Chronic PainPhase 3NCT01493245

A Study of JNS020QD in Patients With Chronic Pain

A Phase 3 study testing JNS020QD in people with Chronic Pain, run by Janssen Pharmaceutical K.K. at 18 sites in Japan.

Completed

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

Trial summary

The purpose of this study is to evaluate the efficacy and safety of JNS020QD in patients with moderate to severe chronic pain who switched from opioid analgesics, as well as the safety and efficacy of long-term treatment (52 weeks) after switching to JNS020QD. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Chronic Pain
What is being tested?: JNS020QD
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 77 participants
Where: 18 sitesJapan
Study dates: Oct 2011to Mar 2013
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chronic pain that requires opioid analgesics and that has persisted for 12 weeks or longer before giving the consent
Patients who received any of the following opioid analgesics at a stable dose for the treatment of chronic pain for 7 days or longer before giving the consent (excluding rescue dose): oral codeine phosphate; oral morphine hydrochloride; fentanyl transdermal; combination tablet of tramadol hydrochloride and acetaminophen; buprenorphine transdermal patch
Patients who received 2 or less rescue doses per day during the 7 days before giving consent
Patients whose mean pain intensity throughout the day of giving the consent is 45 mm or less on the visual analogue scale (VAS)
Male and female patients surgically sterile, abstinent, or practicing an effective method of birth control. Female patients have a negative pregnancy test result at screening. Male patients cannot donate sperm during the study and for 3 months after receiving the last dose of study drug

Who cannot join

Other painful conditions which may interfere with the efficacy evaluation (eg bone fracture, rheumatoid arthritis)
Major surgery within 30 days before screening, or not fully recovered from surgery, or planned surgery during the time of the study
Pain that is considered mainly psychogenic
Uncontrolled/clinically significant arrhythmia
Hepatic function disorder such as fulminant hepatitis and hepatic cirrhosis, or renal impairment such as nephritic syndrome, acute or chronic renal failure
Any other condition that, in the opinion of the investigator, would compromise the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

Japan18 sites

Study site
Asahikawa
Study site
Chiba
Study site
Isesaki
Study site
Izumo
Study site
Kawasaki
Study site
Kobe
Study site
Matsumoto
Study site
Nishinomiya
Study site
Ohtsu
Study site
Okayama
Study site
Osaka
Study site
Saga
Study site
Sagamihara
Study site
Sapporo
Study site
Sendai
Study site
Toyama
Study site
Yamagata
Study site
Yamaguchi

Other trials in Japan

About this study

Official title: A Phase 3 Study of JNS020QD in Patients With Chronic Pain

Read the detailed description

The primary objective of this study is to evaluate the efficacy and safety of JNS020QD in patients with moderate to severe chronic pain who are switching from opioid analgesics. It will also evaluate the safety and efficacy of long-term treatment (52 weeks) after switching to JNS020QD. The study will enroll patients with moderate to severe chronic pain which is adequately controlled with a regular treatment with an opioid analgesic agent other than the study drug because these patients are considered appropriate to investigate the conversion ratio in switching from JNS020QD to other opioid analgesics, and to evaluate the efficacy and safety of the study drug. This is an open-label (all people know the identity of the intervention), uncontrolled (the study does not involve a control treatment), multicenter study. This study consists of Screening period (1 to 2 weeks), Period I (3-week titration period+ 1-week maintenance period), Period II (48 weeks long-term treatment period), tapering period (if required, 0 to 6 weeks), and follow-up period (1 week). JNS020QD is a transdermal system in which fentanyl base is incorporated directly into a single layer of pressure-sensitive high polymerized adhesive, and is changed once a day (every 24 hours). JNS020QD is available in 5 formulations containing fentanyl 0.84 mg, 1.7 mg, 3.4 mg, 5 mg, or 6.7 mg per system.. The study drug patch will be applied to the breast, abdomen, upper arm, femoral region, etc. exchanged daily and for consecutive 52 weeks.

Conditions: Chronic Pain
Being tested: JNS020QD
Keywords: Chronic Pain, JNS020QD, Fentanyl, Opioid analgesics
Medical subject headings: Chronic Pain

What participants receive

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

JNS020QDDrug
During weeks 1-3, initial doses of 0.84 mg, 1.7 mg, 3.4 mg, or 5 mg can be increased until individual optimal dose (up to maximum 20.1 mg) is determined. The optimal dose will be administered during the maintenance period (1 week), followed by a long-term treatment (48 weeks) period, where the dose will be adjusted (escalated or reduced) in consideration of the efficacy of the study, and the condition of adverse events. The patches are applied on the skin and exchanged daily (every 24 hours) for consecutive 52 weeks.

Study groups in NCT01493245
Study group	Role	What they receive
JNS020QD	Experimental	Not described Receives: Drug: JNS020QD

What is being measured

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

Proportion of patients who maintained the adequate analgesia
Criteria for maintenance of adequate analgesia is defined as: 1) The daily dose of the study drug is constant during the 7 days in the maintenance period before completion of the maintenance period; 2) Change in Visual Analogue Scale (VAS) mean values from baseline to endpoint is ≤+15 mm; 3) Frequency of daily rescue doses during the 7 days in the maintenance period is ≤ 2 doses, and the change in the mean frequency of daily rescue dose from the baseline to endpoint is ≤+1.0 dose.
Measured: At Week 4

Secondary outcomes (1)

Proportion of patients who achieve dose-adjustment
Criteria for achievement of dose-adjustment is defined as: 1) The daily dose of the study drug is constant during the 3 days before completion of the titration period; 2) Change in Visual Analogue Scale (VAS) mean values from baseline to endpoint is ≤+15 mm; 3) Frequency of daily rescue doses during the 3 days in the titration period is ≤2 doses; 4) daily doses of the study drug during the titration period does not exceed the maximum doses stipulated by the investigators.
Measured: Days 19-21

Timeline

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

Oct 2011Mar 2013

First posted15 Dec 2011 (estimated)
Study startOct 2011
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01493245
Sponsor's protocol ID: CR018745
Other IDs: JNS020QD-JPN-N04
Status last verified: Mar 2014
First submitted: 8 Dec 2011
Last updated: 24 Mar 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
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All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Study of JNS020QD in Patients With Chronic Pain
ClinicalTrials.gov ID: NCT01493245
Acronym / sponsor ID: CR018745
Conditions: Chronic Pain
Keywords: Chronic Pain, JNS020QD, Fentanyl, Opioid analgesics
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 15 Dec 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
JNS020QD	Experimental	Drug: JNS020QD

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Chronic pain that requires opioid analgesics and that has persisted for 12 weeks or longer before giving the consent
Patients who received any of the following opioid analgesics at a stable dose for the treatment of chronic pain for 7 days or longer before giving the consent (excluding rescue dose): oral codeine phosphate; oral morphine hydrochloride; fentanyl transdermal; combination tablet of tramadol hydrochloride and acetaminophen; buprenorphine transdermal patch
Patients who received 2 or less rescue doses per day during the 7 days before giving consent
Patients whose mean pain intensity throughout the day of giving the consent is 45 mm or less on the visual analogue scale (VAS)
Male and female patients surgically sterile, abstinent, or practicing an effective method of birth control. Female patients have a negative pregnancy test result at screening. Male patients cannot donate sperm during the study and for 3 months after receiving the last dose of study drug

Key exclusion criteria (6 listed)

Other painful conditions which may interfere with the efficacy evaluation (eg bone fracture, rheumatoid arthritis)
Major surgery within 30 days before screening, or not fully recovered from surgery, or planned surgery during the time of the study
Pain that is considered mainly psychogenic
Uncontrolled/clinically significant arrhythmia
Hepatic function disorder such as fulminant hepatitis and hepatic cirrhosis, or renal impairment such as nephritic syndrome, acute or chronic renal failure

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
JNS020QDDuring weeks 1-3, initial doses of 0.84 mg, 1.7 mg, 3.4 mg, or 5 mg can be increased until individual optimal dose (up to maximum 20.1 mg) is determined. The optimal dose will be administered during the maintenance period (1 week), followed by a long-term treatment (48 weeks) period, where the dose will be adjusted (escalated or reduced) in consideration of the efficacy of the study, and the condition of adverse events. The patches are applied on the skin and exchanged daily (every 24 hours) for consecutive 52 weeks.	Drug	JNS020QD

Primary outcome

Proportion of patients who maintained the adequate analgesia
Time frame: At Week 4
Criteria for maintenance of adequate analgesia is defined as: 1) The daily dose of the study drug is constant during the 7 days in the maintenance period before completion of the maintenance period; 2) Change in Visual Analogue Scale (VAS) mean values from baseline to endpoint is ≤+15 mm; 3) Frequency of daily rescue doses during the 7 days in the maintenance period is ≤ 2 doses, and the change in the mean frequency of daily rescue dose from the baseline to endpoint is ≤+1.0 dose.

1 secondary outcome

Proportion of patients who achieve dose-adjustment
Time frame: Days 19-21

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
A Phase 3 Study of JNS020QD in Patients with Chronic PainLink provided by the sponsor.

Related trials for Chronic Pain

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Pharmaceutical K.K., Japan Clinical Trial study director

Janssen Pharmaceutical K.K.

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JNS020QD in people with Chronic Pain, run by Janssen Pharmaceutical K.K. at 18 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 6 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 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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 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.

What does the primary outcome measure?

Proportion of patients who maintained the adequate analgesia (time frame: At Week 4). 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 NCT01493245.

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 24 Mar 2014.