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Sponsored by: |
Nycomed |
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Information provided by: | Nycomed |
ClinicalTrials.gov Identifier: | NCT00496392 |
Primary:
• To compare the efficacy of nasal fentanyl (NF) to oral transmucosal fentanyl (Actiq®) (hereafter Actiq) in the management of breakthrough pain in cancer patients.
Secondary:
Condition | Intervention | Phase |
---|---|---|
Pain |
Drug: Nasal fentanyl |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | An Open Label, Comparative, Randomised, Balanced Crossover Trial Comparing Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq®) in Breakthrough Pain in Patients With Cancer |
Estimated Enrollment: | 115 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Responsible Party: | Nycomed ( Nycomed ) |
Study ID Numbers: | FT-019-IM, 2006-002087-26 |
Study First Received: | July 3, 2007 |
Last Updated: | July 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00496392 |
Health Authority: | France: Ministry of Health; Germany: Paul-Ehrlich-Institut; Italy: The Italian Medicines Agency; Spain: Spanish Agency of Medicines; United Kingdom: National Health Service |
breakthrough pain in patients with cancer |
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 |