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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

Primary Purpose

Pain, Knee Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tapentadol ER (100 to 250 mg twice daily)
Matching Placebo (twice daily)
Oxycodone CR (20 to 50 mg twice daily)
Sponsored by
Grünenthal GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Osteoarthritis, Knee, Pain Assessment, CG5503 PR, Centrally acting analgesic, Placebo, Oxycodone, Chronic Pain due to knee Osteoarthritis, Tapentadol

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Site 043005
  • Site 043006
  • Site 043002
  • Site 043001
  • Site 043004
  • Site 043003
  • Site 385003
  • Site 385001
  • Site 385004
  • Seite 385005
  • Site 385002
  • Site 049002
  • Site 049008
  • Site 049010
  • Site 049003
  • Site 049004
  • Site 049007
  • Site 049001
  • Site 049005
  • Site 049009
  • Site 049006
  • Site 036003
  • Site 036005
  • Site 036006
  • Site 036009
  • Site 036008
  • Site 036004
  • Site 036007
  • Site 036002
  • Site 039002
  • Site 039003
  • Site 039004
  • Site 039001
  • Site 371002
  • Site 371004
  • Site 371005
  • Site 031008
  • Site 031003
  • Site 031006
  • Site 031004
  • Site 031007
  • Site 048007
  • Site 048006
  • Site 048005
  • Site 048004
  • Site 048001
  • Site 048008
  • Site 048003
  • Site 048010
  • Site 048009
  • Site 048002
  • Site 048011
  • Site 351001
  • Site 351003
  • Sites 351008
  • Site 351005
  • Site 351004
  • Site 351009
  • Site 351002
  • Site 040001
  • Site 040002
  • Site 040005
  • Site 040006
  • Site 040007
  • Site 040008
  • Site 040009
  • Site 040011
  • Site 040010
  • Site 040004
  • Site 421005
  • Site 421001
  • Site 421003
  • Site 421004
  • Site 421002
  • Site 034002
  • Site 034009
  • Site 034005
  • Site 034007
  • Site 034015
  • Site 034008
  • Site 034003
  • Site 034013
  • Site 034016
  • Site 034001
  • Site 034012
  • Site 034004
  • Site 044012
  • Site 044004
  • Site 044009
  • Site 044013
  • Site 044002
  • Site 044018
  • Site 044005
  • Site 044008
  • Site 044001
  • Site 044006
  • Site 044011
  • Site 044016
  • Site 044003
  • Site 044007

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Matching Placebo (twice daily)

Tapentadol ER (100 to 250 mg twice daily)

Oxycodone CR (20 to 50 mg twice daily)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
The twice daily pain assessments were averaged. The participants were to indicate their pain on an 11-point Numerical 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 intensity.
Patient Global Impression of Change
In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.
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 Western Ontario McMaster Questionnaire (WOMAC) Global Score: WOMAC is measured with a Likert ordinal scale (the participant gives one of 5 possible answers) from 0 to 4. Higher scores indicate that a symptom is bothersome and physically disabling.
Time to Treatment Discontinuation Due to Lack of Efficacy
The median time to treatment discontinuation due to lack of efficacy from baseline to endpoint.
Change in the Health Survey Scores Form (SF-36)
The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state.
EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time
The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead. The positive values indicate that during the study the health status improved.
Sleep Questionnaire: Change From Baseline in Sleep Latency Time in Hours to the Last Week of the Maintenance Period.
The Sleep Questionnaire addressed the following question: "How long after bedtime/lights out did you fall asleep last night(hours)?". The mean change from baseline to 12 weeks was studied. Decrease in time, measured in hours, indicates an improvement.
Sleep Questionnaire: Amount of Time Slept in Hours
The Sleep Questionnaire addressed the following question: "How long did you sleep last night?". The mean change for the number of hours slept during the night before from baseline to 12 weeks was studied.
Sleep Questionnaire: Number of Awakenings During Sleep
The Sleep Questionnaire addressed the following question: "How many times did you wake up during the night?". Sleep was assessed by the subject once a week during the entire double-blind treatment period. Reported are the baseline and end of maintenance period. Generally the less the number of awakenings the better the sleep.
Number of Participants Reporting a Category From the Quality of Sleep (Sleep Questionnaire)
The Sleep Questionnaire addressed the following question: "Please rate the overall quality of your sleep last night?" The quality of sleep at baseline and prior to completion of treatment are reported. The participant can choose one of the following options: Excellent, good, fair and poor.
Patient Assessment of Constipation Symptoms (PAC-SYM) Over Time
The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assesses the severity of symptoms of constipation. Participants are asked "How severe have each of these symptoms been in the last two weeks?" e.g. "Pain in your stomach". There are 3 subscales: 4 questions on Abdominal symptoms, 3 on rectal symptoms and 5 on stool symptoms. Responses are rated on a 5-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). If the changes in the overall or subscale scores are positive then there is a worsening in symptoms associated with constipation.

Full Information

First Posted
June 14, 2007
Last Updated
October 7, 2019
Sponsor
Grünenthal GmbH
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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1. Study Identification

Unique Protocol Identification Number
NCT00486811
Brief Title
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
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grünenthal GmbH
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a randomized (study medication assigned to patients by chance), double-blind (neither patient nor investigator knows which patient gets which study medication, i.e. CG5503, placebo, oxycodone), placebo and active control study. The primary objective is to evaluate the efficacy and safety of orally administered tapentadol (CG5503) prolonged-release (PR) at doses of 100-250 mg (base) twice daily in patients with moderate to severe chronic pain from osteoarthritis (OA) of the knee. The study will consist of five periods: screening (to assess eligibility), washout (3-7 days with determination of a baseline pain intensity), titration (of dose over 3 weeks to the optimal individual level), maintenance (investigational drug intake for 12 weeks with adjustments allowed), and follow-up (2 weeks after end of treatment). The study hypothesis is that the study drug will be more effective than placebo in reducing patients' pain intensity. The secondary objectives include the collection of pharmacokinetic (related to how the body absorbs, distributes, changes and excretes the drug) information for dose verification. The efficacy objectives will be assessed by comparing the baseline pain level to the pain level during the maintenance period. This will be done by looking at the patients' pain diary information (electronic diaries).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Knee Osteoarthritis
Keywords
Osteoarthritis, Knee, Pain Assessment, CG5503 PR, Centrally acting analgesic, Placebo, Oxycodone, Chronic Pain due to knee Osteoarthritis, Tapentadol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
990 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Matching Placebo (twice daily)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Tapentadol ER (100 to 250 mg twice daily)
Arm Type
Experimental
Arm Description
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.
Arm Title
Oxycodone CR (20 to 50 mg twice daily)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tapentadol ER (100 to 250 mg twice daily)
Intervention Description
50, 100, 150, 200, 250 mg twice a day (BID) during 15 weeks (3 weeks titration and 12 weeks maintenance)
Intervention Type
Drug
Intervention Name(s)
Matching Placebo (twice daily)
Intervention Description
Matching Placebo during 15 weeks (3 weeks titration and 12 weeks maintenance)
Intervention Type
Drug
Intervention Name(s)
Oxycodone CR (20 to 50 mg twice daily)
Intervention Description
10, 20, 30, 40, 50 mg twice a day (BID) during 15 weeks (3 weeks titration and 12 weeks maintenance)
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
Change from baseline over the 12 week Maintenance Period
Secondary Outcome Measure Information:
Title
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.
Description
The twice daily pain assessments were averaged. The participants were to indicate their pain on an 11-point Numerical 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 intensity.
Time Frame
Change from Baseline to Week 12 of the Maintenance Period
Title
Patient Global Impression of Change
Description
In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.
Time Frame
Baseline; End of 12 week maintenance period
Title
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
Description
Change from baseline to week 12 of Western Ontario McMaster Questionnaire (WOMAC) Global Score: WOMAC is measured with a Likert ordinal scale (the participant gives one of 5 possible answers) from 0 to 4. Higher scores indicate that a symptom is bothersome and physically disabling.
Time Frame
Change from baseline to week 12 of the maintenance period
Title
Time to Treatment Discontinuation Due to Lack of Efficacy
Description
The median time to treatment discontinuation due to lack of efficacy from baseline to endpoint.
Time Frame
Baseline to week 12 of the maintenance period
Title
Change in the Health Survey Scores Form (SF-36)
Description
The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state.
Time Frame
Change From Baseline to Week 12 of the Maintenance Period
Title
EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time
Description
The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead. The positive values indicate that during the study the health status improved.
Time Frame
Comparison of Baseline to Week 12 of the Maintenance Period
Title
Sleep Questionnaire: Change From Baseline in Sleep Latency Time in Hours to the Last Week of the Maintenance Period.
Description
The Sleep Questionnaire addressed the following question: "How long after bedtime/lights out did you fall asleep last night(hours)?". The mean change from baseline to 12 weeks was studied. Decrease in time, measured in hours, indicates an improvement.
Time Frame
Week 12 of the maintenance period compared to baseline
Title
Sleep Questionnaire: Amount of Time Slept in Hours
Description
The Sleep Questionnaire addressed the following question: "How long did you sleep last night?". The mean change for the number of hours slept during the night before from baseline to 12 weeks was studied.
Time Frame
Baseline to Week 12 of the maintenance period
Title
Sleep Questionnaire: Number of Awakenings During Sleep
Description
The Sleep Questionnaire addressed the following question: "How many times did you wake up during the night?". Sleep was assessed by the subject once a week during the entire double-blind treatment period. Reported are the baseline and end of maintenance period. Generally the less the number of awakenings the better the sleep.
Time Frame
Week 12 of the maintenance period compared with baseline
Title
Number of Participants Reporting a Category From the Quality of Sleep (Sleep Questionnaire)
Description
The Sleep Questionnaire addressed the following question: "Please rate the overall quality of your sleep last night?" The quality of sleep at baseline and prior to completion of treatment are reported. The participant can choose one of the following options: Excellent, good, fair and poor.
Time Frame
Week 12 of the maintenance period compared to baseline
Title
Patient Assessment of Constipation Symptoms (PAC-SYM) Over Time
Description
The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assesses the severity of symptoms of constipation. Participants are asked "How severe have each of these symptoms been in the last two weeks?" e.g. "Pain in your stomach". There are 3 subscales: 4 questions on Abdominal symptoms, 3 on rectal symptoms and 5 on stool symptoms. Responses are rated on a 5-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). If the changes in the overall or subscale scores are positive then there is a worsening in symptoms associated with constipation.
Time Frame
Change from Baseline to Week 12 of the Maintenance Period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Serrie, Dr.
Organizational Affiliation
C.E.T.D Hôpital Lariboisière, Paris, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site 043005
City
Innsbruck
Country
Austria
Facility Name
Site 043006
City
Mitterdorf
Country
Austria
Facility Name
Site 043002
City
Salzburg
Country
Austria
Facility Name
Site 043001
City
Vienna
Country
Austria
Facility Name
Site 043004
City
Vienna
Country
Austria
Facility Name
Site 043003
City
Wiener Neustadt
Country
Austria
Facility Name
Site 385003
City
Karlovac
Country
Croatia
Facility Name
Site 385001
City
Osijek
Country
Croatia
Facility Name
Site 385004
City
Sisak
Country
Croatia
Facility Name
Seite 385005
City
Zagreb
Country
Croatia
Facility Name
Site 385002
City
Zagreb
Country
Croatia
Facility Name
Site 049002
City
Berlin
Country
Germany
Facility Name
Site 049008
City
Berlin
Country
Germany
Facility Name
Site 049010
City
Berlin
Country
Germany
Facility Name
Site 049003
City
Dresden
Country
Germany
Facility Name
Site 049004
City
Frankfurt
Country
Germany
Facility Name
Site 049007
City
Hamburg
Country
Germany
Facility Name
Site 049001
City
Leipzig
Country
Germany
Facility Name
Site 049005
City
Magdeburg
Country
Germany
Facility Name
Site 049009
City
Schwerin
Country
Germany
Facility Name
Site 049006
City
Wiesbaden
Country
Germany
Facility Name
Site 036003
City
Budapest
Country
Hungary
Facility Name
Site 036005
City
Budapest
Country
Hungary
Facility Name
Site 036006
City
Budapest
Country
Hungary
Facility Name
Site 036009
City
Budapest
Country
Hungary
Facility Name
Site 036008
City
Debrecen
Country
Hungary
Facility Name
Site 036004
City
Kecskemet
Country
Hungary
Facility Name
Site 036007
City
Kecskemét
Country
Hungary
Facility Name
Site 036002
City
Visegrad
Country
Hungary
Facility Name
Site 039002
City
Chieti
Country
Italy
Facility Name
Site 039003
City
Milano
Country
Italy
Facility Name
Site 039004
City
Pavia
Country
Italy
Facility Name
Site 039001
City
Perugia
Country
Italy
Facility Name
Site 371002
City
Bauska
Country
Latvia
Facility Name
Site 371004
City
Riga
Country
Latvia
Facility Name
Site 371005
City
Riga
Country
Latvia
Facility Name
Site 031008
City
Eindhoven
Country
Netherlands
Facility Name
Site 031003
City
Losser
Country
Netherlands
Facility Name
Site 031006
City
Oude Pekela
Country
Netherlands
Facility Name
Site 031004
City
s'Hertogenbosch
Country
Netherlands
Facility Name
Site 031007
City
Spijkenisse
Country
Netherlands
Facility Name
Site 048007
City
Bielsko-Biala
Country
Poland
Facility Name
Site 048006
City
Katowice
Country
Poland
Facility Name
Site 048005
City
Konskie
Country
Poland
Facility Name
Site 048004
City
Krakow
Country
Poland
Facility Name
Site 048001
City
Lublin
Country
Poland
Facility Name
Site 048008
City
Mielec
Country
Poland
Facility Name
Site 048003
City
Piekary Slaskie
Country
Poland
Facility Name
Site 048010
City
Rzeszow
Country
Poland
Facility Name
Site 048009
City
Warszawa
Country
Poland
Facility Name
Site 048002
City
Wroclaw
Country
Poland
Facility Name
Site 048011
City
Wroclaw
Country
Poland
Facility Name
Site 351001
City
Coimbra
Country
Portugal
Facility Name
Site 351003
City
Faro
Country
Portugal
Facility Name
Sites 351008
City
Funchal
Country
Portugal
Facility Name
Site 351005
City
Guimaraes
Country
Portugal
Facility Name
Site 351004
City
Lisboa
Country
Portugal
Facility Name
Site 351009
City
Lisboa
Country
Portugal
Facility Name
Site 351002
City
Ponta Delgada
Country
Portugal
Facility Name
Site 040001
City
Bucharest
Country
Romania
Facility Name
Site 040002
City
Bucharest
Country
Romania
Facility Name
Site 040005
City
Bucharest
Country
Romania
Facility Name
Site 040006
City
Bucharest
Country
Romania
Facility Name
Site 040007
City
Bucharest
Country
Romania
Facility Name
Site 040008
City
Bucharest
Country
Romania
Facility Name
Site 040009
City
Bucharest
Country
Romania
Facility Name
Site 040011
City
Bucharest
Country
Romania
Facility Name
Site 040010
City
Craiova
Country
Romania
Facility Name
Site 040004
City
Câmpulung
Country
Romania
Facility Name
Site 421005
City
Banska Bystrica
Country
Slovakia
Facility Name
Site 421001
City
Kosice
Country
Slovakia
Facility Name
Site 421003
City
Poprad
Country
Slovakia
Facility Name
Site 421004
City
Presov
Country
Slovakia
Facility Name
Site 421002
City
Rimavska Sobota
Country
Slovakia
Facility Name
Site 034002
City
Alicante
Country
Spain
Facility Name
Site 034009
City
Benidorm
Country
Spain
Facility Name
Site 034005
City
L'Hospitalet de Llobregat
Country
Spain
Facility Name
Site 034007
City
La roca del Valles
Country
Spain
Facility Name
Site 034015
City
Malaga
Country
Spain
Facility Name
Site 034008
City
Mostoles
Country
Spain
Facility Name
Site 034003
City
Oviedo
Country
Spain
Facility Name
Site 034013
City
Oviedo
Country
Spain
Facility Name
Site 034016
City
Sevilla
Country
Spain
Facility Name
Site 034001
City
Torrelavega
Country
Spain
Facility Name
Site 034012
City
Valencia
Country
Spain
Facility Name
Site 034004
City
Vic
Country
Spain
Facility Name
Site 044012
City
Birmingham
Country
United Kingdom
Facility Name
Site 044004
City
Blackpool
Country
United Kingdom
Facility Name
Site 044009
City
Bradford
Country
United Kingdom
Facility Name
Site 044013
City
Cardiff
Country
United Kingdom
Facility Name
Site 044002
City
Chesterfield
Country
United Kingdom
Facility Name
Site 044018
City
Chorley
Country
United Kingdom
Facility Name
Site 044005
City
Ecclesfield
Country
United Kingdom
Facility Name
Site 044008
City
Falkirk
Country
United Kingdom
Facility Name
Site 044001
City
Kenton
Country
United Kingdom
Facility Name
Site 044006
City
London
Country
United Kingdom
Facility Name
Site 044011
City
London
Country
United Kingdom
Facility Name
Site 044016
City
Reading
Country
United Kingdom
Facility Name
Site 044003
City
Solihull
Country
United Kingdom
Facility Name
Site 044007
City
Woolpit
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24985410
Citation
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.
Results Reference
derived
PubMed Identifier
24916058
Citation
Biondi 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.
Results Reference
derived
PubMed Identifier
24353047
Citation
Etropolski 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.
Results Reference
derived
PubMed Identifier
23709304
Citation
Merchant 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.
Results Reference
derived
PubMed Identifier
23340531
Citation
Afilalo M, Morlion B. Efficacy of tapentadol ER for managing moderate to severe chronic pain. Pain Physician. 2013 Jan;16(1):27-40.
Results Reference
derived

Learn more about this trial

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

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