A Randomized, Double-Blind, Placebo- and Active Controlled Study to Evaluate the Safety and Efficacy of GRT6005 in Patients With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Tris Pharma, Inc.
- Enrollment
- 619
- Locations
- 83
- Primary Endpoint
- Change from baseline in the weekly average of the daily average pain rating
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cebranopadol (GRT6005) Low-Dose Range
Once daily GRT6005, flexible dosing 200, 300 or 400 micrograms, and once daily Placebo; oral administration for 15 weeks
Intervention: Cebranopadol (GRT6005) Low-Dose Range (Drug)
Cebranopadol (GRT6005) Low-Dose Range
Once daily GRT6005, flexible dosing 200, 300 or 400 micrograms, and once daily Placebo; oral administration for 15 weeks
Intervention: Placebo (Drug)
Cebranopadol (GRT6005) High-Dose Range
Once daily GRT6005, flexible dosing 400, 600 or 800 micrograms, and once daily Placebo; oral administration for 15 weeks
Intervention: Cebranopadol (GRT6005) High-Dose Range (Drug)
Cebranopadol (GRT6005) High-Dose Range
Once daily GRT6005, flexible dosing 400, 600 or 800 micrograms, and once daily Placebo; oral administration for 15 weeks
Intervention: Placebo (Drug)
Placebo
Twice daily Placebo, oral administration for 15 weeks
Intervention: Placebo (Drug)
Oxycodone CR
Twice daily Oxycodone CR, flexible dosing 10, 20, 30, 40 or 50 milligrams; oral administration for 15 weeks
Intervention: Oxycodone CR (Drug)
Outcomes
Primary Outcomes
Change from baseline in the weekly average of the daily average pain rating
Time Frame: Baseline to end of treatment (Week 15)
Secondary Outcomes
- Change from baseline in the physical function subscale of the Western Ontario and McMaster University Index of Osteoarthritis Questionnaire (WOMAC)(Baseline to end of treatment (Week 15))