Assessment of GRT6005 in Painful Osteoarthritis of the Knee

Phase 2

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Drug: GRT6005; Drug: Matching Placebo

• Registration Number: NCT01357837
• Lead Sponsor: Tris Pharma, Inc.

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-19
• Study First Submitted QC: 2011-05-20
• Study First Posted: 2011-05-23
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
75 µg GRT6005	GRT6005	Once daily oral administration of GRT6005 for 4 weeks.
Matching Placebo	Matching Placebo	Once daily oral administration of matching placebo for 4 weeks.
200 µg GRT6005	GRT6005	Once daily oral administration of GRT6005 for 4 weeks.
400 µg GRT6005	GRT6005	Once daily oral administration of GRT6005 for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the pain intensity scores during the last week of the 4-week treatment period	4 weeks

Secondary Outcome Measures

Name	Time	Method
Patient's Global Impression of Change (PGIC)	4 weeks
Weekly current pain intensity changes from baseline	4 weeks
Rescue medication use	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
Clinician's Global Impression of Change (CGIC)	4 weeks
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
Plasma concentration	4 weeks
Time to withdrawal from study	4 weeks
Leeds Sleep Evaluation Questionnaire to quantify subjective impressions of sleep and waking	4 weeks
Quality of Life EuroQoL-5 Dimension score, change from baseline	4 weeks
Clinical Opioid Withdrawal Scale	4 weeks
Discontinuation from study due to treatment related adverse events	4 weeks

Trial Locations

Locations (26)

Site 3604; 🇦🇹 Linz, Austria

Site 3605; 🇦🇹 Senftenberg, Austria

Site 3603; 🇦🇹 Wien, Austria

Site 3602; 🇦🇹 Wien, Austria

Site 3601; 🇦🇹 Wien, Austria

Site 3208; 🇵🇱 Gdynia, Poland

Site 3206; 🇵🇱 Krakow, Poland

Site 3210; 🇵🇱 Szczecin, Poland

Site 3204; 🇵🇱 Warsawa, Poland

Site 3207; 🇵🇱 Lublin, Poland

Site 3213; 🇵🇱 Wloszczowa, Poland

Site 3203; 🇵🇱 Bialystok, Poland

Site 3202; 🇵🇱 Elblag, Poland

Site 3201; 🇵🇱 Torun, Poland

Site 3211; 🇵🇱 Warszawa, Poland

Site 3312; 🇪🇸 Málaga, Spain

Site 3205; 🇵🇱 Wroclaw, Poland

Site 3305; 🇪🇸 Barcelona, Spain

Site 3303; 🇪🇸 Coruna, Spain

Site 3302; 🇪🇸 Barcelona, Spain

Site 3310; 🇪🇸 Oviedo, Spain

Site 3311; 🇪🇸 Petrel, Spain

Site 3304; 🇪🇸 Santiago de Compostela, Spain

Site 3306; 🇪🇸 Sevilla, Spain

Site 3308; 🇪🇸 Mérida, Spain

Site 3313; 🇪🇸 Torrelavega, Spain