At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 46 enrolled
Drug / intervention
Intranasal Fentanyl Spray (INFS) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Dose Titrated Clinical Trial With a Placebo-controlled, Double-blind, Randomised, Cross-over Phase to Demonstrate the Efficacy of 400 μg Intranasal Fentanyl (INFS) Dose Strength, and to Evaluate 12 Weeks Safety and Nasal Tolerability of All Dose Strengths Between 50 μg and 400 μg, in Cancer Patients With Breakthrough Pain.
In Brief
A Phase 3 clinical trial evaluating Intranasal Fentanyl Spray (INFS) and Placebo for Break Through Pain and Cancer. Completed, enrolled 46 participants across 11 sites in 3 countries.
Detailed Summary
The aim of this clinical trial was to demonstrate the efficacy of a 400 μg dose strength of intranasal fentanyl spray (INFS, Instanyl®) and to evaluate the safety and to establish long term tolerability of treatment with INFS doses of 50, 100, 200 and 400 μg.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreak Through Pain, Cancer
CountriesHungary, Norway, Russia
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2011
First PostedSep 2011
Primary CompletionJan 2013
TodayJul 2026
First PostedSep 5, 2011
Enrollment StartAug 1, 2011
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.8 years ago
Interventions
Intranasal Fentanyl Spray (INFS)drug
Applied as 1 puff (= 1 dose) in one nostril, or applied as two puffs (= 2 doses, 1 in each nostril) with ten minutes apart.
Placebodrug
Matching intranasal placebo spray