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

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

Hide 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

Show All 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

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Hide Other Adverse Events

Time Frame	All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

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

Other Adverse Events

	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, other (not including serious) adverse events
# participants affected / at risk	52	38	53	43	44
Blood and lymphatic system disorders
Anaemia * ^A # participants affected / at risk	6/77 (7.79%)	3/71 (4.23%)	8/75 (10.67%)	11/67 (16.42%)	7/75 (9.33%)
Gastrointestinal disorders
Constipation * ^A # participants affected / at risk	11/77 (14.29%)	6/71 (8.45%)	10/75 (13.33%)	12/67 (17.91%)	7/75 (9.33%)
Dry Mouth * ^A # participants affected / at risk	1/77 (1.30%)	7/71 (9.86%)	3/75 (4.00%)	3/67 (4.48%)	0/75 (0.00%)
Nausea * ^A # participants affected / at risk	19/77 (24.68%)	5/71 (7.04%)	12/75 (16.00%)	12/67 (17.91%)	11/75 (14.67%)
Vomiting * ^A # participants affected / at risk	5/77 (6.49%)	6/71 (8.45%)	4/75 (5.33%)	10/67 (14.93%)	12/75 (16.00%)
General disorders
Pyrexia * ^A # participants affected / at risk	15/77 (19.48%)	8/71 (11.27%)	13/75 (17.33%)	14/67 (20.90%)	7/75 (9.33%)
Investigations
Body Temperature Increased * ^A # participants affected / at risk	8/77 (10.39%)	7/71 (9.86%)	4/75 (5.33%)	5/67 (7.46%)	7/75 (9.33%)
Musculoskeletal and connective tissue disorders
Muscle Spasms * ^A # participants affected / at risk	2/77 (2.60%)	4/71 (5.63%)	0/75 (0.00%)	1/67 (1.49%)	1/75 (1.33%)
Nervous system disorders
Dizziness * ^A # participants affected / at risk	7/77 (9.09%)	8/71 (11.27%)	16/75 (21.33%)	14/67 (20.90%)	4/75 (5.33%)
Headache * ^A # participants affected / at risk	5/77 (6.49%)	5/71 (7.04%)	2/75 (2.67%)	9/67 (13.43%)	13/75 (17.33%)
Somnolence * ^A # participants affected / at risk	11/77 (14.29%)	10/71 (14.08%)	17/75 (22.67%)	6/67 (8.96%)	1/75 (1.33%)
Psychiatric disorders
Confusional State * ^A # participants affected / at risk	6/77 (7.79%)	4/71 (5.63%)	11/75 (14.67%)	1/67 (1.49%)	0/75 (0.00%)
Hallucination, Visual * ^A # participants affected / at risk	2/77 (2.60%)	5/71 (7.04%)	8/75 (10.67%)	2/67 (2.99%)	2/75 (2.67%)
Insomnia * ^A # participants affected / at risk	1/77 (1.30%)	3/71 (4.23%)	1/75 (1.33%)	3/67 (4.48%)	4/75 (5.33%)
Skin and subcutaneous tissue disorders
Pruritus * ^A # participants affected / at risk	3/77 (3.90%)	2/71 (2.82%)	4/75 (5.33%)	4/67 (5.97%)	0/75 (0.00%)
Vascular disorders
Hypotension * ^A # participants affected / at risk	4/77 (5.19%)	1/71 (1.41%)	5/75 (6.67%)	1/67 (1.49%)	2/75 (2.67%)

*	Indicates events were collected by non-systematic assessment.
^A	Term from vocabulary, MedDRA 10.1

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: A provision provides for 60 day prior review by sponsor extendable by 60 days to file a patent application and prior written consent of sponsor for disclosure of confidential information, if any.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Sponsor terminated study, sample size not reached. The protocol section describes 4 study arms defining the treatment groups in the study design. The participant flow module describes the 5 treatment groups analyzed for the primary endpoint

Results Point of Contact:

Name/Title: Senior Director, Clinical Leader
Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
phone: 609-730-6780

No publications provided

Responsible Party:	Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ( Senior Director, Clinical Leader )
Study ID Numbers:	CR011221, R331333PAI3001, KF5503/31
Study First Received:	August 11, 2006
Results First Received:	December 19, 2008
Last Updated:	September 25, 2009
ClinicalTrials.gov Identifier:	NCT00364533 History of Changes
Health Authority:	United States: Food and Drug Administration