John T Farrar1, John Messina, Fang Xie, Russell K Portenoy. 1. Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104-6021, USA. jfarrar@mail.med.upenn.edu
Abstract
OBJECTIVE: To evaluate the time of onset, overall efficacy, and safety of fentanyl buccal tablet (FBT) for noncancer-related breakthrough pain (BTP) in opioid-tolerant adults over 12 weeks. DESIGN: A novel 12-week study that mimicked clinical practice with dose titration to effective dose, open-label treatment, and three randomized, double-blind, placebo-controlled, multiple-crossover periods at weeks 4, 8, and 12. For each double-blind period, study patients received nine doses (FBT = 6, placebo = 3) in a randomized sequence. SETTING:Twenty-one study centers in the United States. POPULATION: Opioid-tolerantadults with noncancer-related chronic pain and BTP. OUTCOME MEASURES: The primary outcome was the sum of the pain intensity differences (PID) 5-60 minutes post dose (SPID₆₀) during the final double-blind period. Secondary outcomes included pain relief (PR), meaningful PR, and proportion of episodes with a PID of ≥33% and ≥50%. RESULTS: Of 148 patients who entered the titration phase, 105 (71%) achieved a successful dose and 81 (55%) participated in all three assessment periods in the study. The final RCT assessment period results demonstrated continued efficacy of FBT vs placebo (P < 0.05) for SPID₆₀ (mean [SD]: 7.7 [6.2] vs 4.6 [4.7]). The average onset of PR began at 5 minutes, with meaningful PR by ≤10 minutes. The proportion of episodes with ≥33% improvement in PI was 7% with FBT vs 3% with placebo at 5 minutes and with ≥50% was 17% vs 10% at 15 minutes. All periods showed similar results. Adverse events and patient discontinuations were generally typical of clinical opioid use. CONCLUSIONS:FBT showed continued clinically important analgesic effects and was generally well tolerated over 12 weeks of treatment. Wiley Periodicals, Inc.
RCT Entities:
OBJECTIVE: To evaluate the time of onset, overall efficacy, and safety of fentanyl buccal tablet (FBT) for noncancer-related breakthrough pain (BTP) in opioid-tolerant adults over 12 weeks. DESIGN: A novel 12-week study that mimicked clinical practice with dose titration to effective dose, open-label treatment, and three randomized, double-blind, placebo-controlled, multiple-crossover periods at weeks 4, 8, and 12. For each double-blind period, study patients received nine doses (FBT = 6, placebo = 3) in a randomized sequence. SETTING: Twenty-one study centers in the United States. POPULATION: Opioid-tolerant adults with noncancer-related chronic pain and BTP. OUTCOME MEASURES: The primary outcome was the sum of the pain intensity differences (PID) 5-60 minutes post dose (SPID₆₀) during the final double-blind period. Secondary outcomes included pain relief (PR), meaningful PR, and proportion of episodes with a PID of ≥33% and ≥50%. RESULTS: Of 148 patients who entered the titration phase, 105 (71%) achieved a successful dose and 81 (55%) participated in all three assessment periods in the study. The final RCT assessment period results demonstrated continued efficacy of FBT vs placebo (P < 0.05) for SPID₆₀ (mean [SD]: 7.7 [6.2] vs 4.6 [4.7]). The average onset of PR began at 5 minutes, with meaningful PR by ≤10 minutes. The proportion of episodes with ≥33% improvement in PI was 7% with FBT vs 3% with placebo at 5 minutes and with ≥50% was 17% vs 10% at 15 minutes. All periods showed similar results. Adverse events and patient discontinuations were generally typical of clinical opioid use. CONCLUSIONS:FBT showed continued clinically important analgesic effects and was generally well tolerated over 12 weeks of treatment. Wiley Periodicals, Inc.
Authors: Jordi Guitart; Isabel Vargas; Vicente De Sanctis; Julia Ferreras; Jose Fuentes; Rafael Salazar; Juan M Vázquez; Jordi Folch; Jordi Moya; Hermann Ribera; Francisco Rodelas; Albert Tomás; María Arilla; Joan Coma; Teresa Aberasturi; Dolores Sintes; Ester Lombán Journal: Clin Drug Investig Date: 2013-09 Impact factor: 2.859
Authors: Stefan Wirz; Michael Schenk; Hannes Hofbauer; Hans-Christian Wartenberg; Marco Cascella; Kristin Kieselbach Journal: Schmerz Date: 2020-09-25 Impact factor: 1.107