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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00364533




Registration number
NCT00364533
Ethics application status
Date submitted
11/08/2006
Date registered
15/08/2006
Date last updated
21/04/2014

Titles & IDs
Public title
A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety
Scientific title
A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate Release Formulation in the Treatment of Acute Pain From Total Hip Replacement Surgery Followed by a Voluntary Open-Label Extension
Secondary ID [1] 0 0
R331333PAI3001
Secondary ID [2] 0 0
CR011221
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthroplasty 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tapentadol IR (CG5503)
Treatment: Drugs - Placebo
Treatment: Drugs - Oxycodone HCL IR
Treatment: Drugs - Tapentadol IR (CG5503)

Placebo comparator: 003 - Placebo Fixed Dose Matching placebo for 3 days

Active comparator: 002 - Oxycodone HCL IR Fixed Dose 10 mg BID for 3 days

Experimental: 001 - Tapentadol IR (CG5503) Fixed Dose 50, 75, \& 100 mg BID for 3 days

Other: 004 - Tapentadol IR (CG5503) Flexible Dose q4-6 hr Tapentadol IR 50 \& 100 mg BID for 9 days


Treatment: Drugs: Tapentadol IR (CG5503)
Fixed Dose 50, 75, \& 100 mg BID for 3 days

Treatment: Drugs: Placebo
Fixed Dose Matching placebo for 3 days

Treatment: Drugs: Oxycodone HCL IR
Fixed Dose 10 mg BID for 3 days

Treatment: Drugs: Tapentadol IR (CG5503)
Flexible Dose q4-6 hr Tapentadol IR 50 \& 100 mg BID for 9 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sum of Pain Intensity Difference Over 48 Hours (SPID48)
Timepoint [1] 0 0
48 hours
Secondary outcome [1] 0 0
Time to First Rescue Pain Medication.
Timepoint [1] 0 0
3 days
Secondary outcome [2] 0 0
The SPID at 12, 24, and 72 Hours Relative to First Dose.
Timepoint [2] 0 0
3 days

Eligibility
Key inclusion criteria
* Scheduled to undergo standard primary (first-time) one-sided total hip replacement surgery due to degenerative joint disease (arthritis), not due to some inflammatory process, (eg. infection)
* Baseline pain intensity >= 4 on an 11-point (0 to 10) Pain Intensity rating scale, rated within 30 minutes before randomization
* Women must be postmenopausal, surgically sterile, or practicing or agree to practice an effective method of birth control throughout the study
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients will be excluded from the study if they have a history of seizure disorder or epilepsy
* history of malignancy within the past 2 years before starting the study
* history of alcohol or drug abuse
* evidence of active infections that may spread to other areas of the body
* clinical laboratory values reflecting moderate or severe kidney insufficiency
* currently treated with anticonvulsants, monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or selective norepinephrine reuptake inhibitor (SNRI), (selective serotonin reuptake inhibitor [SSRI] treatments are allowed if taken for at least 30 days before the screening period of the study at an unchanged dose)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2007
Sample size
Target
Accrual to date
Final
367
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
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United States of America
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Indiana
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United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
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North Carolina
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Wisconsin
Country [23] 0 0
Belgium
State/province [23] 0 0
Aalst
Country [24] 0 0
Belgium
State/province [24] 0 0
Genk
Country [25] 0 0
Belgium
State/province [25] 0 0
Gent
Country [26] 0 0
Belgium
State/province [26] 0 0
Leuven
Country [27] 0 0
Canada
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Nova Scotia
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
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Quebec
Country [30] 0 0
Canada
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London
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Finland
State/province [31] 0 0
Helsinki
Country [32] 0 0
Finland
State/province [32] 0 0
Tampere
Country [33] 0 0
Finland
State/province [33] 0 0
Turku
Country [34] 0 0
New Zealand
State/province [34] 0 0
Hamilton
Country [35] 0 0
Spain
State/province [35] 0 0
Cadiz N/A
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
Spain
State/province [37] 0 0
Valencia
Country [38] 0 0
Sweden
State/province [38] 0 0
Borås
Country [39] 0 0
Sweden
State/province [39] 0 0
Hässleholm
Country [40] 0 0
Sweden
State/province [40] 0 0
Uppsala
Country [41] 0 0
Sweden
State/province [41] 0 0
Örebro
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Aberdeen
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United Kingdom
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Birmingham
Country [44] 0 0
United Kingdom
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Edinburgh
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United Kingdom
State/province [45] 0 0
Great Yarmouth
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United Kingdom
State/province [46] 0 0
London
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United Kingdom
State/province [47] 0 0
Middlesex
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United Kingdom
State/province [48] 0 0
Sheffield
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Wigan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Grünenthal GmbH
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to test in patients who have had hip replacement surgery the effectiveness (level of pain control) and the safety of 3 different dose levels of CG5503 compared with placebo and with 10-mg oxycodone during the 72-hour double-blind period and to assess the safety of the drug for 9 days after patients completed the double blind period.
Trial website
https://clinicaltrials.gov/study/NCT00364533
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Address 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00364533