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Sponsored by: |
Kyowa Hakko Kogyo Co., Ltd. |
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Information provided by: | Kyowa Hakko Kirin Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00355628 |
This study is a Phase II open-label study to investigate the recommended conversion ratio (oral morphine dose to KW-2246) when switching oral morphine or oxycodone to KW-2246 in cancer patients.
Condition | Intervention | Phase |
---|---|---|
Pain Cancer |
Drug: KW-2246 (fentanyl citrate) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Clinical Study of KW-2246 in Patients With Cancer Pain - Maintenance Switch Study in Oral Morphine or Oral Oxycodone-Treated Patients |
Estimated Enrollment: | 40 |
Study Start Date: | July 2006 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
KW-2246 (fentanyl citrate)
|
Drug: KW-2246 (fentanyl citrate)
KW-2245
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This study is a Phase II open-label study to investigate, using the continual reassessment method procedure by pain intensity and safety as indicators, the recommended conversion ratio (oral morphine dose to KW-2246) when switching oral morphine or oxycodone to KW-2246 in cancer patients who have been maintained on oral morphine or oral oxycodone for pain and to evaluate the safety and efficacy of KW-2246.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Kyowa Hakko Kogyo, Ltd. ( Masahiko Sato, Study Director ) |
Study ID Numbers: | 2246-0401 |
Study First Received: | July 21, 2006 |
Last Updated: | February 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00355628 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Pain Cancer Neoplasm Continual Reassessment Method Pain Associated with Cancer/Neoplasms |
Morphine Fentanyl Citric Acid Oxycodone 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 |