A Study to Evaluate the Efficacy and Safety of CG5503 Prolonged Release (PR) in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

This study has been completed.

Sponsor:

Collaborator:

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

Information provided by (Responsible Party):

Grünenthal GmbH

ClinicalTrials.gov Identifier:

NCT00486811

First received: June 14, 2007

Last updated: April 16, 2012

Last verified: April 2012

History of Changes

Results First Received: October 25, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Pain Knee Osteoarthritis
Interventions:	Drug: Tapentadol ER (100 to 250 mg twice daily) Drug: Matching Placebo (twice daily) Drug: Oxycodone CR (20 to 50 mg twice daily)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First participant was enrolled on 04 June 2007 and the last participant out was on 18 July 2008.

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

Placebo Matching

Drug: Matching Placebo (twice daily)

The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions.

Tapentadol ER

Tapentadol ER (100 to 250 mg twice daily) The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.

Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance).

Oxycodone CR

Oxycodone CR (20 to 50 mg twice daily).

The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance).

Participant Flow: Overall Study

	Placebo Matching	Tapentadol ER	Oxycodone CR
STARTED	337	320 ^[1]	333 ^[2]
COMPLETED	215	179	119
NOT COMPLETED	122	141	214
Adverse Event	28	60	135
Lack of Efficacy	34	14	7
Lost to Follow-up	4	6	4
Withdrawal by Subject	33	44	58
Study drug non-compliant	5	6	3
All other	18	11	7

[1]	One participant was not eligible to be dosed.
[2]	Two participants were not eligible to be dosed.

Baseline Characteristics

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Reporting Groups

	Description
Placebo Matching	Drug: Matching Placebo (twice daily) The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions.
Tapentadol ER	Tapentadol ER (100 to 250 mg twice daily) The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance).
Oxycodone CR	Oxycodone CR (20 to 50 mg twice daily). The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance).
Total	Total of all reporting groups

Baseline Measures

	Placebo Matching	Tapentadol ER	Oxycodone CR	Total
Number of Participants [units: participants]	337	319	331	987
Age [units: years] Mean ± Standard Deviation	62.2 ± 9.35	62.4 ± 9.35	61.8 ± 9.09	62.1 ± 9.26
Age, Customized [units: participants]
Between 18 and 65 years	194	194	211	599
>=65 years	143	125	120	388
Gender [units: participants]
Female	257	231	219	707
Male	80	88	112	280
Region of Enrollment [units: participants]
Portugal	8	4	3	15
Slovakia	7	8	9	24
Spain	29	23	25	77
Austria	14	12	15	41
United Kingdom	23	24	28	75
Hungary	36	35	34	105
Poland	11	11	13	35
Romania	107	103	104	314
Croatia	12	9	8	29
Germany	58	60	59	177
Latvia	24	21	24	69
Netherlands	8	9	9	26

Outcome Measures

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1. Primary:

Change From Baseline of the Average Pain Intensity Overall in the 12-week Maintenance Period of the Daily Pain Intensity on an 11-point Numeric Rating Scale (NRS). [ Time Frame: Change from baseline over the 12 week Maintenance Period ]

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2. Secondary:

Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12. [ Time Frame: Change from Baseline to Week 12 of the Maintenance Period ]

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3. Secondary:

Patient Global Impression of Change [ Time Frame: Baseline; End of 12 week maintenance period ]

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4. Secondary:

Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12 [ Time Frame: Change from baseline to week 12 of the maintenance period ]

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5. Secondary:

Time to Treatment Discontinuation Due to Lack of Efficacy [ Time Frame: Baseline to week 12 of the maintenance period ]

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6. Secondary:

Change in the Health Survey Scores Form (SF-36) [ Time Frame: Change From Baseline to Week 12 of the Maintenance Period ]

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7. Secondary:

EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time [ Time Frame: Comparison of Baseline to Week 12 of the Maintenance Period ]

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8. Secondary:

Sleep Questionnaire: Change From Baseline in Sleep Latency Time in Hours to the Last Week of the Maintenance Period. [ Time Frame: Week 12 of the maintenance period compared to baseline ]

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9. Secondary:

Sleep Questionnaire: Amount of Time Slept in Hours [ Time Frame: Baseline to Week 12 of the maintenance period ]

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10. Secondary:

Sleep Questionnaire: Number of Awakenings During Sleep [ Time Frame: Week 12 of the maintenance period compared with baseline ]

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11. Secondary:

Number of Participants Reporting a Category From the Quality of Sleep (Sleep Questionnaire) [ Time Frame: Week 12 of the maintenance period compared to baseline ]

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12. Secondary:

Patient Assessment of Constipation Symptoms (PAC-SYM) Over Time [ Time Frame: Change from Baseline to Week 12 of the Maintenance Period ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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: The Sponsor and the Sponsor's designee reserves the right to review any publication pertaining to the trial at least 30 days before it is submitted for publication. Neither party has the right to prohibit publication unless publication can be shown to affect possible patent rights.

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
No text entered.

Results Point of Contact:

Name/Title: Claudia Leinweber
Organization: Grünenthal GmbH
phone: +49 241 569 2509
e-mail: claudia.leinweber@grunenthal.com

No publications provided by Grünenthal GmbH

Publications automatically indexed to this study:

Afilalo M, Morlion B. Efficacy of tapentadol ER for managing moderate to severe chronic pain. Pain Physician. 2013 Jan;16(1):27-40.

Responsible Party:	Grünenthal GmbH
ClinicalTrials.gov Identifier:	NCT00486811 History of Changes
Other Study ID Numbers:	335862, 2006-005783-67
Study First Received:	June 14, 2007
Results First Received:	October 25, 2010
Last Updated:	April 16, 2012
Health Authority:	Czech Republic: State Institute for Drug Control Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Italy: IRCCS Ospedale Maggiore di Milano Latvia: State Agency of Medicines Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Poland: CEBK (Centralna Ewidencja Badan Klinicznych) Portugal: Board of Hospital Distrital de Faro Portugal: Board of Hospital Do Divino Espirito Santo de Ponta Delgada Portugal: Board of Hospitalda Universidade de Coimbra Portugal: Board of Hospital des. Hospital Senhora da Oliveira Guimaraes Portugal: Board of Hospital Central do Funchal Portugal: Board of Instituto de Reumatologia Lisboa Romania: National Medicines Agency Spain: Agencia Española de Medicamentos y Productos Sanitarios France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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