A Verification Study of a Long-Term Use 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 assess the effectiveness and safety of JNS013 with long-term administration (52 weeks) to patients with chronic pain poorly controlled by NSAIDs.

Official title: A Study of a Long-Term Administration of JNS013 in Patients With Chronic Pain

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: VAS24 changes and the time course changes, pain intensity difference (PID) and the time course, time course changes of pain relief rating (PAR), time course changes of sum of PID and PAR, overall pain relief rating, SF-36, 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 confirm the safety of JNS013 with long-term administration patients with chronic pain and the effectiveness of JNS013 in diseases associated with chronic pains due to not only knee osteoarthritis (OA) or low back pain (LBP) but rheumatoid arthritis(RA), neck-shoulder-arm syndrome (NSAS), diabetic neurogenic pain (DN) or postherpetic neuralgia(PHN) etc. This study is designed as an open-label (both physician and patient know the name of the study drug), uncontrolled, multicenter study. The duration of treatment is for up to 52 weeks. Of the duration, the first 4 weeks in treatment period is described as treatment period I. During treatment period I, JNS013 will be administered without allowing changes in the content of concomitant medications/therapies, and the effectiveness in various chronic pains will be confirmed. Subsequently, in treatment period II (after 5th week in treatment period), no concomitant medications/therapies will be restricted, and the safety of JNS013 treatment under the normal clinical status will be confirmed. 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 Patients will select one or two tablets of JNS013 per administration depending on their severity of pain and tolerability. Treatment will be given to patients 4 times daily at no less than 4-hour intervals (up to i8 tablets per day). The treatment period will be for up to 52 weeks. Total study periods: 54 weeks. Screening period: 1 week. Treatment period I: 4 weeks. Treatment period II: 48 weeks Follow-up period: 1 week. Safety evaluations: Adverse events reporting, laboratory test values, blood pressure/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 1 or 2 tablets of JNS013 per administration according to the severity of pain and tolerability by each patient. The treatment period will be for up to 52 weeks.

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

Criteria:

Inclusion Criteria:

- Sustention of chronic pain due to OA, LBP, RA, NSAS, DN, PHN or other 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

- Patients who do not plan to change the therapeutic policy and content of the

medications for underlying disease during screening period to the end of Treatment Period I

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

811-1201 Fukuoka, Japan; Recruiting

849-0306 Saga, Japan; Recruiting

910-0067 Fukui, Japan; Recruiting

141-0022 Tokyo N/A, Japan; Recruiting

815-0032 Fukuoka, Japan; Recruiting

178-0063 Tokyo, Japan; Recruiting

451-0052 Nagoya, Japan; Recruiting

279-0012 Chiba, Japan; Recruiting

176-0005 Tokyo, Japan; Recruiting

111-0032 Tokyo, Japan; Recruiting

272-0133 Chiba, Japan; Recruiting

104-0061 Tokyo, Japan; Recruiting

923-0961 Ishikawa, Japan; Recruiting

143-0015 Tokyo, Japan; Recruiting

254-0046 Kanagawa, Japan; Recruiting

116-0011 Tokyo N/A, Japan; Recruiting

615-0035 Kyoto, Japan; Recruiting

723-0052 Hiroshima, Japan; Recruiting

060-0062 Hokkaido, Japan; Recruiting

277-0004 Chiba, Japan; Recruiting

834-0024 Fukuoka, Japan; Recruiting

080-0016 Hokkaido, Japan; Recruiting

933-0816 Toyama, Japan; Recruiting

825-0005 Fukuoka, Japan; Recruiting

236-0037 Kanagawa, Japan; Recruiting

814-0033 Fukuoka, Japan; Recruiting

227-0043 Kanagawa, Japan; Recruiting

862-0976 Kumamoto, Japan; Recruiting

559-0011 Osaka, Japan; Recruiting

346-0003 Saitama, Japan; Recruiting

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

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