A Confirmatory Study of JNS013 in Patients With Chronic Pain

Condition(s) targeted: Pain

Intervention: Tramadol hydrochloride; Acetaminophen; JNS013 (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Janssen Pharmaceutical K.K.

Official(s) and/or principal investigator(s):
Janssen Pharmaceutical K.K. Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutical K.K.

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

The purpose of this study is to evaluate the analgesic effectiveness and safety of JNS013 in patients with chronic pain accompanied by osteoarthritis of the knee or lumbago which cannot be controlled sufficiently with NSAIDs in a placebo-controlled manner.

Official title: A Phase 3 Study of JNS013 in Patients With Chronic Pain

Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study

Primary outcome: Time to lack of analgesic efficacy from the start of double-blind period.

Secondary outcome: VAS24 changes and the time course changes, pain intensity difference (PID) and the time course changes, time course changes of pain relief rating (PAR), time course changes of sum of PID and PAR, sum of PIDs at each assessment point, etc.

Detailed description: Since JNS013 is a combination of tramadol hydrochloride (TRAM) acting as a weak opioid with acetaminophen (APAP) inhibiting central COX-3, it is expected to have an intermediate effect between narcotic analgesics and NSAIDs (non-steroid anti-inflammatory drugs). This study was planned to evaluate the effectiveness and safety of JNS013 patients with chronic pain. To increase the accuracy of the confirmatory study, osteoarthritis of the knee (OA) and low back pain (LBP) were selected as target diseases for the study. This is a multicenter, randomized

(patients assigned study drug by chance) - withdrawal, double-blind ( neither patient nor

physician knows the assigned study drug medication name), placebo-controlled, parallel-group study. Patients with lack of analgesic effect of NSAIDs will be enrolled in the study. Patients who meet the criteria for the open-label period will receive JNS013 for 2 weeks, and after that patients who meet the criteria for the double-blind period will be randomized and receive JNS013 or placebo for 4 weeks. The primary efficacy endpoint in this study is time to treatment withdrawal due to lack of effectiveness. In addition, the investigator will assess the safety by handling any untoward medical event (including abnormal changes in laboratory data) that occurred in patients from informed consent through the completion of follow-up period as an adverse event. Besides collection of any untoward medical event, laboratory data, Vital signs and body weight will be measured for safety evaluation. Total Study Period: 11 weeks. Screening Period: 4 weeks. Open-label Period (2 weeks): JNS013 will be administered to patients who meet the criteria for entry into the open-label period. The dose will be selected by each patient, 1 or 2 tablets/times of JNS013, according to the severity of pain and tolerability. JNS013 will orally be administered 4 times daily no less than 4-hour intervals (up to 8 tablets per day) for 2 weeks. During the latter 1 week, the dose will be fixed for each patient. Double-blind Period (4 weeks): Either JNS013 or placebo will be administered to patients who meet the criteria for entry into the double-blind period. The study drug will be administered at the same dose as used for the latter 1 week of the open-label period for up to 4 weeks. It will orally be administered 4 times daily at no less than 4-hour intervals (up to 8 tablets per day). It will be discontinued in patients confirmed to have lack of analgesic effect during the double-blind period. Follow-up Period: 1 week. Safety evaluations: Adverse events reporting, laboratory test values, vital blood/pulse rate, body weight.

JNS013 will be orally administered 4 times daily at least 4-hour intervals (up to 8 tablets per day). The dose will be selected by each patient, 1 or 2 tablets of JNS013, according to the severity of pain and tolerability during 2 weeks of the open-label period. During the latter 1 week, the dose will be fixed for each. In the double-blind period, either JNS013 or placebo will be administered at the same dose as used for the latter 1 week of the open-label period for up to 4 weeks.

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with sustention of chronic pain associated with OA or LBP for at least 3

months

- Patients whose pain cannot be controlled sufficiently with at least 14-day continuous

treatment with identical oral NSAIDs at a usual maximum dose during 3 months prior to this study

- Outpatients

- Ambulatory patients without need for any supportive device or assistance during daily

life

Exclusion Criteria:

- Patients with conditions for which opioids are contraindicated

- Patients with conditions for which APAP are contraindicated

- Patients with history of convulsion or the possibility of convulsive seizure

- Patients with concurrent, previous, or possible alcohol dependence, drug dependence,

or narcotic addiction

- Pregnant patients or those who may be pregnant, lactating mothers, and patients who

wish pregnancy during the study period

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

260-0856 Chiba N/A, Japan; Recruiting

154-0012 Tokyo, Japan; Recruiting

134-0084 Tokyo, Japan; Recruiting

951-8122 Niigata N/A, Japan; Recruiting

444-0852 Aichi, Japan; Recruiting

830-0011 Kurume N/A, Japan; Recruiting

358-0003 Iruma, Japan; Recruiting

892-0826 Kagoshima, Japan; Recruiting

213-0001 Kawasaki, Japan; Recruiting

107-0062 Tokyo, Japan; Recruiting

145-0062 Tokyo, Japan; Recruiting

169-0051 Tokyo, Japan; Recruiting

229-0033 Sagamihara, Japan; Recruiting

212-0011 Kawasaki, Japan; Recruiting

153-0065 Tokyo, Japan; Recruiting

360-0854 Kumagaya, Japan; Recruiting

812-0054, Japan; Recruiting

960-1247 Fukushima N/A, Japan; Recruiting

151-0053 Tokyo, Japan; Recruiting

890-0014 Kagoshima, Japan; Recruiting

358-0011 Iruma, Japan; Recruiting

661-0976 Hyogo, Japan; Recruiting

891-0141 Kagisguna, Japan; Recruiting

480-1103 Aichi, Japan; Recruiting

To learn how to participate in this trial please click here.

Starting date: May 2008
Last updated: September 26, 2008