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

Recruiting in Palo Alto (17 mi)

+82 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Tris Pharma, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Study Director

Principal Investigator

Grünenthal GmbH

Eligibility Criteria

Inclusion Criteria

Diagnosis of osteoarthritis (OA) of the knee

OA knee pain present for at least 3 months

OA knee pain is the predominant (ie, most painful) pain condition

Treatment Details

Interventions

• Cebranopadol (GRT6005) High-Dose Range (Other)
• Cebranopadol (GRT6005) Low-Dose Range (Other)
• Oxycodone CR (Other)
• Placebo (Other)

Participant Groups

Group I: Cebranopadol (GRT6005) Low-Dose Range Experimental Treatment 2 Interventions

Once daily GRT6005, flexible dosing 200, 300 or 400 micrograms, and once daily Placebo; oral administration for 15 weeks

Group II: Cebranopadol (GRT6005) High-Dose Range Experimental Treatment 2 Interventions

Once daily GRT6005, flexible dosing 400, 600 or 800 micrograms, and once daily Placebo; oral administration for 15 weeks

Group III: Oxycodone CR Active Control 1 Intervention

Twice daily Oxycodone CR, flexible dosing 10, 20, 30, 40 or 50 milligrams; oral administration for 15 weeks

Group IV: Placebo Placebo Group 1 Intervention

Twice daily Placebo, oral administration for 15 weeks

Who Is Running the Clinical Trial?

Tris Pharma, Inc.

Lead Sponsor

Trials

22

Recruited

4,800+

Forest Laboratories

Industry Sponsor

Trials

338

Recruited

89,200+

Founded

1956

Headquarters

New York City, USA

Known For

Depression Medications

Top Products

> Celexa, Lexapro, Namenda, Savella

Brent Saunders

Forest Laboratories

Chief Executive Officer since 2013

JD and MBA from Temple University

Marco Taglietti

Forest Laboratories

Chief Medical Officer since 2013

MD