Clinical Study of KW-2246 in Patients With Cancer Pain

Phase II Clinical Study of KW-2246 in Patients With Cancer Pain - Maintenance Switch Study in Oral Morphine or Oral Oxycodone-treated Patients

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.

Study Overview

• Status: Completed
• Conditions: Pain; Cancer
• Intervention / Treatment: Drug: KW-2246 (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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Nagoya, Japan
    • Nagoya Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; KW-2246 (fentanyl citrate)	Drug: KW-2246 (fentanyl citrate); KW-2246; Other Names: Fentanyl citrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and Tolerability	At every visit
Pain Intensity as Rated on a Categorical Scale	At specified visits

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain Intensity as Rated on a Visual Analog Scale (VAS)	At specified visits
Number of Rescue Doses per Day	At every visit
Regular Dose Level of KW-2246	At every visit

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: July 21, 2006
• First Submitted That Met QC Criteria: July 21, 2006
• First Posted (Estimate): July 24, 2006

Study Record Updates

• Last Update Posted (Estimate): August 31, 2012
• Last Update Submitted That Met QC Criteria: August 30, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Cancer; Pain; Neoplasm; Continual Reassessment Method; Pain Associated with Cancer/Neoplasms
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anticoagulants; Chelating Agents; Sequestering Agents; Calcium Chelating Agents; Fentanyl; Citric Acid; Sodium Citrate
• Other Study ID Numbers: 2246-0401