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

Completed · Phase 2 · Has a placebo group

Conditions studied: Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

In brief

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.

Key facts

Study ID: NCT01709214
Run by: Tris Pharma, Inc.
People needed: 619
Starts: 2012-12-04
Expected to finish: 2014-04-04
Last updated by the study team: 2021-07-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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
Site 061 — Fresno, California, United States
Site 084 — North Hollywood, California, United States
Site 080 — Roseville, California, United States
Site 004 — Sacramento, California, United States
Site 044 — San Diego, California, United States
Site 043 — Tustin, California, United States
Site 010 — Walnut Creek, California, United States
Site 027 — Westlake Village, California, United States
Site 011 — Bradenton, Florida, United States
Site 071 — Clearwater, Florida, United States
Site 090 — Edgewater, Florida, United States
Site 060 — Jacksonville, Florida, United States
Site 015 — Jupiter, Florida, United States
Site 013 — Miami, Florida, United States
Site 003 — New Port Richey, Florida, United States
Site 051 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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