An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain

NCT ID: NCT00736853

Last Updated: 2013-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 321 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-01-31

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride plus acetaminophen (JNS013) in participants with chronic pain accompanied by osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) of the knee or low back pain (acute or chronic pain in the lumbar or sacral regions) which cannot be controlled sufficiently with non-steriodal anti-inflammatory drugs (NSAIDs).

Detailed Description

This is a multi-center (when more than one hospital or medical school team work on a medical research study), double-blind (test or experiment in which neither the person giving the treatment nor the participant knows which treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel group comparison study. The total duration of the study will be 11 weeks and consists of 4 periods; a pre-observation period (4 weeks), open-label period (2 weeks), double-blind period (4 weeks) and follow-up period (1 week). Participants will receive tramadol hydrochloride plus acetaminophen tablets orally 4 times daily for 2 weeks with no less than 4-hour intervals (up to 8 tablets per day) during the open-label period and the dose will be fixed for each participant in the latter 1 week. During the double-period participants will receive tramadol hydrochloride plus acetaminophen tablets or placebo at the same dose as used for the latter 1 week of the open-label period for up to 4 weeks. Efficacy will be primarily evaluated by number of participants with insufficient pain relief after the start of double-blind period. Participant's safety will be monitored throughout the study.

Conditions

Pain

Keywords

Chronic pain; Acetoaminophen; Tramadol; Osteoarthritis of the knee; Low back pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tramadol Hydrochloride Plus Acetaminophen (Open-Label)

Group Type: EXPERIMENTAL

Tramadol Hydrochloride Plus Acetaminophen (Open-Label)

Intervention Type: DRUG

Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily will be given for one week; dose level will be fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose will be 8 tablets).

Tramadol Hydrochloride Plus Acetaminophen (Double Blind)

Group Type: EXPERIMENTAL

Tramadol Hydrochloride Plus Acetaminophen (Double-Blind)

Intervention Type: DRUG

Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose \[number of tablets\] as that for the second week in the open-label period) will be given 4 times daily up to 4 weeks.

Placebo (Double-Blind)

Group Type: PLACEBO_COMPARATOR

Placebo (Double-Blind)

Intervention Type: DRUG

Matching placebo will be given up to 4 weeks.

Interventions

Tramadol Hydrochloride Plus Acetaminophen (Open-Label)

Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily will be given for one week; dose level will be fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose will be 8 tablets).

Intervention Type: DRUG

Tramadol Hydrochloride Plus Acetaminophen (Double-Blind)

Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose \[number of tablets\] as that for the second week in the open-label period) will be given 4 times daily up to 4 weeks.

Intervention Type: DRUG

Placebo (Double-Blind)

Matching placebo will be given up to 4 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants with sustention of chronic pain associated with OA or LBP for at least 3 months
• Participants 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 participants without need for any supportive device or assistance during daily life

Exclusion Criteria

• Participants with conditions for which opioids are contraindicated
• Participants with conditions for which acetaminophen is 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

Aichi, , Japan

Amagasaki, , Japan

Chiba, , Japan

Edogawa City, , Japan

Fukuoka, , Japan

Fukushima, , Japan

Iruma, , Japan

Kagoshima, , Japan

Kawasaki, , Japan

Kumagaya, , Japan

Kurume, , Japan

Meguro City, , Japan

Minato, , Japan

Niigata, , Japan

Ohta-Ku, , Japan

Okazaki, , Japan

Sagamihara, , Japan

Setagaya City, , Japan

Shibuya City, , Japan

Shinjuku-Ku, , Japan

Countries

Japan

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=423&filename=CR015112_CSR.pdf

A Phase III Study of JNS013 in Patients with Chronic Pain

Other Identifiers

JNS013-JPN-04

Identifier Type: -

Identifier Source: secondary_id

NCT00736853

Identifier Type: -

Identifier Source: secondary_id

CR015112

Identifier Type: -

Identifier Source: org_study_id