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NeoplasmsPhase 3NCT01309386

A Safety and Efficacy Study of Oral Tapentadol Extended-Release in Japanese Participants

A Phase 3 study testing Tapentadol ER and Morphine SR in people with Neoplasms, run by Janssen Pharmaceutical K.K. at 22 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 the conversion rate based on the number of participants achieving pain control and safety within 1 week after switching the opioid (morphine-like medications) analgesics (drug used to control pain), when tapentadol extended-release (ER) (JNS024ER) is orally administered to… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Neoplasms
What is being tested?
Tapentadol ER and Morphine SR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
22 sitesJapan
Study dates
Aug 2010to Jan 2012
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 with documented clinical diagnosis (determination of the cause of a medical problem) of any type of cancer (abnormal tissue that grows and spreads in the body)
  • Participants with mean 24-hour Numerical Rating Scale (NRS) score (11-point NRS used to measure the pain level for the past 24-hours where 0=no pain to 10=pain as bad as you can imagine) during 3 days (Day -4 to Day -2) before randomization (study drug assigned by chance) less than 4.0
  • Women must be post-menopausal, surgically sterile, or before entry and throughout the study practicing an effective method of birth control
  • Participants using immediate-release (IR) morphine hydrochloride (HCl) or oxycodone HCl hydrate as rescue medication (rescue medications are medicines that may be administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) for breakthrough pain
  • Participants treated with around-the-clock opioid (morphine-like medications) therapy for moderate to severe (very serious, life threatening) chronic (lasting a long time), malignant (cancerous) tumor-related (a mass in a specific area) cancer (abnormal tissue that grows and spreads in the body) pain using one of the following opioid analgesics (drug used to control pain) before randomization: morphine SR tablet less than or equal to 120 milligram (mg) per day, oxycodone hydrochloride controlled release (CR) tablet: 15 mg to 80 mg per day, durotep MT (fentanyl transdermal [through the skin] matrix) patch less than or equal to 8.4 mg per patch, fentos tape less than or equal to 4 mg per tape, or oneduro patch less than or equal to 3.4 mg per patch

Who cannot join

  • Participants with complicated uncontrolled/clinically significant arrhythmia (uneven heart beat)
  • Participants who had received rescue doses 3 times or more daily within 3 days (Day -4 to Day -2) before the randomization
  • History of surgery intended for the cure of the primary disease or for the treatment of cancer pain within 28 days before screening
  • Participants who had application of radiotherapy (treatment of cancer using x-rays), nerve block, or stimulation analgesia within 7 days before screening
  • Participants with known allergies (over sensitivity to a substance), hypersensitivity, or intolerance to opioid analgesics or its excipients

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Japan22 sites

  • Study site

    Chiba

  • Study site

    Hamamatsu

  • Study site

    Ibaraki

  • Study site

    Kanagawa

  • Study site

    Katsushika-ku

  • Study site

    Kobe

  • Study site

    Kumamoto

  • Study site

    Matsumoto

  • Study site

    Matsuyama

  • Study site

    Nagasaki

  • Study site

    Nagoya

  • Study site

    Nishinomiya

  • Study site

    Ohmura

  • Study site

    Ohta

  • Study site

    Osaka

  • Study site

    Saga

  • Study site

    Sapporo

  • Study site

    Tokyo

  • Study site

    Toyama

  • Study site

    Toyohashi

  • Study site

    Utsunomiya

  • Study site

    Yokohama

Other trials in Japan

About this study

Official title: A Randomized, Open-Label, Parallel-Arm, Optimal Dose-Titration, Multicenter Study to Evaluate the Safety and Efficacy of Oral JNS024 Extended-Release (ER) in Japanese Subjects Treated With Around-the-Clock Opioid Analgesics for Their Moderate to Severe Chronic Malignant Tumor- Related Cancer Pain

The purpose of this study is to evaluate the conversion rate based on the number of participants achieving pain control and safety within 1 week after switching the opioid (morphine-like medications) analgesics (drug used to control pain), when tapentadol extended-release (ER) (JNS024ER) is orally administered to participants treated with around-the-clock opioid analgesics, for their moderate to severe (very serious, life threatening) chronic (lasting a long time) malignant (cancerous) tumor-related (a mass in a specific area) cancer (abnormal tissue that grows and spreads in the body) pain.

Read the detailed description

This is a randomized (study drug assigned by chance), open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), parallel-arm (participants receive 1 of 2 possible interventions during the same time frame throughout the study), optimal dose-titration, multicenter (when more than one hospital or medical school team work on a medical research study) study evaluating the conversion rate based on the number of participants achieving pain control and safety within 1 week after switching from an ongoing around-the-clock opioid analgesic (morphine sustained-release [SR], oxycodone controlled-release, or fentanyl transdermal) to tapentadol ER or morphine SR, for their moderate to severe chronic, malignant tumor-related cancer pain. The study consists of 2 periods: 1 to 2 week screening period, followed by 8-week open-label treatment period. During the study period, participants will be hospitalized or outpatient. However, it is preferable to be hospitalized 1 week before and 1 week after to evaluate efficacy before and after switching opioids for securing participants' safety. At Day 1, participants will receive either tapentadol ER or morphine SR twice daily. During the treatment period, the dose of the study drug will be titrated to the participant's optimal dose. The participants will receive either tapentadol ER or morphine SR twice daily for 8 weeks. The maximum dose allowed for tapentadol ER will be 500 milligram (mg) daily or morphine SR 140 mg daily throughout the study. Efficacy is primarily evaluated using pain intensity score on an 11 point Numerical Rating Scale (an 11-point NRS is used to measure the pain level where 0=no pain to 10=pain as bad as you can imagine). Participants' safety will also be monitored.

Conditions
Neoplasms
Being tested
Tapentadol ER, Morphine SR
Keywords
Tapentadol, Tumor related pain, Opioid, Cancer related pain, Morphine
Medical subject headings
Neoplasms, Cancer Pain

What participants receive

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

  • Tapentadol ERDrug

    Tapentadol ER 100 to 400 milligram (mg) orally daily for 8 weeks (maximum up to 500 mg daily), as per Investigator's discretion.

  • Morphine SRDrug

    Morphine SR 30 to 120 mg orally daily for 8 weeks (maximum up to 140 mg daily), as per Investigator's discretion.

Study groups in NCT01309386
Study groupRoleWhat they receive
Tapentadol ERExperimentalTapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator's discretion.
Receives: Drug: Tapentadol ER
Morphine SRActive comparatorMorphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator's discretion.
Receives: Drug: Morphine SR

What is being measured

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

  1. Percentage of Participants Who Achieved Pain Control

    Pain control was considered to be achieved for participants who met both of the following criteria for any consecutive 3 days during the first week of treatment period: a) Change from baseline of mean 24 hour numerical rating scale (NRS) (an 11-point NRS is used to measure the pain level where 0=no pain to 10=pain as bad as you can imagine) score less than +1.5, and b) when the frequency of rescue medication was twice or less per day.

    Measured: Week 1

Secondary outcomes (6)

  1. Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8

    Average pain intensity was assessed using an 11-point NRS to measure the pain level for the past 24-hours where 0=no pain to 10=pain as bad as you can imagine.

    Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8

  2. Number of Participants Who Discontinued Study Treatment Due to Lack of Efficacy

    Number of participants who discontinued the treatment due to lack of efficacy were assessed throughout the study.

    Measured: Baseline up to Week 8

  3. Number of Participants With Patient Global Impression of Change (PGIC)

    The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved".

    Measured: Week 1, 4 and 8

  4. Total Number of Days of Rescue Medication Over Time

    Total number of days of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication.

    Measured: Baseline up to Week 8

  5. Number of Doses of Rescue Medication Over Time

    Number of doses of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication.

    Measured: Baseline up to Week 8

  6. Average Change From Baseline in Amount of Rescue Medication Over Time

    Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication. Average amount was the averages of all doses recorded during the baseline period or during each week (Week 1, 2, 3, 4, 5, 6, 7 and 8).

    Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8

Timeline

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

  1. First posted7 Mar 2011 (estimated)
  2. Study startAug 2010
  3. Primary completionJan 2012
  4. Study completionJan 2012

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
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01309386
Sponsor's protocol ID
CR017326
Other IDs
JNS024ER-JPN-C03
Status last verified
Feb 2013
First submitted
17 Feb 2011
Last updated
13 Mar 2013
Data monitoring committee
No

Publications

  • Imanaka K, Tominaga Y, Etropolski M, Ohashi H, Hirose K, Matsumura T. Ready conversion of patients with well-controlled, moderate to severe, chronic malignant tumor-related pain on other opioids to tapentadol extended release. Clin Drug Investig. 2014 Jul;34(7):501-11. doi: 10.1007/s40261-014-0204-3.

    PubMed 24906437

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tapentadol ER and Morphine SR in people with Neoplasms, run by Janssen Pharmaceutical K.K. at 22 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 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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?

Yes. Results are posted in the registry (first posted 13 Mar 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 Who Achieved Pain Control (time frame: Week 1). 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 NCT01309386, 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 13 Mar 2013.

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