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Sponsored by: |
Nycomed |
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Information provided by: | Nycomed |
ClinicalTrials.gov Identifier: | NCT00345735 |
Primary Objective:
To demonstrate the efficacy of intranasal fentanyl in the treatment of breakthrough pain (BTP) in cancer patients.
Secondary Objective:
To explore the relationship between the response to the fentanyl dose and the stable background pain opioid dose.
Condition | Intervention | Phase |
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Cancer Pain |
Drug: Fentanyl |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Intranasal Fentanyl for the Treatment of Breakthrough Pain in Cancer Patients. A Randomised, Double-Blind, Placebo-Controlled, Cross-Over Confirmatory Trial Testing Fentanyl and Placebo in Eight Breakthrough Pain Episodes |
Estimated Enrollment: | 150 |
Study Start Date: | May 2006 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Has the patient had any recent therapy, which could potentially alter pain or response to analgesics to a degree, where the need for background pain opioid will be:
Responsible Party: | Clinical Trial Operations ( Nycomed ) |
Study ID Numbers: | FT-017-IM, 2005-002347-82 |
Study First Received: | June 26, 2006 |
Last Updated: | February 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00345735 |
Health Authority: | Austria: Federal Ministry for Health and Women; Denmark: Danish Medicines Agency; Germany: Paul-Ehrlich-Institut; Finland: National Agency for Medicines; France: Ministry of Health; Italy: National Institute of Health; Poland: Ministry of Health |
Cancer pain with breakthrough pain episodes |
Fentanyl Pain |
Anesthetics, Intravenous Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Narcotics Pharmacologic Actions Adjuvants, Anesthesia |
Sensory System Agents Anesthetics, General Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |