NCT00635349

Brief Summary

The purpose of this study is to compare the effectiveness of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg maintenance with that of non-steroidal anti-inflammatory drugs (NSAIDs) maintenance in participants with knee osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) whose pain was relieved after the add-on treatment of tramadol hydrochloride to NSAIDs.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2007

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

May 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

June 24, 2013

Completed
Last Updated

July 22, 2013

Status Verified

July 1, 2013

Enrollment Period

1.9 years

First QC Date

March 6, 2008

Results QC Date

May 2, 2013

Last Update Submit

July 16, 2013

Conditions

Osteoarthritis

Keywords

WOMACKnee osteoarthritis painPain intensityTramadolAcetaminophenMeloxicamAceclofenac

Outcome Measures

Primary Outcomes (1)

  • Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85

    The WOMAC is a self-administered and health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a visual analog scale (VAS) of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best.

    Day 29 and Day 85

Secondary Outcomes (6)

  • Change From Day 29 in Pain Intensity Score at Day 85

    Day 29 and Day 85

  • Number of Participants With Pain Relief

    Day 29, Day 57 and Day 85

  • Number of Participants With Overall Assessment on Study Drug by Participants

    Day 85

  • Number of Participants With Overall Assessment on Study Drug by Investigator

    Day 85

  • Number of Participants With Categorical Swelling

    Day 29, Day 57 and Day 85

  • +1 more secondary outcomes

Study Arms (2)

Non-steroidal Anti-inflammatory Drug (NSAIDs)

ACTIVE COMPARATOR

Participants will receive fixed dose combination of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who will have the numeric rating scale score 4 or less on Day 29 will be randomly assigned to the treatment of NSAIDs to receive either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85.

Drug: MeloxicamDrug: AceclofenacDrug: Tramadol Hydrochloride Plus Acetaminophen

Tramadol Hydrochloride Plus Acetaminophen

EXPERIMENTAL

Participants will receive fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who will have the numerical rating scale score 4 or less on Day 29 will be randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose will be 8 tablets).

Drug: MeloxicamDrug: AceclofenacDrug: Tramadol Hydrochloride Plus Acetaminophen

Interventions

MeloxicamDRUG

Meloxicam 7.5 mg or 15 mg per day along with fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day from Day 1 to Day 28, and meloxicam 7.5 mg or 15 mg per day from Day 29 to Day 85.

Non-steroidal Anti-inflammatory Drug (NSAIDs)Tramadol Hydrochloride Plus Acetaminophen
AceclofenacDRUG

Aceclofenac 100 mg twice a day along with fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day from Day 1 to Day 28, and aceclofenac 100 mg twice a day from Day 29 to Day 85.

Non-steroidal Anti-inflammatory Drug (NSAIDs)Tramadol Hydrochloride Plus Acetaminophen
Tramadol Hydrochloride Plus AcetaminophenDRUG

Fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with NSAIDs (meloxicam \[7.5 mg or 15 mg once daily\] or aceclofenac \[100 mg twice daily\]) from Day 1 to Day 28, and fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose will be 8 tablets).

Non-steroidal Anti-inflammatory Drug (NSAIDs)Tramadol Hydrochloride Plus Acetaminophen

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants who have suffered from knee osteoarthritis at least for one year and meet the criteria of American College of Rheumatology
  • Participants who are taking stable dose of meloxicam 7.5 milligram (mg) or 15 mg daily or aceclofenac 100 mg twice a day at least for four weeks
  • Participants whose mean pain intensity has been 5 or higher on the numeric rating scale (NRS) for the last 48 hours
  • Participants whose general health conditions are favorable, according to the criteria below: Medical and medication history, Physical examination before the study medication administration, Vital signs: Blood pressure, pulse, Clinical laboratory tests: Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvate transaminase (SGPT) less-than or equal to (=\<) 2 X normal range, Renal function: Creatinine less than (\<) 2.0 milligrams per deciliter (mg/dl)
  • Female participants of childbearing potential to use the proper contraceptive methods during the study period (Urine pregnancy test prior to the study participation should be negative)

You may not qualify if:

  • Participants who are applicable to Kellgren and Lawrence grade
  • Participants who had failed tramadol treatment before or stopped taking tramadol due to adverse event(s)
  • Participants who are applicable to one of the following conditions: Rheumatoid arthritis, Ankylosing spondylitis, Active gout or active pseudo-gout, Diagnosis of fibromyalgia (according to ACR Criteria), Anserine bursitis, Major trauma of the target joint within six months prior to the study medication administration, Infection of the target joint within six months prior to the study medication administration, Apparent avascular necrosis of the target joint within six months prior to the study medication administration, Anatomical deformities of the target joint, which may interfere with assessment of the target joint, Surgical procedures associated with the target joint within one year prior to the study medication administration, Arthroscopic procedures associated with the target joint within six months prior to the study medication administration
  • Participants who have one of the following diseases: Significantly unstable diseases such as sleep disorder (e.g., sleep apnea or narcolepsy) or dementia, Functional damage or disease which may cause malabsorption, excessive accumulation, or metabolism or excretion disorder
  • Participants who are pregnant or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OsteoarthritisPain

Interventions

MeloxicamaceclofenacTramadolAcetaminophen

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazinesSulfur CompoundsOrganic ChemicalsThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanolsHexanolsFatty AlcoholsAlcoholsDimethylaminesMethylaminesAminesLipidsAcetanilidesAnilidesAmidesAniline Compounds

Limitations and Caveats

There was no wash-out period after Day 28 to show drug efficacy in participants whose pain was already relieved and results were not meet the objective by setting inappropriate non-inferiority limit by applying WOMAC total score in hypothesis.

Results Point of Contact

Title
Clinical Research Director
Organization
Janssen Korea / 25F, LS Yongsan Tower, 191 Hankangro 2-Ga, Yongsan-Gu, Seoul 140-702 Korea
82-2-2094-4518

Study Officials

  • Janssen Korea, Ltd. Clinical Trial

    Janssen Korea, Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2008

First Posted

March 13, 2008

Study Start

May 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

July 22, 2013

Results First Posted

June 24, 2013

Record last verified: 2013-07