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

This study has been terminated.

( This decision was made based on the slow recruitment and high discontinuation rates in the study. )

Study NCT00364533 Information provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

First Received: August 11, 2006 Last Updated: September 25, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Conditions:	Arthralgia. Pain Assessment Arthroplasty Replacement, Hip
Interventions:	Drug: Tapentadol IR (CG5503) Drug: Oxycodone HCL IR Drug: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Tapentadol IR Fixed Dose 50 mg	Tapentadol taken by mouth every 4-6 hours for 3 days
Tapentadol IR Fixed Dose 75 mg	Tapentadol taken by mouth every 4-6 hours for 3 days
Tapentadol IR Fixed Dose 100 mg	Tapentadol taken by mouth every 4-6 hours for 3 days
Oxycodone HCL IR Fixed Dose 10 mg	oxycodone 10mg taken by mouth every 4-6 hours for 3 days
Placebo Fixed Dose	Matching placebo taken by mouth every 4-6 hours for 3 days

Participant Flow: Overall Study

	Tapentadol IR Fixed Dose 50 mg	Tapentadol IR Fixed Dose 75 mg	Tapentadol IR Fixed Dose 100 mg	Oxycodone HCL IR Fixed Dose 10 mg	Placebo Fixed Dose
STARTED	77	71	75	67	75
COMPLETED	35	31	30	36	24
NOT COMPLETED	42	40	45	31	51
Adverse Event	8	7	15	5	2
Withdrawal by Subject	4	8	6	6	6
Lack of Efficacy	22	22	21	17	42
Subject discharged from hospital	4	1	2	3	1
Variations in drug compliance	2	1	1	0	0
Non-compliance	1	0	0	0	0
Protocol Violation	1	1	0	0	0

Baseline Characteristics

Reporting Groups

	Description
Tapentadol IR Fixed Dose 50 mg	Tapentadol taken by mouth every 4-6 hours for 3 days
Tapentadol IR Fixed Dose 75 mg	Tapentadol taken by mouth every 4-6 hours for 3 days
Tapentadol IR Fixed Dose 100 mg	Tapentadol taken by mouth every 4-6 hours for 3 days
Oxycodone HCL IR Fixed Dose 10 mg	oxycodone 10mg taken by mouth every 4-6 hours for 3 days
Placebo Fixed Dose	Matching placebo taken by mouth every 4-6 hours for 3 days

Baseline Measures

	Tapentadol IR Fixed Dose 50 mg	Tapentadol IR Fixed Dose 75 mg	Tapentadol IR Fixed Dose 100 mg	Oxycodone HCL IR Fixed Dose 10 mg	Placebo Fixed Dose	Total
Number of Participants [units: participants]	77	71	75	67	75	365
Age [units: years] Mean ± Standard Deviation	62.2 ± 12.20	62.8 ± 9.24	63.3 ± 10.3	61.3 ± 12.39	64.0 ± 11.23	62.7 ± 11.11
Gender [units: participants]
Female	39	32	41	41	44	197
Male	38	39	34	26	31	168

Outcome Measures

1. Primary:

Sum of Pain Intensity Difference Over 48 Hours (SPID48) [ 48 hours ]

Show Outcome Measure 1

2. Secondary:

Time to First Rescue Pain Medication. [ 3 days ]

Show Outcome Measure 2

3. Secondary:

The SPID at 12, 24, and 72 Hours Relative to First Dose. [ 3 days ]

Show Outcome Measure 3