NCT01709214

Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain

A Randomized, Double-Blind, Placebo- and Active Controlled Study to Evaluate the Safety and Efficacy of GRT6005 in Patients With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 619 (actual)
• Sponsor: Tris Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of GRT6005 compared to placebo in patients with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. This study includes a maximum 21 day Screening Period followed by a 15-week Double-blind Treatment Period and a 4-7 day Safety Follow-up period. Patients who are eligible for the Double-blind Treatment Period will be randomized to one of following treatment groups: GRT6005 high-dose range (400, 600 or 800 mcg), GRT6005 low-dose range (200, 300 or 400 mcg), oxycodone controlled release (CR) dose range (10, 20, 30, 40 or 50 mg) or placebo.

Conditions

• Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	Cebranopadol (GRT6005) Low-Dose Range	Capsules
DRUG	Cebranopadol (GRT6005) High-Dose Range	Capsules
DRUG	Placebo	Capsules that did not contain active substance but appeared identical to the cebranopadol and oxycodone CR capsules
DRUG	Oxycodone CR	Capsules containing oxycodone CR 10 or 20 milligrams

Timeline

• Start date: 2012-12-04
• Primary completion: 2014-04-01
• Completion: 2014-04-04
• First posted: 2012-10-18
• Last updated: 2021-07-15

Locations

83 sites across 1 country: United States

Regulatory

• FDA-regulated drug study