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

Neomed Institute

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis of the Knee; Pain

Treatments: Drug: Naproxen placebo; Drug: NEO6860 placebo; Drug: NEO6860; Drug: Naproxen

Study type: Interventional

Funder types: Other

Identifiers

NCT02712957

NEO6860-OA-01

Details and patient eligibility

About

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

Full description

The study will be randomized, double blind, placebo and active control, a 3-way, 3-period crossover design, where each of the estimated 50 enrolled patients will receive alternately (i) NEO6860 (500 mg bid), (ii) placebo and (iii) Naproxen (500 mg bid). To ensure blinding, double dummy techniques will be used, so that at each period, patient will receive an oral liquid suspension (NEO6860 or its placebo) and one capsule (naproxen or its placebo).

Following a screening period, a maximum of 28 days before dosing, subjects will be randomized to one of the scheduled sequences. At each dosing period, subjects will be requested to participate in 2 clinic visits:

• One residential visit, the morning of investigational product dosing. Subjects will stay in the Clinical Research Unit approximately 13 hours
• One end of period visit, 24 h after first dosing A total of 2 washout periods of 1 to 3 weeks will separate the dosing periods. Once the 3 dosing periods will be completed, the subjects will come back to the clinic for a follow up visit (7 to 10 days post last dose).

Note: for a subpopulation, at one site, an assessment of heat pain threshold and tolerance will be conducted requiring a residential period of approximately 24 hours.

Enrollment: 54 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

54 participants in 3 patient groups, including a placebo group

NEO6860

Experimental group

Description:

NEO6860 is provided as a powder in individual containers to be reconstituted as a suspension. In this arm patients will receive both NEO6860 and a placebo of naproxen.

Treatment:

Drug: Naproxen placebo

Drug: NEO6860

Placebo

Placebo Comparator group

Description:

In this arm, patients will receive both placebo: oral liquid suspension (NEO6860 placebo) and capsule (naproxen placebo).

Treatment:

Drug: Naproxen placebo

Drug: NEO6860 placebo

Naproxen

Active Comparator group

Description:

Naproxen is provided as over-encapsulated tablets using a commercially approved medication. In this arm patients will receive both naproxen and a placebo of NEO6860.

Treatment:

Drug: NEO6860 placebo

Drug: Naproxen