MedTrace Logo

A Study of the Tolerability of Titrated Dose Tramadol/Acetaminophen Combination Tablet in Korean Patients With Osteoarthritis

NCT01063842 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2010-02-05

No results posted yet for this study

Summary

The purpose of this study is to compare the number of osteoarthritis patients receiving titrated or increasing doses of tramadol hydrochloride/acetaminophen combination tablet (titration group) who discontinue treatment due to adverse events to the number of patients receiving a non-titrated dose of tramadol/hydrochloride/acetaminophen combination tablet who discontinue treatment due to adverse events.

Conditions

Interventions

DRUG

tramadol hydrochloride /acetaminophen

1 tablet of tramadol hydrochloride/acetaminophen three times daily without titration for 14 days.

DRUG

tramadol hydrochloride / acetaminophen and placebo

1 tablet of tramadol/acetaminophen in the morning, 1 tablet of placebo in the afternoon and evening for 3 days, then 1 tablet of tramadol/acetaminophen in the morning, evening and 1 tablet of placebo in the afternoon for 4 days, then 1 tablet of tramadol/acetaminophen 3 times daily for next 7 days

Sponsors & Collaborators

  • Janssen Korea, Ltd., Korea

    lead INDUSTRY

Principal Investigators

  • Janssen Korea, Ltd. Clinical Trial · Janssen Korea, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Completion
2006-05-31

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 NCT01063842 on ClinicalTrials.gov