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PainPhase 3NCT00641667

An Efficacy and Safety Study of Fentanyl (JNS020QD) in Participants With Cancer Pain

A Phase 3 study testing Fentanyl in people with Pain and Cancer, run by Janssen Pharmaceutical K.K. at 1 site in Japan.

Completed

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

Official record
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Trial summary

The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants switched from morphine preparations, oral oxycodone preparations, fentanyl citrate injection or… 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteJapan
Study dates
Jan 2008to Jun 2008
Phase
Phase 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 receiving any of the following drugs at a stable dose for at least 3 days (or 9 days in case of fentanyl patch) before the start of application of the study drug: Morphine preparations at less than or equal to 314 milligram per day (mg/day) as an oral morphine equivalent dose of less than or equal to 157 mg/day for suppository or less than or equal to 104 mg/day for injection, oral oxycodone preparations at less than or equal to 209 mg/day, fentanyl citrate injection at less than or equal to 2.0 mg/day, fentanyl patch less than or equal to 7.5 mg
  • Participants assumed to use not more than 2 rescue doses (dose of a fast-acting opioid analgesic except fentanyl preparations used for lack of analgesic effect) daily for at least 3 days before the start of application of the study drug
  • Participants showing a pain intensity of less than or equal to 34 millimeter (mm) on a 100-mm visual analog scale (VAS)
  • Participants who have an established diagnosis of cancer and are notified of the disease
  • Participants who can be hospitalized during the course of application of the study drug

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 or 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
  • Participants with a history of hypersensitivity to fentanyl or other opioid analgesics

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Study site

    Kitakyushu

Other trials in Japan

About this study

Official title: A Phase III Study of JNS020QD in Cancer Pain Patients - Evaluation of the Efficacy and Safety of JNS020QD Switched From Opioid Analgesics

The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants switched from morphine preparations, oral oxycodone preparations, fentanyl citrate injection or fentanyl patch for cancer pain.

Read the detailed description

This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than one center) and non-comparative study of fentanyl one-day transdermal patch. The study consists of 3 periods: Pre-treatment observation period (4-7 days), Treatment period (10 days) and Follow-up period (2 days). Treatment will be initiated at 12.5 microgram per hour (mcg/hr) and the initial dose of fentanyl will be determined based on the daily dose of the opioid analgesic taken by the participant before entering the study and will be maintained for 2 days to ensure safety of participants. Dose escalation or reduction will be as per the Investigator's discretion from Day 3 to Day 7 and thereafter dose will be again maintained from Day 7 to Day 9, ranging from 12.5 mcg/hr-100 mcg/hr and the maximum application dose will be 300 mcg/hr. The patch will be applied on areas including the chest, abdomen, upper arm or thigh and will be replaced daily for 10 days (a total of 9 applications; including the day of final patch removal). Efficacy will primarily be evaluated by visual analog scale (VAS) score. Participants' safety will be monitored throughout the study.

Conditions
Pain, Cancer
Being tested
Fentanyl
Keywords
Pain, Cancer, Fentanyl, JNS020QD
Medical subject headings
Pain, Neoplasms

What participants receive

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

  • FentanylDrug

    Also called JNS020QD

    Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is as per Investigator's discretion (maximum applied dose is 300 mcg/hr) up to Day 7 and then dose is fixed for next 3 days that is Day 10 (end of treatment period).

Study groups in NCT00641667
Study groupRoleWhat they receive
FentanylExperimentalNot described
Receives: Drug: Fentanyl

What is being measured

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

  1. Percentage of Participants Achieving Pain Control

    Pain control was assessed based on change in Visual Analog Scale (VAS) and number of daily rescue doses during 3 days before completion of study drug from 3 days before start of study drug. For VAS score, a difference of less than or equal to +15 millimeter (mm) and for rescue doses, a difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS ranged from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting opioid analgesic (except fentanyl preparations) used for lack of analgesic effect.

    Measured: Day 10 or early discontinuation (ED)

Secondary outcomes (6)

  1. Number of Participants With Response Based on Patient's Global Assessment Scale

    Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug 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, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED

  2. Pain Intensity Visual Analog Scale (VAS) Score

    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 (pre-application), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED

  3. Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain

    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, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED

  4. Number of Participants With Total Duration of Pain Per Day

    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, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED

  5. Mean Number of Rescue Doses

    Rescue dose was defined as the dose of a fast-acting opioid analgesic (except fentanyl preparations) given in 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, Day 10 or ED

  6. Number of Participants With Response Based on Physician's Global Assessment Scale

    The treating physician assessed the therapeutic efficacy (effectiveness) of the study drug by 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 or ED

Timeline

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

  1. First posted24 Mar 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionJun 2008
  4. Study completionJun 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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00641667
Sponsor's protocol ID
CR014896
Other IDs
JNS020QD-JPN-C01
Status last verified
May 2013
First submitted
17 Mar 2008
Last updated
7 Jun 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fentanyl in people with Pain and Cancer, run by Janssen Pharmaceutical K.K. at 1 site 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 7 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 1 site 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 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?

Yes. Results are posted in the registry (first posted 8 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 Pain Control (time frame: Day 10 or early discontinuation (ED)). 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 NCT00641667.

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 7 Jun 2013.

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