Assessment of GRT6005 in Painful Osteoarthritis of the Knee
A Randomized 4 Week Phase IIa Trial Evaluating the Efficacy, Safety, and Tolerability of GRT6005, a New Centrally Acting Analgesic, in Subjects With Moderate to Severe Pain Due to Osteoarthritis (OA) of the Knee
3 other identifiers
interventional
207
3 countries
26
Brief Summary
The purpose of the trial is to determine whether GRT6005 is effective in patients with pain due to osteoarthritis of the knee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2011
Shorter than P25 for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 19, 2011
CompletedFirst Posted
Study publicly available on registry
May 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJuly 15, 2021
July 1, 2021
7 months
May 19, 2011
July 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the pain intensity scores during the last week of the 4-week treatment period
4 weeks
Secondary Outcomes (13)
Change from baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the 4 week treatment period
4 weeks
Change from baseline in quality of health as measured by Short Form-12 Health Survey
4 weeks
Response measured in percentage change of pain intensity since baseline
4 weeks
Leeds Sleep Evaluation Questionnaire to quantify subjective impressions of sleep and waking
4 weeks
Patient's Global Impression of Change (PGIC)
4 weeks
- +8 more secondary outcomes
Study Arms (4)
Matching Placebo
PLACEBO COMPARATOROnce daily oral administration of matching placebo for 4 weeks.
75 µg GRT6005
EXPERIMENTALOnce daily oral administration of GRT6005 for 4 weeks.
200 µg GRT6005
EXPERIMENTALOnce daily oral administration of GRT6005 for 4 weeks.
400 µg GRT6005
EXPERIMENTALOnce daily oral administration of GRT6005 for 4 weeks.
Interventions
2 capsules of matching placebo once a day, in the morning, for a total of 28 days
2 capsules containing a total of 75 µg GRT6005 once a day, in the morning, for a total of 28 days
Eligibility Criteria
You may qualify if:
- painful Osteoarthritis of the knee based on American College of Rheumatology Criteria
- signed informed consent
- on stable analgesic medications for painful osteoarthritis with regular analgesic intake for at least 3 months
- pain intensity score of 4 or greater on the 11-point numeric rating scale (where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine").
You may not qualify if:
- Substance Abuse
- Significant cardiac disease
- Presence of risk factors for Torsades de Pointes and chronic severe cardiac disease
- History of seizure disorder
- Chronic gastrointestinal disease
- Conditions that contribute and confound to the assessment of pain
- Surgery or painful procedure during or within 3 months of enrollment
- Cancer
- Subjects with impaired renal function
- Subjects with impaired hepatic function
- Female subjects who are breastfeeding
- History of chronic hepatitis B or C or human immunodeficiency virus infection, or presence of acute hepatitis A, B, or C within the past 3 months.
- Clinically relevant history of hypersensitivity or allergy to paracetamol, opioids or the excipients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tris Pharma, Inc.lead
- Forest Laboratoriescollaborator
Study Sites (26)
Site 3604
Linz, 4021, Austria
Site 3605
Senftenberg, 3541, Austria
Site 3603
Vienna, 1090, Austria
Site 3602
Vienna, 1100, Austria
Site 3601
Vienna, 1130, Austria
Site 3203
Bialystok, 15-337, Poland
Site 3202
Elblag, 82-300, Poland
Site 3208
Gdynia, 81-834, Poland
Site 3206
Krakow, 30-349, Poland
Site 3207
Lublin, 20-605, Poland
Site 3210
Szczecin, 71-252, Poland
Site 3201
Torun, 87-100, Poland
Site 3211
Warsaw, 02-730, Poland
Site 3204
Warsaw, Poland
Site 3205
Wroclaw, 50-088, Poland
Site 3213
Włoszczowa, 29-100, Poland
Site 3303
A Coruña, 15006, Spain
Site 3305
Barcelona, 08028, Spain
Site 3302
Barcelona, 08034, Spain
Site 3312
Málaga, 29009, Spain
Site 3308
Mérida, 06800, Spain
Site 3310
Oviedo, 33009, Spain
Site 3311
Petrel, 03610, Spain
Site 3304
Santiago de Compostela, 15705, Spain
Site 3306
Seville, 41009, Spain
Site 3313
Torrelavega, 39300, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacek Olas, MD
Specjalistyczne Centrum Medyczne NZOZ NOWOMED,
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2011
First Posted
May 23, 2011
Study Start
May 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
July 15, 2021
Record last verified: 2021-07