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PainPhase 2/3NCT00644787

A Dose-Finding Study of Fentanyl (JNS020 QD) 1-Day Transdermal Patch in Participants With Cancer Pain

A Phase 2/3 study testing Fentanyl 1-day transdermal patch (Titration Phase), Fentanyl 1-day transdermal patch (Double Blind Phase) and Fentanyl 3-day transdermal patch (Double Blind Phase) in people with Pain and Cancer, run by Janssen Pharmaceutical K.K. at 43 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

The purpose of this study is to evaluate the efficacy and safety of fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that is put on the skin so the drug can enter the body through the skin) and to assess the non-inferiority of fentanyl 1-day application transdermal patch to fentanyl… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Pain, Cancer
What is being tested?
Fentanyl 1-day transdermal patch (Titration Phase), Fentanyl 1-day transdermal patch (Double Blind Phase) and Fentanyl 3-day transdermal patch (Double Blind Phase)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
156 participants
Where
43 sitesJapan
Study dates
Dec 2007to Oct 2008
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with cancer pain who were previously not treated with opioid analgesics (drug used to control pain)
  • Participants with a pain score of greater than or equal to 35 millimeter (mm) on a 100-mm visual analog scale (VAS)
  • Participants who are considered to have "insufficient response" to non-opioid analgesics and require treatment with opioid analgesics by the physician
  • Participants who have an established diagnosis of cancer and are notified of the disease
  • Participants who can be hospitalized during Period 1 (dose-titration period)

Who cannot join

  • Participants with impaired respiratory function due to chronic lung disease or others
  • Participants with asthma (breathing disorder in which there is wheezing and difficulty in breathing)
  • Participants with bradyarrhythmia (slow, irregular heartbeats)
  • Participants with following measurements indicative of hepatic or renal impairment during the pre-treatment observation period: Aspartate transaminase (AST) greater than 5 times the upper limit of reference range, Alanine transaminase (ALT) greater than 5 times the upper limit of reference range, serum creatinine greater than 3 times the upper limit of reference range
  • Participants with any cerebral damage, such as brain tumor, accompanied by increased intracranial pressure, disturbance of consciousness, coma, or respiratory disturbance

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

Japan43 sites

  • Study site

    Asahi

  • Study site

    Asahikawa

  • Study site

    Bunkyō City

  • Study site

    Chiba

  • Study site

    Chikushino-shi

  • Study site

    Fukuoka

  • Study site

    Fushimi

  • Study site

    Higashi-Ibaraki

  • Study site

    Himeji

  • Study site

    Hirosaki

  • Study site

    Hiroshima

  • Study site

    Hitachi

  • Study site

    Hohfu

  • Study site

    Ichinomiya

  • Study site

    Ikeda

  • Study site

    Iwakuni

  • Study site

    Kawachi-Nagano

  • Study site

    Kawasaki

  • Study site

    Kitakyushu

  • Study site

    Kiyose

  • Study site

    Kobe

  • Study site

    Kochi

  • Study site

    Matsue

  • Study site

    Matsuyama

  • Study site

    Nishinomiya

  • Study site

    Ōita

  • Study site

    Okayama

  • Study site

    Osaka

  • Study site

    Ōtake

  • Study site

    Sakai

  • Study site

    Sendai

  • Study site

    Shigenobu N/A

  • Study site

    Sonogishukugō

  • Study site

    Sunto

  • Study site

    Tamaho N/A

  • Study site

    Tokushima

  • Study site

    Tokyo

  • Study site

    Toyohashi

  • Study site

    Tsukuba

  • Study site

    Utsunomiya

  • Study site

    Wako

  • Study site

    Yamaguchi

  • Study site

    Yonago

Other trials in Japan

About this study

Official title: A Phase II/III Study of JNS020QD in Cancer Pain Patients - A Dose-Finding, Double-Blind Study of JNS020QD Compared With JNS005 in Patients Previously Untreated With Opioid Analgesics

The purpose of this study is to evaluate the efficacy and safety of fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that is put on the skin so the drug can enter the body through the skin) and to assess the non-inferiority of fentanyl 1-day application transdermal patch to fentanyl 3-day application (JNS005) transdermal patch in participants with cancer pain.

Read the detailed description

This is a multi-center (conducted in more than one center) study, consisting of two periods: Period 1 is open-label (all people know the identity of the intervention), non-comparative dose titration phase and Period 2 is double blind (neither physician nor participant knows the treatment that the participant receives), positive control (fentanyl 3-day application transdermal patch is used as control drug) phase. In Period 1, fentanyl 1-day application transdermal patch 12.5 microgram per hour (mcg/hr) will be applied to chest, abdomen, upper arm or thigh and will be maintained for 2 days to ensure the safety of participants. Dose escalation or reduction will be allowed based on participant's condition from Day 3 to Day 11 and thereafter dose will be maintained from Day 11 to Day 13 with a maximum application dose of 100 mcg/hr. The total duration of Period 1 is 14 days (a total of 13 applications; including the day of final patch removal). Participants who met the predefined criteria at the end of dose titration phase will enter the double blind phase. In double blind phase, participants will receive either fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application transdermal patch or fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch at the same dose as used at the completion of Period 1. The duration of Period 2 is 10 days. Efficacy will primarily be evaluated by percentage of participants achieving dose titration success and change in mean visual analog scale (VAS) score. Participants' safety will be monitored throughout the study.

Conditions
Pain, Cancer
Being tested
Fentanyl 1-day transdermal patch (Titration Phase), Fentanyl 1-day transdermal patch (Double Blind Phase), Fentanyl 3-day transdermal patch (Double Blind Phase), Placebo
Keywords
Pain, Cancer, Fentanyl, JNS020QD, JNS005
Medical subject headings
Pain, Neoplasms

What participants receive

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

  • Fentanyl 1-day transdermal patch (Titration Phase)Drug

    Also called JNS020QD

    Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end of treatment period, that is Day 14.

  • Fentanyl 1-day transdermal patch (Double Blind Phase)Drug

    Also called JNS020QD

    Fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

  • Fentanyl 3-day transdermal patch (Double Blind Phase)Drug

    Also called JNS005

    Fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

  • PlaceboDrug

    Placebo matching to fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase for 10 days.

  • PlaceboDrug

    Placebo matching to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase for 10 days.

Study groups in NCT00644787
Study groupRoleWhat they receive
Fentanyl 1-day transdermal patch (Titration Phase)ExperimentalFentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase enter the Double Blind Phase.
Receives: Drug: Fentanyl 1-day transdermal patch (Titration Phase)
Fentanyl 1-day transdermal patch (Double Blind Phase)ExperimentalParticipants who meet the predefined criteria at the end of Titration Phase and enter the Double Blind Phase receive fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
Receives: Drug: Fentanyl 1-day transdermal patch (Double Blind Phase); Drug: Placebo
Fentanyl 3-day transdermal patch (Double Blind Phase)Active comparatorParticipants who meet the predefined criteria at the end of Titration Phase and enter the Double Blind Phase receive fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
Receives: Drug: Fentanyl 3-day transdermal patch (Double Blind Phase); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Dose Titration Success

    Participants achieving dose titration success included all participants who had a mean Visual Analog Scale (VAS) score of less than or equal to 34 millimeter (mm) and received not more than 2 rescue doses during the last 3 days before the completion or discontinuation of dose titration phase. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain.

    Measured: Day 14 or early discontinuation (ED)

  2. Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase

    The mean VAS score for the last 3 days before the completion or discontinuation of Double Blind Phase was compared with that for the last 3 days before the completion or discontinuation of Dose Titration Phase and the change from Dose Titration Phase in the mean VAS Score at Double Blind Phase was reported. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable).

    Measured: Dose Titration Phase (Day 12 to Day 14) and Double Blind Phase (Day 8 to Day 10)

Secondary outcomes (13)

  1. Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase

    Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug to control pain on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied.

    Measured: Day 1 pre-application (PA), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED

  2. Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase

    Participants were asked to assess their satisfaction with respect to the therapeutic efficacy of the study drug to control pain on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied.

    Measured: Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED

  3. Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase

    Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as "no pain" and the right edge (100 mm) defined as "severest pain conceivable".

    Measured: Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED

  4. Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase

    Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as "no pain" and the right edge (100 mm) defined as "severest pain conceivable".

    Measured: Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED

  5. Percentage of Participants Achieving Pain Control in Double Blind Phase

    Pain control was assessed based on change in VAS and number of daily rescue doses during 3 days before completion of Double Blind Phase from 3 days before start of Double Blind Phase. For VAS score, difference of less than or equal to +15 mm and for rescue doses, difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS measured pain severity on a scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting oral morphine formulation used in case of breakthrough pain.

    Measured: Day 10 or ED

  6. Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase

    Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain.

    Measured: Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED

  7. Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase

    Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain.

    Measured: Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED

  8. Number of Participants With Total Duration of Pain Per Day in Titration Phase

    The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (<) 4 hours, 1 = greater than or equal to (>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day).

    Measured: Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED

  9. Number of Participants With Total Duration of Pain Per Day in Double Blind Phase

    The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (<) 4 hours, 1 = greater than or equal to (>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day).

    Measured: Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED

  10. Mean Number of Rescue Doses in Titration Phase

    Rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain or lack of analgesic effect.

    Measured: Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED

  11. Mean Number of Rescue Doses in Double Blind Phase

    Rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain or lack of analgesic effect.

    Measured: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED

  12. Number of Participants With Response Based on Physician's Global Assessment Scale in Titration Phase

    The treating physician assessed the therapeutic efficacy of the study drug to control pain on a 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.

    Measured: Day 14

  13. Number of Participants With Response Based on Physician's Global Assessment Scale in Double Blind Phase

    The treating physician assessed the therapeutic efficacy of the study drug to control pain on a 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.

    Measured: Day 10

Timeline

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

  1. First posted27 Mar 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionOct 2008
  4. Study completionOct 2008

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00644787
Sponsor's protocol ID
CR014899
Other IDs
JNS020QD-JPN-C02
Status last verified
Jun 2013
First submitted
24 Mar 2008
Last updated
13 Jun 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Fentanyl 1-day transdermal patch (Titration Phase), Fentanyl 1-day transdermal patch (Double Blind Phase) and Fentanyl 3-day transdermal patch (Double Blind Phase) in people with Pain and Cancer, run by Janssen Pharmaceutical K.K. at 43 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 5 inclusion and 5 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 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Yes. Results are posted in the registry (first posted 21 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Percentage of Participants Achieving Dose Titration Success (time frame: Day 14 or early discontinuation (ED)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00644787.

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 13 Jun 2013.

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