Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: Cebranopadol (GRT6005) Low-Dose Range
* Drug: Cebranopadol (GRT6005) High-Dose Range
* Drug: Placebo
* Drug: Oxycodone CR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cebranopadol (GRT6005) Low-Dose Range<br>Once daily GRT6005, flexible dosing 200, 300 or 400 micrograms, and once daily Placebo; oral administration for 15 weeks | Drug: Cebranopadol (GRT6005) Low-Dose Range<br>* Capsules<br>Drug: Placebo<br>* Capsules that did not contain active substance but appeared identical to the cebranopadol and oxycodone CR capsules<br>|
| Experimental: Cebranopadol (GRT6005) High-Dose Range<br>Once daily GRT6005, flexible dosing 400, 600 or 800 micrograms, and once daily Placebo; oral administration for 15 weeks | Drug: Cebranopadol (GRT6005) High-Dose Range<br>* Capsules<br>Drug: Placebo<br>* Capsules that did not contain active substance but appeared identical to the cebranopadol and oxycodone CR capsules<br>|
| Placebo Comparator: Placebo<br>Twice daily Placebo, oral administration for 15 weeks | Drug: Placebo<br>* Capsules that did not contain active substance but appeared identical to the cebranopadol and oxycodone CR capsules<br>|
| Active Comparator: Oxycodone CR<br>Twice daily Oxycodone CR, flexible dosing 10, 20, 30, 40 or 50 milligrams; oral administration for 15 weeks | Drug: Oxycodone CR<br>* Capsules containing oxycodone CR 10 or 20 milligrams<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the weekly average of the daily average pain rating |  | Baseline to end of treatment (Week 15) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Knee, Pain, Chronic, OA, Arthritis