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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00486811
• Date of registration: 14/06/2007
• Primary sponsor: Grünenthal GmbH
• Public 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
• Scientific 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.
• Date of first enrolment: June 2007
• Target sample size: 990
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00486811
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Austria, Croatia, Czech Republic, France, Germany, Hungary, Italy, Latvia, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, United Kingdom

Contacts

• Name: Alain Serrie, Dr.
• Affiliation: C.E.T.D Hôpital Lariboisière, Paris, France

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Knee Osteoarthritis

Pain

Intervention(s)

Drug: Matching Placebo (twice daily)

Drug: Oxycodone CR (20 to 50 mg twice daily)

Drug: Tapentadol ER (100 to 250 mg twice daily)

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

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

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

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

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

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

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

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]

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

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

Secondary ID(s)

2006-005783-67

335862

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

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