MedDataX Logo

Clinical Study of KW-2246 in Patients With Cancer Pain

NCT ID: NCT00355628

Last Updated: 2012-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

KW-2246 (fentanyl citrate)

Group Type EXPERIMENTAL

KW-2246 (fentanyl citrate)

Intervention Type DRUG

KW-2246

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

KW-2246 (fentanyl citrate)

KW-2246

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fentanyl citrate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Study Director

Role: STUDY_DIRECTOR

Kyowa Kirin Co., Ltd.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nagoya Medical Center

Nagoya, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2246-0401

Identifier Type: -

Identifier Source: org_study_id