Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain
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
1 other identifier
interventional
619
1 country
83
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2012
Shorter than P25 for phase_2
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2012
CompletedFirst Posted
Study publicly available on registry
October 18, 2012
CompletedStudy Start
First participant enrolled
December 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2014
CompletedJuly 15, 2021
July 1, 2021
1.3 years
October 16, 2012
July 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the weekly average of the daily average pain rating
Baseline to end of treatment (Week 15)
Secondary Outcomes (1)
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)
Study Arms (4)
Cebranopadol (GRT6005) Low-Dose Range
EXPERIMENTALOnce daily GRT6005, flexible dosing 200, 300 or 400 micrograms, and once daily Placebo; oral administration for 15 weeks
Cebranopadol (GRT6005) High-Dose Range
EXPERIMENTALOnce daily GRT6005, flexible dosing 400, 600 or 800 micrograms, and once daily Placebo; oral administration for 15 weeks
Placebo
PLACEBO COMPARATORTwice daily Placebo, oral administration for 15 weeks
Oxycodone CR
ACTIVE COMPARATORTwice daily Oxycodone CR, flexible dosing 10, 20, 30, 40 or 50 milligrams; oral administration for 15 weeks
Interventions
Capsules that did not contain active substance but appeared identical to the cebranopadol and oxycodone CR capsules
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tris Pharma, Inc.lead
- Forest Laboratoriescollaborator
Study Sites (83)
Site 051
Birmingham, Alabama, 35209, United States
Site 022
Birmingham, Alabama, 35216, United States
Site 031
Huntsville, Alabama, 35801, United States
Site 005
Phoenix, Arizona, 85018, United States
Site 018
Phoenix, Arizona, 85023, United States
Site 070
Phoenix, Arizona, 85027, United States
Site 028
Tucson, Arizona, 85712, United States
Site 081
Chino, California, 91710, United States
Site 030
El Cajon, California, 92020, United States
Site 039
Fair Oaks, California, 95628, United States
Site 061
Fresno, California, 93726, United States
Site 084
North Hollywood, California, 91606, United States
Site 080
Roseville, California, 95661, United States
Site 004
Sacramento, California, 95821, United States
Site 044
San Diego, California, 92117, United States
Site 043
Tustin, California, 92780, United States
Site 010
Walnut Creek, California, 94598, United States
Site 027
Westlake Village, California, 91361, United States
Site 011
Bradenton, Florida, 34209, United States
Site 071
Clearwater, Florida, 33761, United States
Site 090
Edgewater, Florida, 32132, United States
Site 060
Jacksonville, Florida, 32256, United States
Site 015
Jupiter, Florida, 33458, United States
Site 013
Miami, Florida, 33144, United States
Site 003
New Port Richey, Florida, 34652, United States
Site 012
Ocala, Florida, 34474, United States
Site 032
Orlando, Florida, 32806, United States
Site 025
Ormond Beach, Florida, 32174, United States
Site 058
Pembroke Pines, Florida, 33028, United States
Site 091
Pinellas Park, Florida, 33781, United States
Site 007
Sarasota, Florida, 34238, United States
Site 052
Marietta, Georgia, 30066, United States
Site 033
Perry, Georgia, 31069, United States
Site 073
Stockbridge, Georgia, 30281, United States
Site 086
Chicago, Illinois, 60612, United States
Site 041
Indianapolis, Indiana, 46260, United States
Site 085
Valparaiso, Indiana, 46383, United States
Site 088
Towson, Maryland, 21204, United States
Site 077
Wheaton, Maryland, 20902, United States
Site 083
New Bedford, Massachusetts, 02740, United States
Site 021
North Dartmouth, Massachusetts, 02747, United States
Site 020
Worcester, Massachusetts, 01605, United States
Site 016
Bingham Farms, Michigan, 48025, United States
Site 042
Traverse City, Michigan, 49684, United States
Site 023
St Louis, Missouri, 63141, United States
Site 087
Grand Island, Nebraska, 68803, United States
Site 074
Omaha, Nebraska, 68144, United States
Site 024
Las Vegas, Nevada, 89130, United States
Site 072
Las Vegas, Nevada, 89144, United States
Site 009
Albuquerque, New Mexico, 87102, United States
Site 068
Albany, New York, 12208, United States
Site 017
Hartsdale, New York, 10530, United States
Site 056
Greensboro, North Carolina, 27410, United States
Site 006
High Point, North Carolina, 27262, United States
Site 078
Wilmington, North Carolina, 28401, United States
Site 079
Cincinnati, Ohio, 45219, United States
Site 008
Cincinnati, Ohio, 45242, United States
Site 069
Cleveland, Ohio, 44122, United States
Site 001
Columbus, Ohio, 43213, United States
Site 048
Toledo, Ohio, 43623, United States
Site 075
Oklahoma City, Oklahoma, 73103, United States
Site 029
Bend, Oregon, 97701, United States
Site 067
Medford, Oregon, 97504, United States
Site 035
Portland, Oregon, 97239, United States
Site 045
Altoona, Pennsylvania, 16602, United States
Site 002
Duncansville, Pennsylvania, 16635, United States
Site 034
Anderson, South Carolina, 29621, United States
Site 076
Charleston, South Carolina, 29407, United States
Site 093
Bristol, Tennessee, 37620, United States
Site 055
Austin, Texas, 78731, United States
Site 049
Bryan, Texas, 77802, United States
Site 038
Dallas, Texas, 75203, United States
Site 089
San Antonio, Texas, 78209, United States
Site 040
San Antonio, Texas, 78229, United States
Site 082
Wichita Falls, Texas, 76309, United States
Site 019
Draper, Utah, 84020, United States
Site 064
Ogden, Utah, 84405, United States
Site 059
Salt Lake City, Utah, 84106, United States
Site 092
Norfolk, Virginia, 23507, United States
Site 026
Virginia Beach, Virginia, 23454, United States
Site 066
Bellevue, Washington, 98007, United States
Site 057
Renton, Washington, 98057, United States
Site 065
Seattle, Washington, 98122, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Grünenthal GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2012
First Posted
October 18, 2012
Study Start
December 4, 2012
Primary Completion
April 1, 2014
Study Completion
April 4, 2014
Last Updated
July 15, 2021
Record last verified: 2021-07