A Study of JNS020QD in Patients With Chronic Pain

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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