NCT01357837

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Tris Pharma, Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-05-23
• Last updated: 2021-07-15

Locations

26 sites across 3 countries: Austria, Poland, Spain