A Proof-of-Concept Study Assessing NEO6860 in Osteoarthritis Pain

• Status: Completed
• Trial end date: 2016-11-24
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess NEO6860, a modality selective TRPV1 antagonist, in patients with pain associated with osteoarthritis of the knee.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neomed Institute
• Treatments: Naproxen

Criteria

Inclusion Criteria:

• Body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive;

• Patients diagnosed with osteoarthritis of the knee, according to American College of Rheumatology (ACR) guidelines, by meeting at least 3 of the following: age > 50, morning stiffness < 30 minutes, crepitus on active motion, bone tenderness, bone enlargement, no palpable warmth of synovium;

• Grade I, II or III using Kellgren-Lawrence classification on an X-Ray of the knee

• WOMAC pain subscale ≥ 8

• R square of the Focused Analgesia Selection Task (FAST) outcome value greater than 0.70

Exclusion Criteria:

• Patients with, or with a history of, any clinically significant disorders (including fibromyalgia and other painful disorders) which may interfere with the primary objectives of the study

• Patients treated in the previous 3 months with topical capsaicin or intra-articular corticosteroids;

• Patients with a contra-indication for the use of Naproxen or acetaminophen;