Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain
Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
About this trial
This is an interventional treatment trial for Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee focused on measuring Osteoarthritis, Knee, Pain, Chronic, OA, Arthritis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of osteoarthritis (OA) of the knee
- OA knee pain present for at least 3 months
- OA knee pain is the predominant (ie, most painful) pain condition
- Patients require medication on at least 4 of 7 days per week to treat OA knee pain for at least 1 month.
- Dissatisfaction with current OA knee pain treatment and willingness to stop taking all pain medications except for the study drug and allowed rescue medication
- Average daily pain rating of at least 5 on a 0 to 10 point numerical rating scale during the 1 week prior to randomization
- Female patients either postmenopausal, surgically sterile or practicing a medically acceptable method of contraception
- Male patients either status post-bilateral vasectomy or using barrier contraception
Exclusion Criteria:
- Knee pain due to a disorder other than OA
- Other pain that can confound the assessment of, or contribute to, pain at the reference knee
- Surgery at the reference knee within 6 months of Screening or a history of joint replacement surgery at the reference knee
- Trauma to the reference knee within 6 months of Screening with active symptoms
- Steroid injections in the reference knee within 3 months of Screening
- Hyaluronic acid injections in the reference knee within 6 months of Screening
- Body Mass Index > 40 kg/m2
- Patient with any protocol-excluded or clinically significant medical, surgical, or medication history that would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Placebo Comparator
Active Comparator
Cebranopadol (GRT6005) Low-Dose Range
Cebranopadol (GRT6005) High-Dose Range
Placebo
Oxycodone CR
Once daily GRT6005, flexible dosing 200, 300 or 400 micrograms, and once daily Placebo; oral administration for 15 weeks
Once daily GRT6005, flexible dosing 400, 600 or 800 micrograms, and once daily Placebo; oral administration for 15 weeks
Twice daily Placebo, oral administration for 15 weeks
Twice daily Oxycodone CR, flexible dosing 10, 20, 30, 40 or 50 milligrams; oral administration for 15 weeks