A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain
A Randomized, Double-Blind, Active Controlled, Optimal Dose Titration, Multicenter Study to Evaluate the Safety and Efficacy of Oral JNS024 Extended Release (ER) in Japanese and Korean Subjects With Moderate to Severe Chronic Malignant Tumor Related Cancer Pain
2 other identifiers
interventional
343
2 countries
52
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of R331333 (referred to as JNS024 Extended-Release (ER) or CG5503) compared with an active comparator (oxycodone Controlled Release (CR)) in Japanese and Korean patients with chronic, malignant, tumor-related cancer pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pain
Started Aug 2010
Typical duration for phase_3 pain
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2010
CompletedFirst Posted
Study publicly available on registry
July 19, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
January 15, 2014
CompletedJuly 21, 2017
December 1, 2013
2 years
July 15, 2010
August 9, 2013
June 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale
The patients recorded their average pain intensity over the past 24 hours once daily in the evening and at the same time as much as possible (eg, 10:00 PM) throughout the study in response to the following question: "What has your average pain level been for the past 24 hours, where 0=no pain and 10=pain as bad as you can imagine." The score at 3 days before the completion of study drug administration was defined as the average pain intensity score averaged over the last 3 days before completion of study drug administration.
Baseline, Last 3 Days of Study Drug Administration (4 weeks)
Secondary Outcomes (6)
Percentage of Patients in Patient Global Impression of Change (PGIC) Score Categories
Baseline, Endpoint of the 4-week Treatment Period
Frequency of Rescue Medication Use for the Double-blind Treatment Period
4 weeks
Total Daily Dose of Rescue Medication Use for the Double-blind Treatment Period
4 weeks
Proportion of Patients With Various Levels of Pain Improvement (Responders)
Baseline, Last 3 Days of Study Drug Administration (4 weeks)
Proportion of Patients Entering the Maintenance Period
4 weeks
- +1 more secondary outcomes
Study Arms (2)
001
EXPERIMENTALR331333 (referred to as JNS024 ER or CG5503) One 25 mg to 200 mg capsule twice daily for 4 weeks.
002
ACTIVE COMPARATOROxycodone CR One 5 mg to 40 mg capsule twice daily for 4 weeks.
Interventions
One 25 mg to 200 mg capsule twice daily for 4 weeks.
Eligibility Criteria
You may qualify if:
- Documented clinical diagnosis of any type of cancer
- Diagnosis of chronic malignant tumor-related cancer pain with an average score for pain intensity in the past 24 hours of \>=4 on the 11-point numerical rating scale (NRS) on the day of randomization (Day -1)
- Have not received treatment with opioid analgesics within 28 days before screening (Note: codeine phosphate \[\<=60 mg/d\] or dihydrocodeine phosphate \[\<=30 mg/d\] for antitussive use are allowed)
- Dissatisfied with pain relief by the current treatment and for whom the investigator or designee judges that treatment with opioid analgesics is required
You may not qualify if:
- Have complicated with uncontrolled/clinically significant arrhythmia
- Have previous or concurrent presence of any disease which may develop increased intracranial pressure, disturbance of consciousness, lethargy, or respiratory problems such as traumatic encephalopathy with cerebral contusion, intracranial hematoma, disturbance of consciousness, brain tumor, cerebral infarction, transient ischemic attack, epilepsy or convulsive diseases
- Have history of alcohol and/or drug abuse
- Have any disease for which opioids are contraindicated such as serious respiratory depression of serious chronic obstructive pulmonary disease, bronchial asthma attack, cardiac failure secondary to chronic pulmonary disease, paralytic ileus, status epileptics, tetanus, strychnine poisoning, acute alcohol poisoning, hypersensitivity to opium alkaloid, hemorrhagic colitis, or bacterial diarrhea
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
Unknown Facility
Chiba, Japan
Unknown Facility
Fukui, Japan
Unknown Facility
Fukushima, Japan
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Fukuyama, Japan
Unknown Facility
Fushimi, Japan
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Hamamatsu, Japan
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Hirosaki, Japan
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Hitachi, Japan
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Itami, Japan
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Iwakuni, Japan
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Izumo, Japan
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Kamogawa, Japan
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Kanuma, Japan
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Kobe, Japan
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Kumagaya, Japan
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Kumamoto, Japan
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Kure, Japan
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Kyoto, Japan
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Matsumoto, Japan
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Matsusaka, Japan
Unknown Facility
Miyazaki, Japan
Unknown Facility
Nagoya, Japan
Unknown Facility
Natori, Japan
Unknown Facility
Niigata, Japan
Unknown Facility
Ogōri, Japan
Unknown Facility
Ohta, Japan
Unknown Facility
Okayama, Japan
Unknown Facility
Osaka, Japan
Unknown Facility
Saga, Japan
Unknown Facility
Saku, Japan
Unknown Facility
Sapporo, Japan
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Sendai, Japan
Unknown Facility
Sunto, Japan
Unknown Facility
Takarazuka, Japan
Unknown Facility
Takasaki, Japan
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Tokyo, Japan
Unknown Facility
Tomakomai, Japan
Unknown Facility
Toyama, Japan
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Toyonaka, Japan
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Ube, Japan
Unknown Facility
Yamagata, Japan
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Yamanashi, Japan
Unknown Facility
Yokohama, Japan
Unknown Facility
Busan, South Korea
Unknown Facility
Chungcheongbuk-Do, South Korea
Unknown Facility
Daegu, South Korea
Unknown Facility
Deajun, South Korea
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Gyeonggi-do, South Korea
Unknown Facility
Incheon, South Korea
Unknown Facility
Jinju, South Korea
Unknown Facility
Seoul, South Korea
Unknown Facility
Suwon, South Korea
Related Publications (1)
Imanaka K, Tominaga Y, Etropolski M, van Hove I, Ohsaka M, Wanibe M, Hirose K, Matsumura T. Efficacy and safety of oral tapentadol extended release in Japanese and Korean patients with moderate to severe, chronic malignant tumor-related pain. Curr Med Res Opin. 2013 Oct;29(10):1399-409. doi: 10.1185/03007995.2013.831816. Epub 2013 Aug 23.
PMID: 23937387DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Janssen Pharm KK Japan
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2010
First Posted
July 19, 2010
Study Start
August 1, 2010
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
July 21, 2017
Results First Posted
January 15, 2014
Record last verified: 2013-12