Trial | NCT01357837  Report issue

Title

Assessment of GRT6005 in Painful Osteoarthritis of the Knee
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cebranopadol ...

  • Study Participants

    207
The purpose of the trial is to determine whether GRT6005 is effective in patients with pain due to osteoarthritis of the knee.
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 Started
May 31
2011
Primary Completion
Dec 31
2011
Study Completion
Dec 31
2011
Last Update
Jul 15
2021

Drug Matching Placebo

2 capsules of matching placebo once a day, in the morning, for a total of 28 days

Drug GRT6005

2 capsules containing a total of 75 µg GRT6005 once a day, in the morning, for a total of 28 days

Drug GRT6005

2 capsules containing a total of 200 µg GRT6005 once a day, in the morning, for a total of 28 days

Drug GRT6005

2 capsules containing a total of 400 µg GRT6005 once a day, in the morning, for a total of 28 days

Matching Placebo Placebo Comparator

Once daily oral administration of matching placebo for 4 weeks.

75 µg GRT6005 Experimental

Once daily oral administration of GRT6005 for 4 weeks.

200 µg GRT6005 Experimental

Once daily oral administration of GRT6005 for 4 weeks.

400 µg GRT6005 Experimental

Once daily oral administration of GRT6005 for 4 weeks.

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.
No Results Posted