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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00683995
Other study ID # 2246-0703
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2008
Est. completion date October 2011

Study information

Verified date August 2020
Source Kyowa Kirin Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to assess the safety and efficacy of long-term KW-2246 treatment as rescue medication for breakthrough pain.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date October 2011
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Provide written informed consent to participate in the study on a voluntary basis.

- Patients who have been eligible for the confirmatory trial by meeting the inclusion criteria applicable at the time of giving written informed consent and those applicable at the time of randomization, and who have completed the confirmatory trial.

- Outpatients who live with a caregiver such as a family member, or inpatients.

- Require rescue medication at least 0.5 times (at least once every two days) but not more than three times per day on average as determined by the investigator.

- Performance Status (ECOG) of 3 or less at the time of giving written informed consent.

- Have a life expectancy of at least three months as determined by the investigator.

- Be able to receive diary training and have been able to properly complete diaries during the confirmatory trial.

Exclusion Criteria:

- Have experienced intolerable adverse reactions (as defined in Attachment 3) during the confirmatory trial.

- Have met any of the exclusion criteria applicable at the time of giving written informed consent, those applicable at the time of randomization, or subject withdrawal criteria in the confirmatory trial.

- Serious respiratory dysfunction.

- Asthma.

- Serious bradyarrhythmia.

- Serious hepatic dysfunction.

- Serious renal dysfunction.

- Susceptibility to respiratory depression due to conditions such as increased intracranial pressure, head injury and brain tumor.

- Patients who have a history of clinically significant adverse reactions to the combination of opioid analgesics and any of the following drugs/substances, and who are currently receiving or expect to receive any of them during the study:

Central nervous system depressants (phenothiazines, benzodiazepines and barbiturates), inhalation anesthetics, monoamine oxidase inhibitors, tricyclic antidepressants, skeletal muscle relaxants, antihistamines, ritonavir, alcohol, itraconazole, amiodarone, clarithromycin, diltiazem, and fluvoxamine.

- History of convulsive seizures (except a single episode of infantile febrile convulsions).

- History of hypersensitivity to fentanyl.

- Pregnant or lactating women, possibly pregnant women, or women who are planning to become pregnant.

- Patients who are judged by the investigator/subinvestigator to be inappropriate for this study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
KW-2246 (fentanyl citrate)
KW-2246 (fentanyl citrate)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

See also
  Status Clinical Trial Phase
Completed NCT03727373 - Qualitative Study for Pain Measurement Using Innovative Health Technology
Completed NCT00684632 - A Phase III Clinical Study of KW-2246 for Breakthrough Pain in Cancer Patients Phase 3
Completed NCT04176575 - Balancing Method for Pain Related to Advanced Cancer N/A