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Chronic PainPhase 3NCT01008618

A Confirmatory Study of Fentanyl in Participants With Osteoarthritis or Low Back Pain

A Phase 3 study testing Fentanyl in people with Chronic Pain and Osteoarthritis, run by Janssen Pharmaceutical K.K. at 59 sites 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 efficacy and safety of fentanyl in opioid-naive participants with osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stuff) or low back pain who cannot obtain a sufficient analgesic effect by the treatment of non-opioid… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Chronic Pain, Osteoarthritis, Low Back Pain
What is being tested?
Fentanyl
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
218 participants
Where
59 sitesJapan
Study dates
Jan 2009to Feb 2010
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 whose pain because of osteoarthritis or low back pain is continuing for at least 12 weeks prior to informed consent
  • Participants who are continuously taking a non-opioid analgesic at the normal highest dose or more for at least 14 consecutive days prior to informed consent, or participant at a certain dose (except the use on an as-needed base) on consecutive days
  • Participants showing insufficient therapeutic efficacy of the non-opioid analgesic currently being used, and requiring a continuous opioid analgesic as per the investigator or sub-investigator
  • Participants with an average pain intensity of 50 millimeter or more on the Visual Analog Scale (VAS) in 24-hour daily living prior to informed consent
  • Participants who can be hospitalized to the 4th day after the initiation of titration period

Who cannot join

  • In cases of low back pain, participants with severe pain of lower extremities due to radiculopathy (a problem in which one or more nerves are affected) than that of low back pain, or participants with disc herniation (a medical condition affecting the spine due to trauma, lifting injuries, or idiopathic [unknown] causes) requiring an operation
  • In cases of low back pain, participants with pain due to compression fracture
  • Participants who had an operation that may affect the assessment within 30 days before informed consent
  • Participants whose main cause of the pain to be assessed is considered attributable to psychogenic pain (physical pain that is caused, increased, or prolonged by mental, emotional, or behavioral factors)
  • Participants with asthma, bradyarrhythmia (slow irregular heart beat) and severe respiratory function disorders

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

Japan59 sites

  • Study site

    Aki

  • Study site

    Akō

  • Study site

    Amagasaki

  • Study site

    Anan

  • Study site

    Annaka

  • Study site

    Chiba

  • Study site

    Chiisagata

  • Study site

    Fuchū

  • Study site

    Fukuoka

  • Study site

    Fukuyama

  • Study site

    Hamamatsu

  • Study site

    Hiki

  • Study site

    Himeji

  • Study site

    Hiratsuka

  • Study site

    Hitachi-Naka

  • Study site

    Ichikawa

  • Study site

    Ikeda

  • Study site

    Ikoma

  • Study site

    Itō

  • Study site

    Izumo

  • Study site

    Kagoshima

  • Study site

    Kanazawa

  • Study site

    Kasama

  • Study site

    Kitakyushu

  • Study site

    Kochi

  • Study site

    Koga

  • Study site

    Komatsu

  • Study site

    Kure

  • Study site

    Kurume

  • Study site

    Kyoto

  • Study site

    Maebaru

  • Study site

    Matsudo

  • Study site

    Matsumoto

  • Study site

    Miyazaki

  • Study site

    Nagano

  • Study site

    Nagoya

  • Study site

    Niihama

  • Study site

    Ohkawa

  • Study site

    Ohmuta

  • Study site

    Ohta-Ku

  • Study site

    Ohtsu

  • Study site

    Ōita

  • Study site

    Osaka

  • Study site

    Otaru

  • Study site

    Saga

  • Study site

    Sagamihara

  • Study site

    Sapporo

  • Study site

    Sendai

  • Study site

    Suginami-Ku

  • Study site

    Takaoka

  • Study site

    Takasaki

  • Study site

    Takayama

  • Study site

    Tatebayashi

  • Study site

    Tokushima

  • Study site

    Tokyo

  • Study site

    Toshima-Ku

  • Study site

    Toyama

  • Study site

    Ube

  • Study site

    Yokohama

Other trials in Japan

About this study

Official title: A Verification Study of JNS020QD in Patients With Osteoarthritis or Low Back Pain

The purpose of this study is to evaluate efficacy and safety of fentanyl in opioid-naive participants with osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stuff) or low back pain who cannot obtain a sufficient analgesic effect by the treatment of non-opioid analgesics (drug used to control pain).

Read the detailed description

This is a multi-center (conducted in more than one center), double-blind (neither the participant nor the physician knows the assigned study drug), randomized (participants assigned study drug by chance), withdrawal study in opioid-naive participants with osteoarthritis or low back pain. The study will consist of titration period (10-29 days) and double-blind period (12 weeks) and the visits will include Day 5-7, 8, 15, 29 in titration period and Day 2-4, 8, 15, 22, 29, 43, 57, 71 and 85 in double-blind period. All the eligible participants will receive one-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) of either fentanyl at the dose ranging from 12.5 to 50 microgram per hour (mcg/hr) or matching placebo. Efficacy will be evaluated primarily by time to withdrawal due to insufficient analgesic efficacy. Participants' safety will be monitored throughout the study.

Being tested
Fentanyl, Placebo
Keywords
Chronic pain, Osteoarthritis, Low back pain, Fentanyl, JNS020QD, Patch, transdermal, Opioid analgesics
Medical subject headings
Chronic Pain, Osteoarthritis, Low Back Pain

What participants receive

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

  • FentanylDrug

    One-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm or thigh and replaced every day.

  • PlaceboDrug

    Placebo patch indistinguishable from one-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm or thigh and replaced every day.

Study groups in NCT01008618
Study groupRoleWhat they receive
Fentanyl (Titration period)ExperimentalOne-day adhesive transdermal patch containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which will be increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) score of the participants. The dose will be increased up to maximum of 50 mcg/hr. The treatment will be continued for 10-29 days and then the eligible participants from this group will be randomly assigned to either of the two groups in the double-blind period.
Receives: Drug: Fentanyl
Fentanyl (Double-blind period)ExperimentalParticipants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, will be administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which will be same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment will be continued for 12 weeks.
Receives: Drug: Fentanyl
Placebo (Double-blind period)Placebo comparatorParticipants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, will be administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) will be gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo will be gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment will continue for 12 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy

    Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted.

    Measured: Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)

Secondary outcomes (12)

  1. Pain Visual Analog Scale (VAS) Score - Titration Period

    The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a "100-millimeter (mm) VAS scale" by drawing a slash. The left margin (0 mm) was considered "No pain at all", and the right margin (100 mm) was considered "Severer pain than this is inconceivable". The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported.

    Measured: Day 12-14 (Screening period) and Day 27-29 (Titration period)

  2. Pain Visual Analog Scale (VAS) Score - Double-Blind Period

    The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a "100-millimeter (mm) VAS scale" by drawing a slash. The left margin (0 mm) was considered "No pain at all", and the right margin (100 mm) was considered "Severer pain than this is inconceivable". The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported.

    Measured: Day 27-29 (Titration period) and Day 83-85 (double-blind period)

  3. Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period

    The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: "Extremely satisfied", "Satisfied", "Neither satisfied nor dissatisfied", "Dissatisfied" and "Dissatisfied very much". The results were reported as Category 1 = At least "Neither satisfied nor dissatisfied", which included participants with general evaluation of "Extremely satisfied" to "Neither satisfied nor dissatisfied", and Category 2 = At least "Satisfied", which included participants with general evaluation of "Extremely satisfied" to "Satisfied".

    Measured: Day 1 and 29 or final evaluation (Titration period)

  4. Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period

    The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: "Extremely satisfied", "Satisfied", "Neither satisfied nor dissatisfied", "Dissatisfied" and "Dissatisfied very much". The results were reported as Category 1 = At least "Neither satisfied nor dissatisfied", which included participants with general evaluation of "Extremely satisfied" to "Neither satisfied nor dissatisfied", and Category 2 = At least "Satisfied", which included participants with general evaluation of "Extremely satisfied" to "Satisfied".

    Measured: Day 1 and 85 or final evaluation (double-blind period)

  5. Number of Doses of Rescue Treatment Per Day - Titration Period

    If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported.

    Measured: Day 1 and 29 or final evaluation (Titration period)

  6. Number of Doses of Rescue Treatment Per Day - Double-Blind Period

    If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported.

    Measured: Day 1 and 85 or final evaluation (double-blind period)

  7. Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period

    The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.

    Measured: Day 1 and 29 or final evaluation (Titration period)

  8. Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period

    The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.

    Measured: Day 1 and 85 or final evaluation (double-blind period)

  9. Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Titration Period

    The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.

    Measured: Day 1 and 29 or final evaluation (Titration period)

  10. Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Double-Blind Period:

    The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.

    Measured: Day 1 and 85 or final evaluation (double-blind period)

  11. Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period

    Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.

    Measured: Day 29 or final evaluation (Titration period)

  12. Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period

    Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.

    Measured: Day 1 and 85 or final evaluation (double-blind period)

Timeline

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

  1. First posted6 Nov 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01008618
Sponsor's protocol ID
CR015541
Other IDs
JNS020QD-JPN-N01
Status last verified
Nov 2013
First submitted
5 Nov 2009
Last updated
25 Dec 2013
Data monitoring committee
No

Publications

  • Arai T, Kashimoto Y, Ukyo Y, Tominaga Y, Imanaka K. Two placebo-controlled, randomized withdrawal studies to evaluate the fentanyl 1 day patch in opioid-naive patients with chronic pain. Curr Med Res Opin. 2015 Dec;31(12):2207-18. doi: 10.1185/03007995.2015.1092127. Epub 2015 Oct 19.

    PubMed 26359327

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fentanyl in people with Chronic Pain and Osteoarthritis, run by Janssen Pharmaceutical K.K. at 59 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 25 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 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?

Yes. Results are posted in the registry (first posted 10 Jul 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?

Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy (time frame: Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)). 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 NCT01008618, 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 25 Dec 2013.

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