A Study of JNS020QD in Patients With Chronic Pain
A Phase 3 Study of JNS020QD in Patients With Chronic Pain
2 other identifiers
interventional
77
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 chronic-pain
Started Oct 2011
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 8, 2011
CompletedFirst Posted
Study publicly available on registry
December 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMarch 24, 2014
March 1, 2014
1.4 years
December 8, 2011
March 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
At Week 4
Secondary Outcomes (1)
Proportion of patients who achieve dose-adjustment
Days 19-21
Study Arms (1)
JNS020QD
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Unknown Facility
Asahikawa, Japan
Unknown Facility
Chiba, Japan
Unknown Facility
Isesaki, Japan
Unknown Facility
Izumo, Japan
Unknown Facility
Kawasaki, Japan
Unknown Facility
Kobe, Japan
Unknown Facility
Matsumoto, Japan
Unknown Facility
Nishinomiya, Japan
Unknown Facility
Ohtsu, Japan
Unknown Facility
Okayama, Japan
Unknown Facility
Osaka, Japan
Unknown Facility
Saga, Japan
Unknown Facility
Sagamihara, Japan
Unknown Facility
Sapporo, Japan
Unknown Facility
Sendai, Japan
Unknown Facility
Toyama, Japan
Unknown Facility
Yamagata, Japan
Unknown Facility
Yamaguchi, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutical K.K., Japan Clinical Trial
Janssen Pharmaceutical K.K.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2011
First Posted
December 15, 2011
Study Start
October 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
March 24, 2014
Record last verified: 2014-03