NCT00684632

Brief Summary

This study is designed to determine whether KW-2246 is superior to placebo and not inferior to immediate-release morphine for the relief of breakthrough pain in cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

20 active sites

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

March 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 26, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

August 28, 2020

Status Verified

August 1, 2020

Enrollment Period

1.1 years

First QC Date

May 22, 2008

Last Update Submit

August 27, 2020

Conditions

Pain, Cancer

Keywords

Pain, cancer

Study Arms (2)

1

EXPERIMENTAL

KW-2246

Drug: KW-2246 (fentanyl citrate)

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

PlaceboDRUG

Placebo

2
KW-2246 (fentanyl citrate)DRUG

KW-2246 (fentanyl citrate)

1

Eligibility Criteria

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

You may qualify if:

  • At the time of obtaining written informed consent
  • Provide written informed consent to participate in the study on a voluntary basis.
  • Between the ages of 20 and 80 years (inclusive).
  • Outpatients who live with a caregiver such as a family member, or inpatients.
  • Regularly receiving one of the following opioid analgesics: sustained-release oral morphine, sustained-release oral oxycodone, and fentanyl transdermal patch.
  • The daily dosage of the regular opioid analgesic regimen can be maintained constant from the baseline period through the end of the study as determined by the investigator.
  • 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.Be able to receive diary training and have the ability to properly complete diaries as determined by the investigator.
  • Have a life expectancy of at least three months as determined by the investigator.
  • Be able to receive diary training and have the ability to properly complete diaries as determined by the investigator.
  • At the time of randomization
  • The "regular opioid analgesic" being used at the time of giving written informed consent has been taken at a fixed dosage throughout the baseline period.
  • The "immediate-release morphine" being used at the time of giving written informed consent (Opso® (morphine hydrochloride hydrate) oral solution, morphine hydrochloride (powder), or morphine hydrochloride tablets) has been taken at a fixed dosage of 5, 10, 15, or 20 mg/dose throughout the baseline period.
  • Have received rescue medication at least 0.5 times but not more than three times per day on average during the baseline period.
  • Have had a pain intensity of at least 3 cm as rated on a visual analog scale (VAS) immediately before each of two or more rescue doses of immediate-release morphine during the baseline period, and had a mean decrease of at least 1.8 cm and at least one-third in VAS-rated pain intensity at 30 minutes after dosing compared with the pre-dose value.
  • +1 more criteria

You may not qualify if:

  • At the time of obtaining written informed consent
  • Intolerable adverse reactions (as defined in Attachment 3) to opioids.
  • 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.
  • Current or past history of drug dependence or narcotic abuse.
  • 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 giving written informed consent.
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Katori-shi, Chiba, Japan

Location

Unknown Facility

Matsuyama, Ehime, Japan

Location

Unknown Facility

Kitakyushu, Fukuoka, Japan

Location

Unknown Facility

Kōriyama, Fukushima, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Nishinomiya, Hyōgo, Japan

Location

Unknown Facility

Kasama, Ibaraki, Japan

Location

Unknown Facility

Kanazawa, Ishikawa-ken, Japan

Location

Unknown Facility

Uji, Kyoto, Japan

Location

Unknown Facility

Azumino, Nagano, Japan

Location

Unknown Facility

Ibaraki, Osaka, Japan

Location

Unknown Facility

Izumisano, Osaka, Japan

Location

Unknown Facility

Mibu, Tochigi, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, Japan

Location

Unknown Facility

Shinagawa-ku, Tokyo, Japan

Location

Unknown Facility

Kumamoto, Japan

Location

Unknown Facility

Okayama, Japan

Location

Unknown Facility

Toyama, Japan

Location

Unknown Facility

Wakayama, Japan

Location

Related Publications (1)

  • Shimoyama N, Gomyo I, Teramoto O, Kojima K, Higuchi H, Yukitoshi N, Ohta E, Shimoyama M. Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined from oral morphine rescue doses in the treatment of breakthrough cancer pain. Jpn J Clin Oncol. 2015 Feb;45(2):189-96. doi: 10.1093/jjco/hyu182. Epub 2014 Nov 6.

    PMID: 25378647DERIVED

MeSH Terms

Conditions

Cancer Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

PainNeurologic 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 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2008

First Posted

May 26, 2008

Study Start

March 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

August 28, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

JP(20)