A Phase III Trial to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administrated CG5503 Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain due to osteoarthritis of the knee, in comparison with placebo and Oxycodone Controlled Release (CR).

Official Title

A Randomised Double-Blind, Placebo- and Active-Control, Parallel-Arm, Phase III Trial With Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of CG5503 Extended-Release (ER) in Patients With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

Conditions

• Osteoarthritis, Knee
• Pain

Study Type

Interventional

Study Design

Treatment, Randomised, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures: 

• Change from baseline of the average pain intensity over the last week of the Maintenance period at Week 12 or over the entire 12-week Maintenance period, depending on country requirements.

Secondary Outcome Measures:

• Incidence rates of treatment-emergent adverse events. Changes from baseline of the Western Ontario MacMaster Questionnaire (WOMAC), Sleep Questionnaire (SQ), 11-point NRS , and others, for a maximum timeframe of 20 weeks.

Study Start

January 2007

Eligibility & Criteria

Eligibility

• Ages Eligible for Study: 40 years and older
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: No

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/or 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 numerical rater scale, calculated as the average pain intensity during the last 3 days prior to randomisation. Patients must meet all 4 assessments

Exclusion Criteria:

• History of alcohol and/or drug abuse in Investigator’s judgement
• History of significant liver insufficiency
• 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

Total Enrolment

942

Contact Details

Location Details

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