Assessment of GRT6005 in Painful Osteoarthritis of the Knee

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grünenthal GmbH; Tris Pharma, Inc.
• Collaborator: Forest Laboratories

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.