Clinical Study of KW-2246 in Patients With Cancer Pain - Full Text View

Sponsored by:	Kyowa Hakko Kogyo Co., Ltd.
Information provided by:	Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:	NCT00355628

Purpose

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

MedlinePlus related topics: Cancer

Drug Information available for: Fentanyl Citrate Fentanyl Oxycodone Oxycodone hydrochloride Citric acid Sodium Citrate

U.S. FDA Resources

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

Further study details as provided by Kyowa Hakko Kirin Pharma, Inc.:

Primary Outcome Measures:

Safety and Tolerability [ Time Frame: At every visit ] [ Designated as safety issue: Yes ]
Pain Intensity as Rated on a Categorical Scale [ Time Frame: At specified visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain Intensity as Rated on a Visual Analog Scale (VAS) [ Time Frame: At specified visits ] [ Designated as safety issue: No ]
Number of Rescue Doses per Day [ Time Frame: At every visit ] [ Designated as safety issue: No ]
Regular Dose Level of KW-2246 [ Time Frame: At every visit ] [ Designated as safety issue: No ]

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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provide written informed consent to participate in the study.
Be able to be hospitalized.
Between the ages of 20 and 80 years (inclusive) at the time of giving written informed consent.
Have regularly received oral morphine or oral oxycodone at an oral morphine equivalent dose of 20 to 120 mg/day for at least 2 days before study entry, AND not have required any rescue dose between regular doses.
Not have experienced intolerable toxicity for 2 days before study entry.
Have cancer that is in stable condition at study entry and expected to remain stable during the KW-2246 treatment period.
Have a life expectancy of at least 1 month after the start of KW-2246 administration.
Considered to be able to keep the patient diary.

Exclusion Criteria:

Serious respiratory dysfunction.
Asthma.
Serious bradyarrhythmia.
Serious hepatic or renal dysfunction.
Susceptibility to respiratory depression due to such conditions as increased intracranial pressure, head injury and brain tumor.
History of convulsive seizures (except a single episode of infantile febrile convulsions).
Current or past history of drug dependence or narcotic abuse.
Dry mouth that affects oral intake.
Use of opioid analgesics other than oral morphine or oxycodone within 7 days prior to study entry.
Use of narcotic antagonists within 7 days prior to study entry.
Interventions that may affect pain evaluation, such as surgery, radiation to the pain site (including those sites that influence pain) and nerve block, within 7 days prior to study entry or scheduled to be given during the study.
Patients with a history of serious adverse reactions to the combination of opioid analgesics and other drugs/substances who are currently receiving or expected to receive those drugs/substances combined to opioid analgesics.
History of hypersensitivity to fentanyl.
Pregnant or lactating women, possibly pregnant women or women who are planning to become pregnant.
Participation in any other clinical trial within 28 days prior to the start of KW-2246 treatment.
Prior exposure to KW-2246.
Patients whom an investigator judge unsuitable for enrollment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355628

Locations

Japan
Nagoya Medical Center
Nagoya, Japan

Sponsors and Collaborators

Kyowa Hakko Kogyo Co., Ltd.

Investigators

Study Director:

Masahiko Sato

Kyowa Hakko Kogyo Co., Ltd.

More Information

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

Keywords provided by Kyowa Hakko Kirin Pharma, Inc.:

Pain
Cancer
Neoplasm
Continual Reassessment Method
Pain Associated with Cancer/Neoplasms

Study placed in the following topic categories:

Morphine
Fentanyl
Citric Acid
Oxycodone
Pain

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 14, 2009