Clinical trial NCT01357837: Assessment of GRT6005 in Painful Osteoarthritis of the Knee
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis, knee
Analgesia
Pain
Painful
Lead sponsor: Tris Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Forest Laboratories
First posted: 2011-05-23
Enrollment: 207
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to determine whether GRT6005 is effective in patients with pain due to osteoarthritis of the knee.

Detailed description: The purpose of this study is to evaluate the safety, tolerability and efficacy of 3 doses of GRT6005 taken once daily for 4 weeks in outpatients with moderate-to-severe painful osteoarthritis of the knee.

Eligibility criteria: Inclusion Criteria:

* 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").

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline in the pain intensity scores during the last week of the 4-week treatment period
timeFrame: 4 weeks
Secondary outcomes:
measure: 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
timeFrame: 4 weeks
measure: Change from baseline in quality of health as measured by Short Form-12 Health Survey
timeFrame: 4 weeks
measure: Response measured in percentage change of pain intensity since baseline
timeFrame: 4 weeks
measure: Leeds Sleep Evaluation Questionnaire to quantify subjective impressions of sleep and waking
timeFrame: 4 weeks
measure: Patient's Global Impression of Change (PGIC)
timeFrame: 4 weeks
measure: Clinician's Global Impression of Change (CGIC)
timeFrame: 4 weeks
measure: Weekly current pain intensity changes from baseline
timeFrame: 4 weeks
measure: Rescue medication use
timeFrame: 4 weeks
measure: Quality of Life EuroQoL-5 Dimension score, change from baseline
timeFrame: 4 weeks
measure: Clinical Opioid Withdrawal Scale
timeFrame: 4 weeks
measure: Plasma concentration
timeFrame: 4 weeks
measure: Discontinuation from study due to treatment related adverse events
timeFrame: 4 weeks
measure: Time to withdrawal from study
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Site 3604
city: Senftenberg
country: Austria
facility: Site 3605
city: Wien
country: Austria
facility: Site 3603
city: Wien
country: Austria
facility: Site 3602
city: Wien
country: Austria
facility: Site 3601
city: Bialystok
country: Poland
facility: Site 3203
city: Elblag
country: Poland
facility: Site 3202
city: Gdynia
country: Poland
facility: Site 3208
city: Krakow
country: Poland
facility: Site 3206
city: Lublin
country: Poland
facility: Site 3207
city: Szczecin
country: Poland
facility: Site 3210
city: Torun
country: Poland
facility: Site 3201
city: Warsawa
country: Poland
facility: Site 3204
city: Warszawa
country: Poland
facility: Site 3211
city: Wloszczowa
country: Poland
facility: Site 3213
city: Wroclaw
country: Poland
facility: Site 3205
city: Barcelona
country: Spain
facility: Site 3305
city: Barcelona
country: Spain
facility: Site 3302
city: Coruna
country: Spain
facility: Site 3303
city: Málaga
country: Spain
facility: Site 3312
city: Mérida
country: Spain
facility: Site 3308
city: Oviedo
country: Spain
facility: Site 3310
city: Petrel
country: Spain
facility: Site 3311
city: Santiago de Compostela
country: Spain
facility: Site 3304
city: Sevilla
country: Spain
facility: Site 3306
city: Torrelavega
country: Spain
facility: Site 3313
Study officials:
affiliation: Specjalistyczne Centrum Medyczne NZOZ NOWOMED,
name: Jacek Olas, MD
role: PRINCIPAL_INVESTIGATOR
References: