NCT00745069

Brief Summary

The purpose of this study was to examine a low and high dose of tapentadol extended release tablet taken orally twice a day to reduce pain in subjects suffering from chronic moderate to severe pain due to osteoarthritis of the knee during a 4-week period. Subjects steadily increased their dose up to the low (100 mg) or high (200 mg) dose. Pain relief was compared to subjects taking placebo tablets or oxycodone extended release tablet, 20 mg. The serum concentrations and safety of tapentadol and oxycodone were also examined.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
670

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_2

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

July 1, 2004

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2008

Completed
Last Updated

May 18, 2011

Status Verified

April 1, 2010

First QC Date

August 29, 2008

Last Update Submit

May 17, 2011

Conditions

OsteoarthitisChronic PainKnee Pain

Keywords

TapentadolOsteoarthritisAnalgesiaChronic pain

Outcome Measures

Primary Outcomes (1)

  • Average pain intensity over the preceding 24 hours evaluated at the last timepoint or 29 days using a visual scale.

Secondary Outcomes (1)

  • Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at the last timepoint or 29 days

Interventions

tapentadol HClDRUG

Eligibility Criteria

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

You may qualify if:

  • Subjects with a clinical diagnosis of osteoarthritis of the knee based symptoms and/or radiographic criteria present for at least 3 months
  • Moderate to severe chronic pain due to knee osteoarithritis

You may not qualify if:

  • Previously opioid treated subject who had a history of withdrawal after cessation of the opioid
  • History of seizure disorder, psychiatric disease and history of head trauma requiring evaluation by hospital based staff, or unconsciousness of unknown origin. Subjects who, in the investigator's judgment, have well-controlled depression or anxiety disorder may participate
  • Subjects with history of uncontrolled hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 95 mmHg)
  • Intake of tricyclic antidepressants, serotonin norepinephrine reuptake inhibitors, barbiturates, neuroleptics, monoamine oxidase inhibitors, and antiparkinsonian drugs within the 30 days prior to the screening visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Eichenbaum G, Gohler K, Etropolski M, Steigerwald I, Pergolizzi J, Kim M, Vorsanger G. Does tapentadol affect sex hormone concentrations differently from morphine and oxycodone? An initial assessment and possible implications for opioid-induced androgen deficiency. J Opioid Manag. 2015 May-Jun;11(3):211-27. doi: 10.5055/jom.2015.0270.

    PMID: 25985806DERIVED

Related Links

MeSH Terms

Conditions

Chronic PainOsteoarthritisAgnosia

Interventions

Tapentadol

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 29, 2008

First Posted

September 1, 2008

Study Start

July 1, 2004

Study Completion

August 1, 2005

Last Updated

May 18, 2011

Record last verified: 2010-04