Status:
COMPLETED
A Study of JNS020QD in Patients With Chronic Pain
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Chronic Pain
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01493245
Start Date
October 1 2011
End Date
March 1 2013
Last Update
March 24 2014
Active Locations (18)
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1
Asahikawa, Japan
2
Chiba, Japan
3
Isesaki, Japan
4
Izumo, Japan