PainPhase 2NCT00805142
Phase 2 Study of Tapentadol Prolonged Release in Cancer Pain Participants
A Phase 2 study testing Tapentadol PR in people with Pain and Cancer, run by Janssen Pharmaceutical K.K. at 21 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time; explores what the body does to the drug) of tapentadol prolonged release (JNS024PR, PR) in participants with moderate to… Read more about this study
- Who is it for?
- Ages 20 years and older
- What is being tested?
- Tapentadol PR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 21 sitesJapan
- Study dates
- Nov 2008to Jul 2009
- Phase
- Phase 2
- 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
- Opioid switching participants should meet the following criteria from a to c: a) Participants with cancer pain b) previously were on opioid medications (morphine sustained release preparations [120 milligram per day {mg/day} or less], oxycodone hydrochloride sustained release tablets [80 mg/day or less], fentanyl transdermal [through the skin] application system [4.2 mg or less]) c) had achieved adequate pain control with opioid therapy
- Opioid naive participants should meet the following criteria from a to b: a) Participants with cancer pain b) should not have received any pain control therapy with opioids (excluding narcotic antagonist analgesics [drug used to control pain])
- Definite diagnosis of any type of cancer, which has been notified to the participant
- Participants who can be hospitalized during the treatment period
- Participant who can record 11 point Numerical Rating Scale (NRS) and 100 millimeter (mm) Visual Analog Scale (VAS) scores appropriately throughout the study
Who cannot join
- Participants with bradyarrhythmia (slow, irregular heartbeats)
- History of mild or moderate traumatic (causing damage, like a toll used to crush tissue) encephalopathy, cerebral (having to do with the cerebrum) infarction (death of tissue because of lack of blood supply) or transient ischemic (decreased oxygen in a tissue [usually because of decreased blood flow]) attack within 1 year before informed consent
- Previous or concurrent epilepsy (seizure disorder) or convulsive diseases accompanied by disturbance of consciousness
- Previous or concurrent alcohol dependence or narcotic abuse
- History of active hepatitis (inflammation of the liver) B or C within 3 months before informed consent
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Japan21 sites
Study site
Chiba
Study site
Chikushino-shi
Study site
Fukuoka
Study site
Himeji
Study site
Hirosaki
Study site
Ichinomiya
Study site
Ikeda
Study site
Iwakuni
Study site
Kobe
Study site
Kochi
Study site
Kyoto
Study site
Nishinomiya
Study site
Ohta
Study site
Osaka
Study site
Sapporo
Study site
Sasebo
Study site
Shizuoka
Study site
Sonogishukugō
Study site
Tokyo
Study site
Toyonaka
Study site
Utsunomiya
About this study
Official title: Phase II Study of JNS024PR in Cancer Pain Patients
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time; explores what the body does to the drug) of tapentadol prolonged release (JNS024PR, PR) in participants with moderate to severe cancer (abnormal tissue that grows and spreads in the body until it kills) pain.
Read the detailed description
This is a Phase 2 open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), non-comparative, optional dose-titration study of tapentadol PR in Japanese participants with cancer pain. This study will consist of Screening period (3 to 7 days), Dose adjustment period (3 to 14 days), Fixed dose period (5 days) and Follow-up period (7 days). Tapentadol PR will be administered orally (taken by mouth; to be swallowed) twice daily before meal. For participants previously using opioids, the initial dose of tapentadol PR will be selected depending on the daily dose of opioid at the completion of Screening period. For opioid-naive (moderate to severe cancer pain that is not controlled adequately with non-opioid medications) participants, the initial dose of tapentadol PR will be 25 milligram (mg) twice daily. Participants will receive the same dose of tapentadol PR for the first 2 days of the dose adjustment period and from Day 3, the dose can be titrated as per the Investigator's discretion up to Day 14. After that participants will receive fixed dose regimen for 5 days at the same dose as that used at the end of the dose adjustment period. Efficacy will primarily be evaluated by sustained pain control for the 5 day fixed dose phase. Participants' safety will be monitored throughout the study.
- Being tested
- Tapentadol PR
- Keywords
- Pain, Cancer, Tapentadol
- Medical subject headings
- Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapentadol PRDrug
Also called Tapentadol hydrochloride, JNS024
Tapentadol PR tablets will be administered orally twice daily initiated at dose of 25 mg. Dose will be adjusted as per Investigator's discretion. Maximum dose limit is 500 mg per day. Total duration of treatment is 19 days.
| Study group | Role | What they receive |
|---|---|---|
| Opioid-Naive Participants (Tapentadol PR) | Experimental | Opioid-naive participants are defined as those who had moderate to severe cancer pain that is not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) is duration between start of treatment to day before initial dose in the maintenance period. Treatment will be initiated with tapentadol prolonged release (JNS024PR, PR) 25 milligram (mg) oral tablet twice daily. Dose will be increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit will be 500 mg per day. Participants will then be assigned to the treatment in the maintenance period (15-19 days). The maintenance period is duration between the first dose and the final assessment in the maintenance period. Participants will receive tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period. Receives: Drug: Tapentadol PR |
| Opioid-Switch Participants (Tapentadol PR) | Experimental | Opioid-switching participants are defined as those who had moderate to severe cancer pain that is controlled sufficiently with opioid therapy. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) is duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR is selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily is given depending on daily dose of opioid at completion of Screening period. Maximum dose limit is 500 mg per day. Participants will then be assigned to treatment in maintenance period (15-19 days). Maintenance period is defined as duration between first dose and final assessment in maintenance period. Participants will receive tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period. Receives: Drug: Tapentadol PR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase
Percentage of participants with sustained pain control for 5 day fixed dose phase were the participants who completed 5 day maintenance period, whose mean Numerical Rating Scale (NRS) score during the fixed dose phase and which was assessed immediately before giving each dose was less than 4 and the number of rescue doses per day for fixed dose phase was 2 or less. Pain intensity scores were recorded 0 to 30 minutes before dose on 11 point NRS where 0 = no pain and 10 = severest pain imaginable.
Measured: Day 15 up to Day 19
Secondary outcomes (9)
Percentage of Participants Who Achieve Dose Adjustment
Percentage of participants who achieved dose adjustment included those participants whose dose was adjusted during the titration period period and entered the fixed dose maintenance period. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period.
Measured: Day 3 up to Day 14
Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale
Pain intensity scores were measured on 11 point NRS, where 0 = no pain and 10 = severest pain imaginable. The pain intensity at Baseline was the average of scores on two consecutive morning doses (Day -1 and Day 0) and on Day 20 only a single observation was recorded.
Measured: Baseline (Average of Day -1 and Day 0 morning scores), Day 20
Pain Assessment Using Visual Analog Scale (VAS) Score
Pain VAS assesses the pain intensity experienced by the participant on a 100 millimeter (mm) VAS, where responses range from a response of no pain (score of 0 mm) to severest pain imaginable (score of 100 mm). The participant indicated the pain by marking the applicable place with slash (/) and the investigator then measured the length from left edge to the slash.
Measured: Baseline and Day 19
Rescue Doses
The immediate release (IR) oral opioids were used as rescue doses in the participants with lack of efficacy or to have relief from severe pain. In case of opioid-switching participants rescue doses were continued without any change in the preceding doses or the type throughout the study. The IR morphine HCl was used as the rescue dose for opioid-naive participants. The upper limit of rescue doses was specified for each daily dose of tapentadol PR. There was no change in the dose of rescue medication during maintenance period for opioid-naive participants.
Measured: Day 12, 13, 14, 15, 16, 17, 18 and 19
Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy
The AE is an undesirable or unwanted consequence that occurred during the course of the clinical trial, but not necessarily because of study drug.The AEs included the onset of new symptoms, worsening of the frequency or severity of the symptom compared with Baseline, and abnormal findings including abnormal laboratory test values in the diagnostic examination. The participants who discontinued because of lack of efficacy were those in which satisfactory analgesia was not maintained.
Measured: Baseline up to 7 days after last dose of study treatment
Sleep Questionnaire Regarding Time to Sleep and Total Time Slept
The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night. The participants were asked about the time taken by them to fall asleep previous night after bedtime and the total time they slept during previous night.
Measured: Pre-dose (Day 1) and Day 20
Sleep Questionnaire Regarding Number of Awakenings
The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night . Participants were asked to provide the number of times they awoke at night.
Measured: Pre-dose (Day 1) and Day 20
Sleep Questionnaire Regarding the Quality of Sleep
The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night. Participants rated overall sleep quality on a scale ranging from excellent to very poor.
Measured: Pre-dose (Day 1) and Day 20
Patient's Global Impression of Change (PGI-C)
PGI-C is a participant rated instrument to measure participant's change in overall status of general condition including pain on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).
Measured: Day 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Grünenthal GmbH
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutical K.K., Japan Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805142
- Sponsor's protocol ID
- CR015532
- Other IDs
- JNS024PR-JPN-C01
- Status last verified
- Jun 2013
- First submitted
- 8 Dec 2008
- Last updated
- 29 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of JNS024PR in Cancer Pain Patients
- ClinicalTrials.gov ID
- NCT00805142
- Acronym / sponsor ID
- CR015532
- Keywords
- Pain, Cancer, Tapentadol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Collaborators
- Grünenthal GmbH
- Study start
- Nov 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Posted 29 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time; explores what the body does to the drug) of tapentadol prolonged release (JNS024PR, PR) in participants with moderate to severe cancer (abnormal tissue that grows and spreads in the body until it kills) pain.
Detailed description
This is a Phase 2 open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), non-comparative, optional dose-titration study of tapentadol PR in Japanese participants with cancer pain. This study will consist of Screening period (3 to 7 days), Dose adjustment period (3 to 14 days), Fixed dose period (5 days) and Follow-up period (7 days). Tapentadol PR will be administered orally (taken by mouth; to be swallowed) twice daily before meal. For participants previously using opioids, the initial dose of tapentadol PR will be selected depending on the daily dose of opioid at the completion of Screening period. For opioid-naive (moderate to severe cancer pain that is not controlled adequately with non-opioid medications) participants, the initial dose of tapentadol PR will be 25 milligram (mg) twice daily. Participants will receive the same dose of tapentadol PR for the first 2 days of the dose adjustment period and from Day 3, the dose can be titrated as per the Investigator's discretion up to Day 14. After that participants will receive fixed dose regimen for 5 days at the same dose as that used at the end of the dose adjustment period. Efficacy will primarily be evaluated by sustained pain control for the 5 day fixed dose phase. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid-Naive Participants (Tapentadol PR) | Experimental | Drug: Tapentadol PROpioid-naive participants are defined as those who had moderate to severe cancer pain that is not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) is duration between start of treatment to day before initial dose in the maintenance period. Treatment will be initiated with tapentadol prolonged release (JNS024PR, PR) 25 milligram (mg) oral tablet twice daily. Dose will be increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit will be 500 mg per day. Participants will then be assigned to the treatment in the maintenance period (15-19 days). The maintenance period is duration between the first dose and the final assessment in the maintenance period. Participants will receive tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period. |
| Opioid-Switch Participants (Tapentadol PR) | Experimental | Drug: Tapentadol PROpioid-switching participants are defined as those who had moderate to severe cancer pain that is controlled sufficiently with opioid therapy. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) is duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR is selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily is given depending on daily dose of opioid at completion of Screening period. Maximum dose limit is 500 mg per day. Participants will then be assigned to treatment in maintenance period (15-19 days). Maintenance period is defined as duration between first dose and final assessment in maintenance period. Participants will receive tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Opioid switching participants should meet the following criteria from a to c: a) Participants with cancer pain b) previously were on opioid medications (morphine sustained release preparations [120 milligram per day {mg/day} or less], oxycodone hydrochloride sustained release tablets [80 mg/day or less], fentanyl transdermal [through the skin] application system [4.2 mg or less]) c) had achieved adequate pain control with opioid therapy
- Opioid naive participants should meet the following criteria from a to b: a) Participants with cancer pain b) should not have received any pain control therapy with opioids (excluding narcotic antagonist analgesics [drug used to control pain])
- Definite diagnosis of any type of cancer, which has been notified to the participant
- Participants who can be hospitalized during the treatment period
- Participant who can record 11 point Numerical Rating Scale (NRS) and 100 millimeter (mm) Visual Analog Scale (VAS) scores appropriately throughout the study
Key exclusion criteria (5 listed)
- Participants with bradyarrhythmia (slow, irregular heartbeats)
- History of mild or moderate traumatic (causing damage, like a toll used to crush tissue) encephalopathy, cerebral (having to do with the cerebrum) infarction (death of tissue because of lack of blood supply) or transient ischemic (decreased oxygen in a tissue [usually because of decreased blood flow]) attack within 1 year before informed consent
- Previous or concurrent epilepsy (seizure disorder) or convulsive diseases accompanied by disturbance of consciousness
- Previous or concurrent alcohol dependence or narcotic abuse
- History of active hepatitis (inflammation of the liver) B or C within 3 months before informed consent
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 |
|---|---|---|
| Tapentadol PRAlso: Tapentadol hydrochloride, JNS024Tapentadol PR tablets will be administered orally twice daily initiated at dose of 25 mg. Dose will be adjusted as per Investigator's discretion. Maximum dose limit is 500 mg per day. Total duration of treatment is 19 days. | Drug | Opioid-Naive Participants (Tapentadol PR), Opioid-Switch Participants (Tapentadol PR) |
Primary outcome
Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase
Time frame: Day 15 up to Day 19
Percentage of participants with sustained pain control for 5 day fixed dose phase were the participants who completed 5 day maintenance period, whose mean Numerical Rating Scale (NRS) score during the fixed dose phase and which was assessed immediately before giving each dose was less than 4 and the number of rescue doses per day for fixed dose phase was 2 or less. Pain intensity scores were recorded 0 to 30 minutes before dose on 11 point NRS where 0 = no pain and 10 = severest pain imaginable.
9 secondary outcomes
Percentage of Participants Who Achieve Dose Adjustment
Time frame: Day 3 up to Day 14
Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale
Time frame: Baseline (Average of Day -1 and Day 0 morning scores), Day 20
Pain Assessment Using Visual Analog Scale (VAS) Score
Time frame: Baseline and Day 19
Rescue Doses
Time frame: Day 12, 13, 14, 15, 16, 17, 18 and 19
Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy
Time frame: Baseline up to 7 days after last dose of study treatment
Sleep Questionnaire Regarding Time to Sleep and Total Time Slept
Time frame: Pre-dose (Day 1) and Day 20
Sleep Questionnaire Regarding Number of Awakenings
Time frame: Pre-dose (Day 1) and Day 20
Sleep Questionnaire Regarding the Quality of Sleep
Time frame: Pre-dose (Day 1) and Day 20
Patient's Global Impression of Change (PGI-C)
Time frame: Day 19
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tapentadol PR in people with Pain and Cancer, run by Janssen Pharmaceutical K.K. at 21 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 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 29 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?
Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase (time frame: Day 15 up to Day 19). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2013.