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Clinical Study of KW-2246 in Patients With Cancer Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT00355628
First received: July 21, 2006
Last updated: August 30, 2012
Last verified: August 2012
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Company, Limited:

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
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
KW-2246 (fentanyl citrate)
Drug: KW-2246 (fentanyl citrate)
KW-2246
Other Name: Fentanyl citrate

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:

  1. Provide written informed consent to participate in the study.
  2. Be able to be hospitalized.
  3. Between the ages of 20 and 80 years (inclusive) at the time of giving written informed consent.
  4. 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.
  5. Not have experienced intolerable toxicity for 2 days before study entry.
  6. Have cancer that is in stable condition at study entry and expected to remain stable during the KW-2246 treatment period.
  7. Have a life expectancy of at least 1 month after the start of KW-2246 administration.
  8. Considered to be able to keep the patient diary.

Exclusion Criteria:

  1. Serious respiratory dysfunction.
  2. Asthma.
  3. Serious bradyarrhythmia.
  4. Serious hepatic or renal dysfunction.
  5. Susceptibility to respiratory depression due to such conditions as increased intracranial pressure, head injury and brain tumor.
  6. History of convulsive seizures (except a single episode of infantile febrile convulsions).
  7. Current or past history of drug dependence or narcotic abuse.
  8. Dry mouth that affects oral intake.
  9. Use of opioid analgesics other than oral morphine or oxycodone within 7 days prior to study entry.
  10. Use of narcotic antagonists within 7 days prior to study entry.
  11. 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.
  12. 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.
  13. History of hypersensitivity to fentanyl.
  14. Pregnant or lactating women, possibly pregnant women or women who are planning to become pregnant.
  15. Participation in any other clinical trial within 28 days prior to the start of KW-2246 treatment.
  16. Prior exposure to KW-2246.
  17. Patients whom an investigator judge unsuitable for enrollment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Nagoya Medical Center
Nagoya, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
Investigators
Study Director: Study Director Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT00355628     History of Changes
Other Study ID Numbers: 2246-0401
Study First Received: July 21, 2006
Last Updated: August 30, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyowa Hakko Kirin Company, Limited:
Pain
Cancer
Neoplasm
Continual Reassessment Method
Pain Associated with Cancer/Neoplasms

Additional relevant MeSH terms:
Citric Acid
Fentanyl
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anticoagulants
Central Nervous System Agents
Central Nervous System Depressants
Chelating Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sequestering Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014