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
A Randomized Double-blind, Placebo- and Active-control, Parallel-arm, Phase III Trial With Controlled Adjustment of Dose 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.
2 other identifiers
interventional
990
13 countries
100
Brief Summary
The purpose of this study is to evaluate whether tapentadol (CG5503) prolonged-release (PR) tablets at doses of 100-250 mg twice daily provide a better pain relief in patients with moderate to severe chronic pain due to osteoarthritis of the knee than a placebo (a medication without active substance). In addition the tolerability of CG5503 PR will be assessed. One third of the patients will receive CG5503 and one third will receive placebo. For further comparison one third of the patients will receive oxycodone controlled release (CR) at doses of 20-50 mg twice daily which is an active approved pain medication. Please note that tapentadol ER (Extended Release) and tapentadol PR (Prolonged Release) are identical and used interchangeably. This is due to United States of America and European naming conventions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pain
Started Jun 2007
100 active sites
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
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 14, 2007
CompletedFirst Posted
Study publicly available on registry
June 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
January 11, 2011
CompletedOctober 18, 2019
October 1, 2019
1.1 years
June 14, 2007
October 25, 2010
October 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
For this twice daily pain assessment, the participants were required to indicate the level of pain experienced over the previous 12 hours on an 11-point Numeric Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The lower the value the less pain in the treatment group. Negative values indicate a reduction in pain.
Change from baseline over the 12 week Maintenance Period
Secondary Outcomes (11)
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.
Change from Baseline to Week 12 of the Maintenance Period
Patient Global Impression of Change
Baseline; End of 12 week maintenance period
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
Change from baseline to week 12 of the maintenance period
Time to Treatment Discontinuation Due to Lack of Efficacy
Baseline to week 12 of the maintenance period
Change in the Health Survey Scores Form (SF-36)
Change From Baseline to Week 12 of the Maintenance Period
- +6 more secondary outcomes
Study Arms (3)
Matching Placebo (twice daily)
PLACEBO COMPARATORThe 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 (100 to 250 mg twice daily)
EXPERIMENTALThe 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.
Oxycodone CR (20 to 50 mg twice daily)
ACTIVE COMPARATORThe 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.
Interventions
50, 100, 150, 200, 250 mg twice a day (BID) during 15 weeks (3 weeks titration and 12 weeks maintenance)
Matching Placebo during 15 weeks (3 weeks titration and 12 weeks maintenance)
10, 20, 30, 40, 50 mg twice a day (BID) during 15 weeks (3 weeks titration and 12 weeks maintenance)
Eligibility Criteria
You may qualify if:
- Patients diagnosed with osteoarthritis of the knee based on the American College of Rheumatology (ACR) criteria and functional capacity class of I- III;
- Patients taking analgesic medications for at least 3 months prior to screening and dissatisfied with their current therapy;
- Patients requiring opioid treatment must be taking daily doses of opioid- based analgesic, equivalent to \<160 mg of oral morphine;
- Baseline score of \>=5 on an 11-point numeric rating scale, calculated as the average pain intensity during the last 3 days prior to randomization.
You may not qualify if:
- History of alcohol and/or drug abuse in Investigator's judgment;
- Chronic hepatitis B or C, or HIV, presence of active hepatitis B or C within the past 3 months;
- Life-long history of seizure disorder or epilepsy;
- History of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated;
- Uncontrolled hypertension;
- Patients with severely impaired renal function;
- Patients with moderate to severely impaired hepatic function or with laboratory values reflecting inadequate hepatic function,
- Treatment with neuroleptics, monoamine oxidase inhibitors, serotonin norepinephrine reuptake inhibitors (SNRI), tricyclic antidepressants, anticonvulsants, or anti-parkinsonian drugs, treatment with any other analgesic therapy than investigational medication or rescue medication during the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (100)
Site 043005
Innsbruck, Austria
Site 043006
Mitterdorf, Austria
Site 043002
Salzburg, Austria
Site 043001
Vienna, Austria
Site 043004
Vienna, Austria
Site 043003
Wiener Neustadt, Austria
Site 385003
Karlovac, Croatia
Site 385001
Osijek, Croatia
Site 385004
Sisak, Croatia
Seite 385005
Zagreb, Croatia
Site 385002
Zagreb, Croatia
Site 049002
Berlin, Germany
Site 049008
Berlin, Germany
Site 049010
Berlin, Germany
Site 049003
Dresden, Germany
Site 049004
Frankfurt, Germany
Site 049007
Hamburg, Germany
Site 049001
Leipzig, Germany
Site 049005
Magdeburg, Germany
Site 049009
Schwerin, Germany
Site 049006
Wiesbaden, Germany
Site 036003
Budapest, Hungary
Site 036005
Budapest, Hungary
Site 036006
Budapest, Hungary
Site 036009
Budapest, Hungary
Site 036008
Debrecen, Hungary
Site 036004
Kecskemét, Hungary
Site 036007
Kecskemét, Hungary
Site 036002
Visegrád, Hungary
Site 039002
Chieti, Italy
Site 039003
Milan, Italy
Site 039004
Pavia, Italy
Site 039001
Perugia, Italy
Site 371002
Bauska, Latvia
Site 371004
Riga, Latvia
Site 371005
Riga, Latvia
Site 031008
Eindhoven, Netherlands
Site 031003
Losser, Netherlands
Site 031006
Oude Pekela, Netherlands
Site 031004
s'Hertogenbosch, Netherlands
Site 031007
Spijkenisse, Netherlands
Site 048007
Bielsko-Biala, Poland
Site 048005
Gmina Końskie, Poland
Site 048006
Katowice, Poland
Site 048004
Krakow, Poland
Site 048001
Lublin, Poland
Site 048008
Mielec, Poland
Site 048003
Piekary Śląskie, Poland
Site 048010
Rzeszów, Poland
Site 048009
Warsaw, Poland
Site 048002
Wroclaw, Poland
Site 048011
Wroclaw, Poland
Site 351001
Coimbra, Portugal
Site 351003
Faro, Portugal
Sites 351008
Funchal, Portugal
Site 351005
Guimarães, Portugal
Site 351004
Lisbon, Portugal
Site 351009
Lisbon, Portugal
Site 351002
Ponta Delgada, Portugal
Site 040001
Bucharest, Romania
Site 040002
Bucharest, Romania
Site 040005
Bucharest, Romania
Site 040006
Bucharest, Romania
Site 040007
Bucharest, Romania
Site 040008
Bucharest, Romania
Site 040009
Bucharest, Romania
Site 040011
Bucharest, Romania
Site 040004
Campulung Muscel, Romania
Site 040010
Craiova, Romania
Site 421005
Banská Bystrica, Slovakia
Site 421001
Košice, Slovakia
Site 421003
Poprad, Slovakia
Site 421004
Prešov, Slovakia
Site 421002
Rimavská Sobota, Slovakia
Site 034002
Alicante, Spain
Site 034009
Benidorm, Spain
Site 034005
L'Hospitalet de Llobregat, Spain
Site 034007
La Roca del Vallès, Spain
Site 034015
Málaga, Spain
Site 034008
Móstoles, Spain
Site 034003
Oviedo, Spain
Site 034013
Oviedo, Spain
Site 034016
Seville, Spain
Site 034001
Torrelavega, Spain
Site 034012
Valencia, Spain
Site 034004
Vic, Spain
Site 044012
Birmingham, United Kingdom
Site 044004
Blackpool, United Kingdom
Site 044009
Bradford, United Kingdom
Site 044013
Cardiff, United Kingdom
Site 044002
Chesterfield, United Kingdom
Site 044018
Chorley, United Kingdom
Site 044005
Ecclesfield, United Kingdom
Site 044008
Falkirk, United Kingdom
Site 044001
Kenton, United Kingdom
Site 044006
London, United Kingdom
Site 044011
London, United Kingdom
Site 044016
Reading, United Kingdom
Site 044003
Solihull, United Kingdom
Site 044007
Woolpit, United Kingdom
Related Publications (5)
Etropolski M, Kuperwasser B, Flugel M, Haufel T, Lange B, Rauschkolb C, Laschewski F. Safety and tolerability of tapentadol extended release in moderate to severe chronic osteoarthritis or low back pain management: pooled analysis of randomized controlled trials. Adv Ther. 2014 Jun;31(6):604-20. doi: 10.1007/s12325-014-0128-6. Epub 2014 Jul 2.
PMID: 24985410DERIVEDBiondi DM, Xiang J, Etropolski M, Moskovitz B. Evaluation of blood pressure and heart rate in patients with hypertension who received tapentadol extended release for chronic pain: a post hoc, pooled data analysis. Clin Drug Investig. 2014 Aug;34(8):565-76. doi: 10.1007/s40261-014-0209-y.
PMID: 24916058DERIVEDEtropolski M, Lange B, Goldberg J, Steup A, Rauschkolb C. A pooled analysis of patient-specific factors and efficacy and tolerability of tapentadol extended release treatment for moderate to severe chronic pain. J Opioid Manag. 2013 Sep-Oct;9(5):343-56. doi: 10.5055/jom.2013.0177.
PMID: 24353047DERIVEDMerchant S, Provenzano D, Mody S, Ho KF, Etropolski M. Composite measure to assess efficacy/gastrointestinal tolerability of tapentadol ER versus oxycodone CR for chronic pain: pooled analysis of randomized studies. J Opioid Manag. 2013 Jan-Feb;9(1):51-61. doi: 10.5055/jom.2013.0147.
PMID: 23709304DERIVEDAfilalo M, Morlion B. Efficacy of tapentadol ER for managing moderate to severe chronic pain. Pain Physician. 2013 Jan;16(1):27-40.
PMID: 23340531DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Claudia Leinweber
- Organization
- Grünenthal GmbH
Study Officials
- PRINCIPAL INVESTIGATOR
Alain Serrie, Dr.
C.E.T.D Hôpital Lariboisière, Paris, France
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2007
First Posted
June 15, 2007
Study Start
June 1, 2007
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
October 18, 2019
Results First Posted
January 11, 2011
Record last verified: 2019-10