Clinical trial NCT01709214: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
Keywords: Osteoarthritis
Knee
Pain
Chronic
OA
Arthritis
Lead sponsor: Tris Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Forest Laboratories
First posted: 2012-10-18
Enrollment: 619
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline in the weekly average of the daily average pain rating
timeFrame: Baseline to end of treatment (Week 15)
Secondary outcomes:
measure: Change from baseline in the physical function subscale of the Western Ontario and McMaster University Index of Osteoarthritis Questionnaire (WOMAC)
timeFrame: Baseline to end of treatment (Week 15)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 051
state: Alabama
city: Birmingham
country: United States
facility: Site 022
state: Alabama
city: Huntsville
country: United States
facility: Site 031
state: Alabama
city: Phoenix
country: United States
facility: Site 005
state: Arizona
city: Phoenix
country: United States
facility: Site 018
state: Arizona
city: Phoenix
country: United States
facility: Site 070
state: Arizona
city: Tucson
country: United States
facility: Site 028
state: Arizona
city: Chino
country: United States
facility: Site 081
state: California
city: El Cajon
country: United States
facility: Site 030
state: California
city: Fair Oaks
country: United States
facility: Site 039
state: California
city: Fresno
country: United States
facility: Site 061
state: California
city: North Hollywood
country: United States
facility: Site 084
state: California
city: Roseville
country: United States
facility: Site 080
state: California
city: Sacramento
country: United States
facility: Site 004
state: California
city: San Diego
country: United States
facility: Site 044
state: California
city: Tustin
country: United States
facility: Site 043
state: California
city: Walnut Creek
country: United States
facility: Site 010
state: California
city: Westlake Village
country: United States
facility: Site 027
state: California
city: Bradenton
country: United States
facility: Site 011
state: Florida
city: Clearwater
country: United States
facility: Site 071
state: Florida
city: Edgewater
country: United States
facility: Site 090
state: Florida
city: Jacksonville
country: United States
facility: Site 060
state: Florida
city: Jupiter
country: United States
facility: Site 015
state: Florida
city: Miami
country: United States
facility: Site 013
state: Florida
city: New Port Richey
country: United States
facility: Site 003
state: Florida
city: Ocala
country: United States
facility: Site 012
state: Florida
city: Orlando
country: United States
facility: Site 032
state: Florida
city: Ormond Beach
country: United States
facility: Site 025
state: Florida
city: Pembroke Pines
country: United States
facility: Site 058
state: Florida
city: Pinellas Park
country: United States
facility: Site 091
state: Florida
city: Sarasota
country: United States
facility: Site 007
state: Florida
city: Marietta
country: United States
facility: Site 052
state: Georgia
city: Perry
country: United States
facility: Site 033
state: Georgia
city: Stockbridge
country: United States
facility: Site 073
state: Georgia
city: Chicago
country: United States
facility: Site 086
state: Illinois
city: Indianapolis
country: United States
facility: Site 041
state: Indiana
city: Valparaiso
country: United States
facility: Site 085
state: Indiana
city: Towson
country: United States
facility: Site 088
state: Maryland
city: Wheaton
country: United States
facility: Site 077
state: Maryland
city: New Bedford
country: United States
facility: Site 083
state: Massachusetts
city: North Dartmouth
country: United States
facility: Site 021
state: Massachusetts
city: Worcester
country: United States
facility: Site 020
state: Massachusetts
city: Bingham Farms
country: United States
facility: Site 016
state: Michigan
city: Traverse City
country: United States
facility: Site 042
state: Michigan
city: Saint Louis
country: United States
facility: Site 023
state: Missouri
city: Grand Island
country: United States
facility: Site 087
state: Nebraska
city: Omaha
country: United States
facility: Site 074
state: Nebraska
city: Las Vegas
country: United States
facility: Site 024
state: Nevada
city: Las Vegas
country: United States
facility: Site 072
state: Nevada
city: Albuquerque
country: United States
facility: Site 009
state: New Mexico
city: Albany
country: United States
facility: Site 068
state: New York
city: Hartsdale
country: United States
facility: Site 017
state: New York
city: Greensboro
country: United States
facility: Site 056
state: North Carolina
city: High Point
country: United States
facility: Site 006
state: North Carolina
city: Wilmington
country: United States
facility: Site 078
state: North Carolina
city: Cincinnati
country: United States
facility: Site 079
state: Ohio
city: Cincinnati
country: United States
facility: Site 008
state: Ohio
city: Cleveland
country: United States
facility: Site 069
state: Ohio
city: Columbus
country: United States
facility: Site 001
state: Ohio
city: Toledo
country: United States
facility: Site 048
state: Ohio
city: Oklahoma City
country: United States
facility: Site 075
state: Oklahoma
city: Bend
country: United States
facility: Site 029
state: Oregon
city: Medford
country: United States
facility: Site 067
state: Oregon
city: Portland
country: United States
facility: Site 035
state: Oregon
city: Altoona
country: United States
facility: Site 045
state: Pennsylvania
city: Duncansville
country: United States
facility: Site 002
state: Pennsylvania
city: Anderson
country: United States
facility: Site 034
state: South Carolina
city: Charleston
country: United States
facility: Site 076
state: South Carolina
city: Bristol
country: United States
facility: Site 093
state: Tennessee
city: Austin
country: United States
facility: Site 055
state: Texas
city: Bryan
country: United States
facility: Site 049
state: Texas
city: Dallas
country: United States
facility: Site 038
state: Texas
city: San Antonio
country: United States
facility: Site 089
state: Texas
city: San Antonio
country: United States
facility: Site 040
state: Texas
city: Wichita Falls
country: United States
facility: Site 082
state: Texas
city: Draper
country: United States
facility: Site 019
state: Utah
city: Ogden
country: United States
facility: Site 064
state: Utah
city: Salt Lake City
country: United States
facility: Site 059
state: Utah
city: Norfolk
country: United States
facility: Site 092
state: Virginia
city: Virginia Beach
country: United States
facility: Site 026
state: Virginia
city: Bellevue
country: United States
facility: Site 066
state: Washington
city: Renton
country: United States
facility: Site 057
state: Washington
city: Seattle
country: United States
facility: Site 065
state: Washington
Study officials:
affiliation: Grünenthal GmbH
name: Study Director
role: STUDY_DIRECTOR
References: