Clinical Study of KW-2246 in Patients With Cancer Pain
This study has been completed.
Sponsor:
Kyowa Hakko Kirin Company, Limited
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
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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:
- 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 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 Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Chelating Agents Molecular Mechanisms of Pharmacological Action Adjuvants, Anesthesia Central Nervous System Agents |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 16, 2013