Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tris Pharma, Inc.
With
Forest Laboratories
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain
