NCT00355628

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Last Updated

August 31, 2012

Status Verified

August 1, 2012

Enrollment Period

1 year

First QC Date

July 21, 2006

Last Update Submit

August 30, 2012

Conditions

PainCancer

Keywords

PainCancerNeoplasmContinual Reassessment MethodPain Associated with Cancer/Neoplasms

Outcome Measures

Primary Outcomes (2)

  • Safety and Tolerability

    At every visit

  • Pain Intensity as Rated on a Categorical Scale

    At specified visits

Secondary Outcomes (3)

  • 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

Study Arms (1)

1

EXPERIMENTAL

KW-2246 (fentanyl citrate)

Drug: KW-2246 (fentanyl citrate)

Interventions

KW-2246 (fentanyl citrate)DRUG

KW-2246

Also known as: Fentanyl citrate
1

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nagoya Medical Center

Nagoya, Japan

Location

MeSH Terms

Conditions

PainNeoplasms

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Study Director

    Kyowa Kirin Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2006

First Posted

July 24, 2006

Study Start

July 1, 2006

Primary Completion

July 1, 2007

Last Updated

August 31, 2012

Record last verified: 2012-08

Locations

JP(1)