Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain
- Conditions
- Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
- Interventions
- Registration Number
- NCT01709214
- Lead Sponsor
- Tris Pharma, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 619
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cebranopadol (GRT6005) Low-Dose Range Placebo Once daily GRT6005, flexible dosing 200, 300 or 400 micrograms, and once daily Placebo; oral administration for 15 weeks Cebranopadol (GRT6005) High-Dose Range Placebo Once daily GRT6005, flexible dosing 400, 600 or 800 micrograms, and once daily Placebo; oral administration for 15 weeks Placebo Placebo Twice daily Placebo, oral administration for 15 weeks Oxycodone CR Oxycodone CR Twice daily Oxycodone CR, flexible dosing 10, 20, 30, 40 or 50 milligrams; oral administration for 15 weeks Cebranopadol (GRT6005) Low-Dose Range Cebranopadol (GRT6005) Low-Dose Range Once daily GRT6005, flexible dosing 200, 300 or 400 micrograms, and once daily Placebo; oral administration for 15 weeks Cebranopadol (GRT6005) High-Dose Range Cebranopadol (GRT6005) High-Dose Range Once daily GRT6005, flexible dosing 400, 600 or 800 micrograms, and once daily Placebo; oral administration for 15 weeks
- Primary Outcome Measures
Name Time Method Change from baseline in the weekly average of the daily average pain rating Baseline to end of treatment (Week 15)
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (83)
Site 011
🇺🇸Bradenton, Florida, United States
Site 061
🇺🇸Fresno, California, United States
Site 043
🇺🇸Tustin, California, United States
Site 071
🇺🇸Clearwater, Florida, United States
Site 058
🇺🇸Pembroke Pines, Florida, United States
Site 086
🇺🇸Chicago, Illinois, United States
Site 052
🇺🇸Marietta, Georgia, United States
Site 001
🇺🇸Columbus, Ohio, United States
Site 042
🇺🇸Traverse City, Michigan, United States
Site 069
🇺🇸Cleveland, Ohio, United States
Site 038
🇺🇸Dallas, Texas, United States
Site 065
🇺🇸Seattle, Washington, United States
Site 013
🇺🇸Miami, Florida, United States
Site 041
🇺🇸Indianapolis, Indiana, United States
Site 024
🇺🇸Las Vegas, Nevada, United States
Site 079
🇺🇸Cincinnati, Ohio, United States
Site 072
🇺🇸Las Vegas, Nevada, United States
Site 008
🇺🇸Cincinnati, Ohio, United States
Site 070
🇺🇸Phoenix, Arizona, United States
Site 040
🇺🇸San Antonio, Texas, United States
Site 075
🇺🇸Oklahoma City, Oklahoma, United States
Site 022
🇺🇸Birmingham, Alabama, United States
Site 035
🇺🇸Portland, Oregon, United States
Site 018
🇺🇸Phoenix, Arizona, United States
Site 051
🇺🇸Birmingham, Alabama, United States
Site 064
🇺🇸Ogden, Utah, United States
Site 074
🇺🇸Omaha, Nebraska, United States
Site 023
🇺🇸Saint Louis, Missouri, United States
Site 031
🇺🇸Huntsville, Alabama, United States
Site 068
🇺🇸Albany, New York, United States
Site 005
🇺🇸Phoenix, Arizona, United States
Site 030
🇺🇸El Cajon, California, United States
Site 028
🇺🇸Tucson, Arizona, United States
Site 081
🇺🇸Chino, California, United States
Site 039
🇺🇸Fair Oaks, California, United States
Site 080
🇺🇸Roseville, California, United States
Site 084
🇺🇸North Hollywood, California, United States
Site 004
🇺🇸Sacramento, California, United States
Site 044
🇺🇸San Diego, California, United States
Site 010
🇺🇸Walnut Creek, California, United States
Site 027
🇺🇸Westlake Village, California, United States
Site 090
🇺🇸Edgewater, Florida, United States
Site 060
🇺🇸Jacksonville, Florida, United States
Site 015
🇺🇸Jupiter, Florida, United States
Site 003
🇺🇸New Port Richey, Florida, United States
Site 012
🇺🇸Ocala, Florida, United States
Site 032
🇺🇸Orlando, Florida, United States
Site 025
🇺🇸Ormond Beach, Florida, United States
Site 091
🇺🇸Pinellas Park, Florida, United States
Site 007
🇺🇸Sarasota, Florida, United States
Site 033
🇺🇸Perry, Georgia, United States
Site 073
🇺🇸Stockbridge, Georgia, United States
Site 077
🇺🇸Wheaton, Maryland, United States
Site 088
🇺🇸Towson, Maryland, United States
Site 083
🇺🇸New Bedford, Massachusetts, United States
Site 021
🇺🇸North Dartmouth, Massachusetts, United States
Site 016
🇺🇸Bingham Farms, Michigan, United States
Site 087
🇺🇸Grand Island, Nebraska, United States
Site 006
🇺🇸High Point, North Carolina, United States
Site 078
🇺🇸Wilmington, North Carolina, United States
Site 048
🇺🇸Toledo, Ohio, United States
Site 029
🇺🇸Bend, Oregon, United States
Site 034
🇺🇸Anderson, South Carolina, United States
Site 067
🇺🇸Medford, Oregon, United States
Site 002
🇺🇸Duncansville, Pennsylvania, United States
Site 076
🇺🇸Charleston, South Carolina, United States
Site 009
🇺🇸Albuquerque, New Mexico, United States
Site 017
🇺🇸Hartsdale, New York, United States
Site 055
🇺🇸Austin, Texas, United States
Site 049
🇺🇸Bryan, Texas, United States
Site 093
🇺🇸Bristol, Tennessee, United States
Site 089
🇺🇸San Antonio, Texas, United States
Site 082
🇺🇸Wichita Falls, Texas, United States
Site 019
🇺🇸Draper, Utah, United States
Site 059
🇺🇸Salt Lake City, Utah, United States
Site 092
🇺🇸Norfolk, Virginia, United States
Site 026
🇺🇸Virginia Beach, Virginia, United States
Site 066
🇺🇸Bellevue, Washington, United States
Site 057
🇺🇸Renton, Washington, United States
Site 085
🇺🇸Valparaiso, Indiana, United States
Site 020
🇺🇸Worcester, Massachusetts, United States
Site 045
🇺🇸Altoona, Pennsylvania, United States
Site 056
🇺🇸Greensboro, North Carolina, United States