NCT01063842

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2005

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2009

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 5, 2010

Completed
Last Updated

February 5, 2010

Status Verified

February 1, 2010

First QC Date

October 8, 2009

Last Update Submit

February 4, 2010

Conditions

Osteoarthritis

Keywords

Drop-out rateOsteoarthritisTolerabilityTramadolAcetaminophen

Outcome Measures

Primary Outcomes (1)

  • Study Discontinuation rate due to adverse event

    Throughout the study from start of study drug until final visit, Day 14

Secondary Outcomes (5)

  • comparison of the pain intensity scores between the 2 treatment groups

    Day 0, Day 14

  • comparison of the pain relief scores between the 2 treatment groups

    Day 14

  • comparison of the WOMAC (Western and Ontario Mcmaster) total scores between the 2 treatment groups.The WOMAC index is a 24-item questionnaire completed by the patient and focusing on pain, stiffness and function related to osteoarthritis of knee and hip

    Day 0, Day 14

  • comparison of the overall assessment of patient between the 2 treatment groups

    Day 14

  • comparison of the overall assessment of investigator between the 2 treatment groups

    Day 14

Study Arms (2)

001

EXPERIMENTAL

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

Drug: tramadol hydrochloride / acetaminophen and placebo

002

ACTIVE COMPARATOR

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

Drug: tramadol hydrochloride /acetaminophen

Interventions

tramadol hydrochloride /acetaminophenDRUG

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

002
tramadol hydrochloride / acetaminophen and placeboDRUG

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

001

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have osteoarthritis of the knee for at least one year based on clinical and radiological criteria
  • Must have been on a stable daily dose of a NSAID for at least two weeks prior to randomization
  • Must have a pain intensity Numeric Rating Scale (NRS) score 4 or more as a average intensity for 48 hours. (On a Numeric Rating Scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable)

You may not qualify if:

  • Have taken tramadol HCL within 14 days prior to randomization
  • Have taken acetaminophen within 7 days prior to randomization
  • Have received other pain medication (including topical medication and/or anesthetics), sedative hypnotics, or muscle relaxants within a period of less than five half-lives of the given medication prior to randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Interventions

UltracetTramadolAcetaminophen

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsAcetanilidesAnilidesAmidesAniline Compounds

Study Officials

  • Janssen Korea, Ltd. Clinical Trial

    Janssen Korea, Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 8, 2009

First Posted

February 5, 2010

Study Start

August 1, 2005

Study Completion

May 1, 2006

Last Updated

February 5, 2010

Record last verified: 2010-02