A Long-term Efficacy and Safety Study of Tramadol Hydrochloride Plus Acetaminophen (JNS013) in Japanese Participants With Chronic Pain

NCT ID: NCT00736957

Last Updated: 2014-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 219 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-11-30

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride plus acetaminophen (JNS013) with long term administration in participants with chronic pain.

Detailed Description

This is an open-label (both physician and participant know the name of the study drug), non-randomized, multicenter (when more than one hospital or medical school team work on a medical research study) and long-term efficacy and safety study of JNS013 (combination of tramadol hydrochloride (TRAM) with acetaminophen [APAP]) in participants with chronic pain (aching sensation that persists for more than a few months. It may or may not be associated with trauma or disease, and may persist after the initial injury has healed. Its localization, character, and timing are more vague than with acute pain). This study consists of 4 periods; screening period: 1 week, treatment period I: 4 weeks, treatment period II: 48 weeks and follow-up period: 1 week. During Treatment Period I, restrictions on concomitant treatments will be established and the participants will be treated with one or two tablets of JNS013, four times daily for four weeks. During Treatment Period II, the participants will be treated for 48 weeks using the same dosing method and dose level for JNS013 as was used during Treatment Period I, permitting modifications to the concomitant drugs/therapies as during normal medical care. Throughout both Treatment Period I and Treatment Period II, the decision will be made to permit the participants to select to use either one or two tablets of JNS013 per dose according to the extent of the participant's pain and tolerability. The total duration of treatment period will be of 52 weeks. Efficacy will be assessed using change from baseline in Visual Analogue Scale for pain (VAS24) score at the pre-defined time point until Week 52. Participants safety will be monitored throughout the study.

Conditions

Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tramadol HCL plus Acetaminophen

Group Type: EXPERIMENTAL

Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013)

Intervention Type: DRUG

Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets will be given orally four times daily (maximum dose is 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments will be established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval will be of at least 4 hours.

Interventions

Tramadol Hydrochloride (HCL) plus Acetaminophen (JNS013)

Tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg (JNS013) one or two tablets will be given orally four times daily (maximum dose is 8 tablets per day) for 4 weeks during treatment period 1 (restrictions on concomitant treatments will be established) and for 48 weeks during treatment period 2 (permitting modifications to the concomitant drugs/therapies). The dosing interval will be of at least 4 hours.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants whose pain cannot be controlled sufficiently with at least 14-day continuous treatment with identical oral non steroid anti inflammatory drugs (NSAIDs) at a usual maximum dose during 3 months prior to this study
• Ambulatory participants without need for any supportive device or assistance during daily life
• Outpatients
• Participants 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
• Sustention of chronic pain due to Osteo Arthritis (OA), Low Back Pain (LBP), Rheumatoid Arthritis (RA), Neck Shoulder Arm Syndrome (NSAS), Diabetic Neuropathy (DN), Post herpetic Neuralgia (PHN) or other for at least 3 months

Exclusion Criteria

• Participants with conditions for which opioids are contraindicated
• Participants with conditions for which APAP are contraindicated
• Participants with history of convulsion or the possibility of convulsive seizure
• Participants with concurrent, previous, or possible alcohol dependence, drug dependence, or narcotic addiction
• Pregnant Participants or those who may be pregnant, lactating mothers, and Participants who wish pregnancy during the study period.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Chikushi, , Japan

Chūō, , Japan

Fukui, , Japan

Fukuoka, , Japan

Hiratsuka, , Japan

Ichikawa, , Japan

Kashiwa, , Japan

Komatsu, , Japan

Kukichūō, , Japan

Kumamoto, , Japan

Kyoto, , Japan

Mihara, , Japan

Nagoya, , Japan

Nerima City, , Japan

Obihiro, , Japan

Ogi, , Japan

Ohta-Ku, , Japan

Osaka, , Japan

Tagawa, , Japan

Taito-Ku, , Japan

Takaoka, , Japan

Tokyo, , Japan

Urayasu, , Japan

Yame, , Japan

Yokohama, , Japan

Countries

Japan

Other Identifiers

JNS013-JPN-05

Identifier Type: -

Identifier Source: secondary_id

CR015115

Identifier Type: -

Identifier Source: org_study_id