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Sponsored by: |
Cephalon |
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Information provided by: | Cephalon |
ClinicalTrials.gov Identifier: | NCT00236145 |
The primary objective of the study is to determine whether a test titration regimen of ACTIQ treatment will reduce the number of inadequately managed episodes of breakthrough pain for an individual patient by attaining a successful dose of ACTIQ treatment more quickly. The successful ACTIQ dose provides a satisfactory combination of efficacy and tolerability after a single administration, as assessed by the patient.
Condition | Intervention | Phase |
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Breakthrough Pain |
Drug: ACTIQ (Oral transmucosal fentanyl citrate) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Open-Label, Parallel-Group Study to Evaluate the Efficacy and Safety of ACTIQ (Oral Transmucosal Fentanyl Citrate) Titrated According to 2 Regimens in Patients With Cancer and Breakthrough Pain |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: Patients are included in the study if all of the following criteria are met:
Exclusion Criteria: Patients are excluded from participating in this study if 1 or more of the following criteria are met:
France | |
Institut Gustave Roussy | |
Villejuif, France, 94800 | |
Centre Se Soins Palliatifs | |
Alix, France, 69380 | |
France, Cedex | |
Institut Claudius Regaud | |
Toulouse, Cedex, France, 31052 | |
Institut Oscar Lambret | |
Lille, Cedex, France, 59020 | |
Germany | |
University Clinics Aachen | |
Aachen, Germany, 52074 | |
University Clinics Aachen | |
Aachen, Germany, 52074 | |
University of Cologne | |
Cologne, Germany, 50931 | |
Knappschaftskrankenhaus Bottro | |
Bottrop, Germany, 46242 | |
United Kingdom | |
University of Sheffield | |
Sheffield, United Kingdom, S10 2JF | |
King Edward 7th Hospital | |
Midhurst, United Kingdom, GU29 0BL | |
St Bartholmew¿s Hospital | |
London, United Kingdom, EC1A 7BE | |
United Kingdom, Essex | |
St. Claires Hospice | |
Harlow, Essex, United Kingdom, CM17 9JX |
Study ID Numbers: | C8278A/302/ON/MN |
Study First Received: | October 7, 2005 |
Last Updated: | January 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00236145 |
Health Authority: | United States: Food and Drug Administration |
BTP Break through pain breakthrough pain |
Fentanyl Citric Acid 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 |