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

NCT ID: NCT02712957

Last Updated: 2017-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-11-24

Brief 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.

Detailed 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.

Conditions

Pain; Osteoarthritis of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NEO6860

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.

Group Type: EXPERIMENTAL

NEO6860

Intervention Type: DRUG

TRPV1 antagonist

Naproxen placebo

Intervention Type: DRUG

inactive substance

Placebo

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

Group Type: PLACEBO_COMPARATOR

NEO6860 placebo

Intervention Type: DRUG

Inactive substance

Naproxen placebo

Intervention Type: DRUG

inactive substance

Naproxen

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.

Group Type: ACTIVE_COMPARATOR

NEO6860 placebo

Intervention Type: DRUG

Inactive substance

Naproxen

Intervention Type: DRUG

NSAID

Interventions

NEO6860

TRPV1 antagonist

Intervention Type: DRUG

NEO6860 placebo

Inactive substance

Intervention Type: DRUG

Naproxen

NSAID

Intervention Type: DRUG

Naproxen placebo

inactive substance

Intervention Type: DRUG

Eligibility 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;

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neomed Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dan A Chiche, MD

Role: STUDY_DIRECTOR

Neomed Institute

Locations

Diex Recherche Montreal Inc

Montreal, Quebec, Canada

Algorithme Pharma

Montreal, Quebec, Canada

Diex Recherche Sherbrooke Inc

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

NEO6860-OA-01

Identifier Type: -

Identifier Source: org_study_id