The purpose of this study is to evaluate the safety and efficacy of GRT6005 compared to placebo in patients with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. This study includes a maximum 21 day Screening Period followed by a 15-week Double-blind Treatment Period and a 4-7 day Safety Follow-up period. Patients who are eligible for the Double-blind Treatment Period will be randomized to one of following treatment groups: GRT6005 high-dose range (400, 600 or 800 mcg), GRT6005 low-dose range (200, 300 or 400 mcg), oxycodone controlled release (CR) dose range (10, 20, 30, 40 or 50 mg) or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
619
Capsules
Capsules
Capsules that did not contain active substance but appeared identical to the cebranopadol and oxycodone CR capsules
Capsules containing oxycodone CR 10 or 20 milligrams
Site 051
Birmingham, Alabama, United States
Site 022
Birmingham, Alabama, United States
Site 031
Huntsville, Alabama, United States
Site 005
Phoenix, Arizona, United States
Site 018
Phoenix, Arizona, United States
Site 070
Phoenix, Arizona, United States
Change from baseline in the weekly average of the daily average pain rating
Time frame: Baseline to end of treatment (Week 15)
Change from baseline in the physical function subscale of the Western Ontario and McMaster University Index of Osteoarthritis Questionnaire (WOMAC)
Time frame: Baseline to end of treatment (Week 15)
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Site 028
Tucson, Arizona, United States
Site 081
Chino, California, United States
Site 030
El Cajon, California, United States
Site 039
Fair Oaks, California, United States
...and 73 more locations