Spots Global Cancer Trial Database for Efficacy and Safety of Intranasal Fentanyl in the Treatment of Breakthrough Pain (FT-018-IM)
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Trial Identification
Brief Title: Efficacy and Safety of Intranasal Fentanyl in the Treatment of Breakthrough Pain (FT-018-IM)
Official Title: A Double-blind, Randomised, Placebo-controlled Trial Confirming the Efficacy of Intranasal Fentanyl Titrated to 50, 100 or 200 µg With an Open Long-term Safety Follow-up in Cancer Patients With Breakthrough Pain
Study ID: NCT00362583
Conditions
Interventions
Study Description
Brief Summary: Primary objectives: * To confirm the efficacy of intranasal fentanyl titrated to doses 50, 100 or 200 µg for treatment of breakthrough pain (BTP) in cancer patients * To establish long-term safety of treatment with intranasal fentanyl Secondary objectives: - To explore the relationship between dose of background opioid treatment and titrated fentanyl dose
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Nycomed, Roskilde, , Denmark
Contact Details
Name: Nycomed Clinical Trial Operations
Affiliation: Headquaters
Role: STUDY_CHAIR
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