Assessment of GRT6005 in Painful Osteoarthritis of the Knee

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

Detailed Description
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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.

Official Title
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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

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: Matching Placebo
* Drug: GRT6005
* Drug: GRT6005
* Drug: GRT6005


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Matching Placebo<br>Once daily oral administration of matching placebo for 4 weeks. | Drug: Matching Placebo<br>* 2 capsules of matching placebo once a day, in the morning, for a total of 28 days<br>|
| Experimental: 75 µg GRT6005<br>Once daily oral administration of GRT6005 for 4 weeks. | Drug: GRT6005<br>* 2 capsules containing a total of 75 µg GRT6005 once a day, in the morning, for a total of 28 days<br>|
| Experimental: 200 µg GRT6005<br>Once daily oral administration of GRT6005 for 4 weeks. | Drug: GRT6005<br>* 2 capsules containing a total of 200 µg GRT6005 once a day, in the morning, for a total of 28 days<br>|
| Experimental: 400 µg GRT6005<br>Once daily oral administration of GRT6005 for 4 weeks. | Drug: GRT6005<br>* 2 capsules containing a total of 400 µg GRT6005 once a day, in the morning, for a total of 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the pain intensity scores during the last week of the 4-week treatment period |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Clinician's Global Impression of Change (CGIC) |  | 4 weeks | 
| Weekly current pain intensity changes from baseline |  | 4 weeks | 
| Rescue medication use |  | 4 weeks | 
| Quality of Life EuroQoL-5 Dimension score, change from baseline |  | 4 weeks | 
| Clinical Opioid Withdrawal Scale |  | 4 weeks | 
| Plasma concentration |  | 4 weeks | 
| Discontinuation from study due to treatment related adverse events |  | 4 weeks | 
| Time to withdrawal from study |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, knee, Analgesia, Pain, Painful