Assessment of GRT6005 in Painful Osteoarthritis of the Knee

Tris Pharma

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis of the Knee

Treatments: Drug: GRT6005; Drug: Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01357837

116918

KF6005/03 (Other Identifier)

2010-022556-23 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 207 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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207 participants in 4 patient groups, including a placebo group

Matching Placebo

Placebo Comparator group

Description:

Once daily oral administration of matching placebo for 4 weeks.

Treatment:

Drug: Matching Placebo

75 µg GRT6005

Experimental group

Description:

Once daily oral administration of GRT6005 for 4 weeks.

Treatment:

Drug: GRT6005

Drug: GRT6005

Drug: GRT6005

200 µg GRT6005

Experimental group

Description:

Once daily oral administration of GRT6005 for 4 weeks.

Treatment:

Drug: GRT6005

Drug: GRT6005

Drug: GRT6005

400 µg GRT6005

Experimental group

Description:

Once daily oral administration of GRT6005 for 4 weeks.

Treatment:

Drug: GRT6005

Drug: GRT6005

Drug: GRT6005