145:24-30.
22. Ploner M., Lee M.C., Wiech K., et al. Prestimulus functional connectivity determines pain perception in humans. Proc Natl Acad Sci USA 2010, 107:355-360.
23. Portenoy R.K., Payne D., Jacobsen P. Breakthrough pain: characteristics and impact in patients with cancer pain. Pain 1999, 81:129-134.
24. Portenoy R.K., Raffaeli W., Torres L.M., et al. Long-term safety, tolerability, and consistency of effect of fentanyl pectin nasal spray for breakthrough cancer pain in opioid-tolerant patients. J Opioid Manag 2010, 6:319-328.
25. Lemmens H.J., Wada D.R., Munera C., et al. Enriched analgesic efficacy studies: an assessment by clinical trial simulation. Contemp Clin Trials 2006, 27:165-173.
26. Straube S., Derry S., McQuay H.J., et al. Enriched enrollment: definition and effects of enrichment and dose in trials of pregabalin and gabapentin in neuropathic pain: a systematic review. Br J Clin Pharmacol 2008, 66:266-275.