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

NCT00736853 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2013-09-26

Study results available
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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).

Conditions

Interventions

DRUG

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).

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.

DRUG

Placebo (Double-Blind)

Matching placebo will be given up to 4 weeks.

Sponsors & Collaborators

  • Janssen Pharmaceutical K.K.

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutical K.K. Clinical Trial · Janssen Pharmaceutical K.K.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00736853 on ClinicalTrials.gov