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

Primary Purpose

Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cebranopadol (GRT6005) Low-Dose Range
Cebranopadol (GRT6005) High-Dose Range
Placebo
Oxycodone CR
Sponsored by
Tris Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee focused on measuring Osteoarthritis, Knee, Pain, Chronic, OA, Arthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site 051
  • Site 022
  • Site 031
  • Site 005
  • Site 018
  • Site 070
  • Site 028
  • Site 081
  • Site 030
  • Site 039
  • Site 061
  • Site 084
  • Site 080
  • Site 004
  • Site 044
  • Site 043
  • Site 010
  • Site 027
  • Site 011
  • Site 071
  • Site 090
  • Site 060
  • Site 015
  • Site 013
  • Site 003
  • Site 012
  • Site 032
  • Site 025
  • Site 058
  • Site 091
  • Site 007
  • Site 052
  • Site 033
  • Site 073
  • Site 086
  • Site 041
  • Site 085
  • Site 088
  • Site 077
  • Site 083
  • Site 021
  • Site 020
  • Site 016
  • Site 042
  • Site 023
  • Site 087
  • Site 074
  • Site 024
  • Site 072
  • Site 009
  • Site 068
  • Site 017
  • Site 056
  • Site 006
  • Site 078
  • Site 079
  • Site 008
  • Site 069
  • Site 001
  • Site 048
  • Site 075
  • Site 029
  • Site 067
  • Site 035
  • Site 045
  • Site 002
  • Site 034
  • Site 076
  • Site 093
  • Site 055
  • Site 049
  • Site 038
  • Site 089
  • Site 040
  • Site 082
  • Site 019
  • Site 064
  • Site 059
  • Site 092
  • Site 026
  • Site 066
  • Site 057
  • Site 065

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

Cebranopadol (GRT6005) Low-Dose Range

Cebranopadol (GRT6005) High-Dose Range

Placebo

Oxycodone CR

Arm Description

Once daily GRT6005, flexible dosing 200, 300 or 400 micrograms, and once daily Placebo; oral administration for 15 weeks

Once daily GRT6005, flexible dosing 400, 600 or 800 micrograms, and once daily Placebo; oral administration for 15 weeks

Twice daily Placebo, oral administration for 15 weeks

Twice daily Oxycodone CR, flexible dosing 10, 20, 30, 40 or 50 milligrams; oral administration for 15 weeks

Outcomes

Primary Outcome Measures

Change from baseline in the weekly average of the daily average pain rating

Secondary Outcome Measures

Change from baseline in the physical function subscale of the Western Ontario and McMaster University Index of Osteoarthritis Questionnaire (WOMAC)

Full Information

First Posted
October 16, 2012
Last Updated
July 13, 2021
Sponsor
Tris Pharma, Inc.
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01709214
Brief Title
Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 4, 2012 (Actual)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 4, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tris Pharma, Inc.
Collaborators
Forest Laboratories

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
Keywords
Osteoarthritis, Knee, Pain, Chronic, OA, Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
619 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cebranopadol (GRT6005) Low-Dose Range
Arm Type
Experimental
Arm Description
Once daily GRT6005, flexible dosing 200, 300 or 400 micrograms, and once daily Placebo; oral administration for 15 weeks
Arm Title
Cebranopadol (GRT6005) High-Dose Range
Arm Type
Experimental
Arm Description
Once daily GRT6005, flexible dosing 400, 600 or 800 micrograms, and once daily Placebo; oral administration for 15 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Twice daily Placebo, oral administration for 15 weeks
Arm Title
Oxycodone CR
Arm Type
Active Comparator
Arm Description
Twice daily Oxycodone CR, flexible dosing 10, 20, 30, 40 or 50 milligrams; oral administration for 15 weeks
Intervention Type
Drug
Intervention Name(s)
Cebranopadol (GRT6005) Low-Dose Range
Intervention Description
Capsules
Intervention Type
Drug
Intervention Name(s)
Cebranopadol (GRT6005) High-Dose Range
Intervention Description
Capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules that did not contain active substance but appeared identical to the cebranopadol and oxycodone CR capsules
Intervention Type
Drug
Intervention Name(s)
Oxycodone CR
Intervention Description
Capsules containing oxycodone CR 10 or 20 milligrams
Primary Outcome Measure Information:
Title
Change from baseline in the weekly average of the daily average pain rating
Time Frame
Baseline to end of treatment (Week 15)
Secondary Outcome Measure Information:
Title
Change from baseline in the physical function subscale of the Western Ontario and McMaster University Index of Osteoarthritis Questionnaire (WOMAC)
Time Frame
Baseline to end of treatment (Week 15)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Grünenthal GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Site 051
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Site 022
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Site 031
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Site 005
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Site 018
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Site 070
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Site 028
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Site 081
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Site 030
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Site 039
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
Site 061
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
Facility Name
Site 084
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Site 080
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Site 004
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Site 044
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Site 043
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Site 010
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Site 027
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Site 011
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Site 071
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Site 090
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Site 060
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Site 015
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Site 013
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Site 003
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Site 012
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Site 032
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site 025
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Site 058
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Site 091
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Site 007
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34238
Country
United States
Facility Name
Site 052
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30066
Country
United States
Facility Name
Site 033
City
Perry
State/Province
Georgia
ZIP/Postal Code
31069
Country
United States
Facility Name
Site 073
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Site 086
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Site 041
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Site 085
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Site 088
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Site 077
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Site 083
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Site 021
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Site 020
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Site 016
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
Site 042
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Site 023
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Site 087
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Site 074
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Site 024
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89130
Country
United States
Facility Name
Site 072
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Site 009
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Site 068
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Site 017
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Site 056
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
Site 006
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Site 078
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Site 079
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Site 008
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Site 069
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Site 001
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Site 048
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Site 075
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Site 029
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Site 067
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Site 035
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Site 045
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Site 002
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Site 034
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Site 076
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Site 093
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Site 055
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Site 049
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Site 038
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Site 089
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Site 040
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site 082
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Site 019
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Site 064
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Site 059
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Site 092
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Site 026
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Site 066
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Site 057
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Site 065
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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