Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain
NCT ID: NCT01709214
Last Updated: 2021-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
619 participants
INTERVENTIONAL
2012-12-04
2014-04-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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) Low-Dose Range
Capsules
Placebo
Capsules that did not contain active substance but appeared identical to the cebranopadol and oxycodone CR capsules
Cebranopadol (GRT6005) High-Dose Range
Once daily GRT6005, flexible dosing 400, 600 or 800 micrograms, and once daily Placebo; oral administration for 15 weeks
Cebranopadol (GRT6005) High-Dose Range
Capsules
Placebo
Capsules that did not contain active substance but appeared identical to the cebranopadol and oxycodone CR capsules
Placebo
Twice daily Placebo, oral administration for 15 weeks
Placebo
Capsules that did not contain active substance but appeared identical to the cebranopadol and oxycodone CR capsules
Oxycodone CR
Twice daily Oxycodone CR, flexible dosing 10, 20, 30, 40 or 50 milligrams; oral administration for 15 weeks
Oxycodone CR
Capsules containing oxycodone CR 10 or 20 milligrams
Interventions
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Cebranopadol (GRT6005) Low-Dose Range
Capsules
Cebranopadol (GRT6005) High-Dose Range
Capsules
Placebo
Capsules that did not contain active substance but appeared identical to the cebranopadol and oxycodone CR capsules
Oxycodone CR
Capsules containing oxycodone CR 10 or 20 milligrams
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Tris Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Grünenthal GmbH
Locations
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Site 051
Birmingham, Alabama, United States
Site 022
Birmingham, Alabama, United States
Site 031
Huntsville, Alabama, United States
Site 005
Phoenix, Arizona, United States
Site 018
Phoenix, Arizona, United States
Site 070
Phoenix, Arizona, United States
Site 028
Tucson, Arizona, United States
Site 081
Chino, California, United States
Site 030
El Cajon, California, United States
Site 039
Fair Oaks, California, United States
Site 061
Fresno, California, United States
Site 084
North Hollywood, California, United States
Site 080
Roseville, California, United States
Site 004
Sacramento, California, United States
Site 044
San Diego, California, United States
Site 043
Tustin, California, United States
Site 010
Walnut Creek, California, United States
Site 027
Westlake Village, California, United States
Site 011
Bradenton, Florida, United States
Site 071
Clearwater, Florida, United States
Site 090
Edgewater, Florida, United States
Site 060
Jacksonville, Florida, United States
Site 015
Jupiter, Florida, United States
Site 013
Miami, 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 058
Pembroke Pines, Florida, United States
Site 091
Pinellas Park, Florida, United States
Site 007
Sarasota, Florida, United States
Site 052
Marietta, Georgia, United States
Site 033
Perry, Georgia, United States
Site 073
Stockbridge, Georgia, United States
Site 086
Chicago, Illinois, United States
Site 041
Indianapolis, Indiana, United States
Site 085
Valparaiso, Indiana, United States
Site 088
Towson, Maryland, United States
Site 077
Wheaton, Maryland, United States
Site 083
New Bedford, Massachusetts, United States
Site 021
North Dartmouth, Massachusetts, United States
Site 020
Worcester, Massachusetts, United States
Site 016
Bingham Farms, Michigan, United States
Site 042
Traverse City, Michigan, United States
Site 023
St Louis, Missouri, United States
Site 087
Grand Island, Nebraska, United States
Site 074
Omaha, Nebraska, United States
Site 024
Las Vegas, Nevada, United States
Site 072
Las Vegas, Nevada, United States
Site 009
Albuquerque, New Mexico, United States
Site 068
Albany, New York, United States
Site 017
Hartsdale, New York, United States
Site 056
Greensboro, North Carolina, United States
Site 006
High Point, North Carolina, United States
Site 078
Wilmington, North Carolina, United States
Site 079
Cincinnati, Ohio, United States
Site 008
Cincinnati, Ohio, United States
Site 069
Cleveland, Ohio, United States
Site 001
Columbus, Ohio, United States
Site 048
Toledo, Ohio, United States
Site 075
Oklahoma City, Oklahoma, United States
Site 029
Bend, Oregon, United States
Site 067
Medford, Oregon, United States
Site 035
Portland, Oregon, United States
Site 045
Altoona, Pennsylvania, United States
Site 002
Duncansville, Pennsylvania, United States
Site 034
Anderson, South Carolina, United States
Site 076
Charleston, South Carolina, United States
Site 093
Bristol, Tennessee, United States
Site 055
Austin, Texas, United States
Site 049
Bryan, Texas, United States
Site 038
Dallas, Texas, United States
Site 089
San Antonio, Texas, United States
Site 040
San Antonio, Texas, United States
Site 082
Wichita Falls, Texas, United States
Site 019
Draper, Utah, United States
Site 064
Ogden, 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 065
Seattle, Washington, United States
Countries
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Other Identifiers
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GRT-MD-101
Identifier Type: -
Identifier Source: org_study_id
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