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Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain | Clinical Trials | Clareo Health

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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

NCT01709214•Tris Pharma, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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
•Patients require medication on at least 4 of 7 days per week to treat OA knee pain for at least 1 month.
•Dissatisfaction with current OA knee pain treatment and willingness to stop taking all pain medications except for the study drug and allowed rescue medication
•Average daily pain rating of at least 5 on a 0 to 10 point numerical rating scale during the 1 week prior to randomization
•Female patients either postmenopausal, surgically sterile or practicing a medically acceptable method of contraception
•Male patients either status post-bilateral vasectomy or using barrier contraception

Exclusion Criteria

•Knee pain due to a disorder other than OA
•Other pain that can confound the assessment of, or contribute to, pain at the reference knee
•Surgery at the reference knee within 6 months of Screening or a history of joint replacement surgery at the reference knee
•Trauma to the reference knee within 6 months of Screening with active symptoms
•Steroid injections in the reference knee within 3 months of Screening
•Hyaluronic acid injections in the reference knee within 6 months of Screening
•Body Mass Index \> 40 kg/m2
•Patient with any protocol-excluded or clinically significant medical, surgical, or medication history that would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments

Locations (83)

Site 051

Birmingham, Alabama, United States

Site 022

Birmingham, Alabama, United States

Site 031

Huntsville, Alabama, United States

Site 005

Phoenix, Arizona, United States

Site 018

Phoenix, Arizona, United States

Site 070

Phoenix, Arizona, United States

Site 028

Tucson, Arizona, United States

Site 081

Chino, California, United States

Site 030

El Cajon, California, United States

Site 039

Fair Oaks, California, United States

Key Dates

Start Date

December 4, 2012

Primary Completion Date

April 1, 2014

Completion Date

April 4, 2014

Last Updated

July 15, 2021

Enrollment

619

ACTUAL participants

Conditions

Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

Interventions

Cebranopadol (GRT6005) Low-Dose Range

DRUG

Cebranopadol (GRT6005) High-Dose Range

DRUG

Placebo

DRUG

Oxycodone CR

DRUG