AzTrials
AzTrials

Pain, CancerPhase 3NCT00684632

A Phase III Clinical Study of KW-2246 for Breakthrough Pain in Cancer Patients

A Phase 3 study testing KW-2246 (fentanyl citrate) in people with Pain, Cancer, run by Kyowa Kirin Co., Ltd. at 20 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Pain, Cancer
What is being tested?
KW-2246 (fentanyl citrate)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
20 sitesJapan
Study dates
Mar 2008to Apr 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 16Show fewer
  • 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.
  • Have received diary training and been able to properly complete diaries during the baseline period.

Who cannot join

  • 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.
Show all 30Show fewer
  • 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.
  • Prior exposure to KW-2246.
  • Patients who are judged by the investigator/subinvestigator to be inappropriate for this study.
  • At the time of randomization
  • Have experienced intolerable adverse reactions (as defined in Attachment 3) to opioids during the baseline period.
  • Have received, during the baseline period, any morphine, oxycodone and fentanyl formulations other than the "regular opioid analgesic" being used at the time of giving written informed consent.
  • Use of codeine, dihydrocodeine, opium, pethidine, buprenorphine, pentazocine, tramadol, butorphanol, and eptazocine within seven days prior to randomization (except codeine at daily dosages up to 60 mg and dihydrocodeine at daily dosages up to 30 mg for the treatment of cough).
  • Interventions that may affect pain intensity rating, such as surgery, radiation therapy and nerve bThe daily dosages of systemically-acting adjuvant analgesics or drugs with analgesic activity have been modified during the baseline period.lock, within seven days prior to randomization.
  • Use of narcotic antagonists within seven days prior to randomization.
  • The daily dosages of systemically-acting adjuvant analgesics or drugs with analgesic activity have been modified during the baseline period.
  • The daily dosages of locally-acting adjuvant analgesics or drugs with analgesic activity being used for the relief of cancer pain have been modified during the baseline period.
  • The daily dosages of codeine (up to 60 mg/day) and dihydrocodeine (up to 30 mg/day) being used for the treatment of cough have been modified during the baseline period.
  • Have the following results in the most recent laboratory tests conducted within seven days prior to randomization:
  • AST >5 times the upper limit of normal at each study site (ULN); ALT >5 times ULN; or Serum creatinine >1.5 times ULN.
  • Dry mouth that affects sublingual administration (i.e., poor compliance during sublingual administration training with placebo).
  • Subjects who are judged by the investigator/subinvestigator to be inappropriate for the study.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Japan20 sites

  • Study site

    Azumino, Nagano

  • Study site

    Bunkyo-ku, Tokyo

  • Study site

    Ibaraki, Osaka

  • Study site

    Izumisano, Osaka

  • Study site

    Kanazawa, Ishikawa-ken

  • Study site

    Kasama, Ibaraki

  • Study site

    Katori-shi, Chiba

  • Study site

    Kitakyushu, Fukuoka

  • Study site

    Kōriyama, Fukushima

  • Study site

    Kumamoto

  • Study site

    Matsuyama, Ehime

  • Study site

    Mibu, Tochigi

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Nishinomiya, Hyōgo

  • Study site

    Okayama

  • Study site

    Sapporo, Hokkaido

  • Study site

    Shinagawa-ku, Tokyo

  • Study site

    Toyama

  • Study site

    Uji, Kyoto

  • Study site

    Wakayama

Other trials in Japan

About this study

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.

Conditions
Pain, Cancer
Being tested
Placebo, KW-2246 (fentanyl citrate)
Keywords
Pain, cancer
Medical subject headings
Cancer Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo

  • KW-2246 (fentanyl citrate)Drug

    KW-2246 (fentanyl citrate)

Study groups in NCT00684632
Study groupRoleWhat they receive
1ExperimentalKW-2246
Receives: Drug: KW-2246 (fentanyl citrate)
2Placebo comparatorPlacebo
Receives: Drug: Placebo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionApr 2009
  4. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00684632
Sponsor's protocol ID
2246-0702
Status last verified
Aug 2020
First submitted
22 May 2008
Last updated
28 Aug 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25378647

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KW-2246 (fentanyl citrate) in people with Pain, Cancer, run by Kyowa Kirin Co., Ltd. at 20 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00684632, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in