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

Pain Clinical Trial

Official title:

A Proof-of-Concept, Randomized, Double Blind, Placebo and Active Control, 3-Period, Crossover Design Study Assessing NEO6860 in Patients With Pain Associated With Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712957
• Other study ID #: NEO6860-OA-01
• Status: Completed
• Phase: Phase 2
• First received: March 9, 2016
• Last updated: March 10, 2017
• Start date: March 2016
• Est. completion date: November 24, 2016

Study information

• Verified date: March 2017
• Source: Neomed Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 24, 2016
• Est. primary completion date: November 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee
• Pain

Intervention

Drug:
• NEO6860
TRPV1 antagonist
• NEO6860 placebo
Inactive substance
• Naproxen
NSAID
• Naproxen placebo
inactive substance

Locations

Country	Name	City	State
Canada	Algorithme Pharma	Montreal	Quebec
Canada	Diex Recherche Montreal Inc	Montreal	Quebec
Canada	Diex Recherche Sherbrooke Inc	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Neomed Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Numerical Rating Scale (NRS, 0-10) from baseline after the staircase test to 8 hours post first dose after the staircase test on the index knee.	Patients are asked to step fully up onto a 8-inch (20 cm) high platform with both feet and back down a total of 24 times.	8 hours post dosing. This endpoint will be collected 3 times, 8 hours post dosing for each period: NEO6860, naproxen and placebo.
Secondary	WOMAC 3.1 Index Likert pain subscale		from baseline (screening) to 24 hour recall post 1 day treatment at each of the 3 periods
Secondary	Patient's Global Impression of Change (PGIC)		24 hour post 1 day treatment at each of the 3 periods