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Brief Title: A Clinical Trial With Intranasal Fentanyl in Cancer Patients With Breakthrough Pain
Official Title: 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.
Study ID: NCT01429051
Brief 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.
Detailed Description: This is a clinical trial with 12 weeks treatment of Intranasal fentanyl (INFS) in cancer patients with breakthrough pain (BTP). It was composed of a dose titrated, placebo-controlled, double-blind, randomised, cross-over efficacy phase, combined with a titration and a tolerability phase assessing the safety and nasal tolerability of INFS. The trial is set up with a screening period and three treatment phases: a titration phase (I), an efficacy phase (II) and a tolerability phase (III). The entire trial period for each completed patient consisted of the one week screening period and 12 weeks treatment with INFS.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Budapest, , Hungary
, Debrecen, , Hungary
, Kazincbarcika, , Hungary
, Nyíregyháza, , Hungary
, Pécs, , Hungary
, Drammen, , Norway
, Trondheim, , Norway
, Moscow, , Russian Federation
, Smolensk, , Russian Federation
, St. Petersburg, , Russian Federation
, Yaroslavl, , Russian Federation
Name: Medical Director, Clinical Science
Affiliation: Takeda
Role: STUDY_DIRECTOR