Novotna et al
1
conducted a randomized, open-labeled, placebo-controlled study in which sublingual
fentanyl citrate (fentanyl ethypharm; FE) was compared with placebo for breakthrough
pain. In this study, selected opioid-treated cancer patients with breakthrough pain
were treated with FE titrated to an effective dose using an open-labeled design. This
was followed by a double-blind phase in which FE was compared with placebo using a
crossover design in a selected group of patients. The same design was previously used
to study at least two other fentanyl citrate formulations.
2
,
3
- Kress H.G.
- Orońska A.
- Kaczmarek Z.
- et al.
Efficacy and tolerability of intranasal fentanyl spray 50 to 200 microg for breakthrough
pain in patients with cancer: a Phase III, multinational, randomized, double-blind,
placebo-controlled, crossover trial with a 10-month, open-label extension treatment
period.
Clin Ther. 2009; 6: 1177-1191
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References
- A randomized, placebo-controlled study of a new sublingual formulation of fentanyl citrate (fentanyl ethypharm) for breakthrough pain in opioid-treated patients with cancer.Clin Ther. 2014; 36: 357-367
- A multicenter, placebo-controlled, double-blind, multiple-cross-over study of fentanyl pectin nasal spray (FPNS) in the treatment of breakthrough cancer pain.Pain. 2010; 151: 617-624
- Efficacy and tolerability of intranasal fentanyl spray 50 to 200 microg for breakthrough pain in patients with cancer: a Phase III, multinational, randomized, double-blind, placebo-controlled, crossover trial with a 10-month, open-label extension treatment period.Clin Ther. 2009; 6: 1177-1191
- Efficacy and long-term tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain.Curr Med Res Opin. 2009; 25: 2877-2885
- Defining the clinically important difference in pain outcome measures.Pain. 2000; 88: 287-294
Article info
Publication history
Published online: July 18, 2014
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© 2014 Elsevier HS Journals, Inc. Published by Elsevier Inc. All rights reserved.
