NCT02712957

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Neomed Institute · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	NEO6860	TRPV1 antagonist
DRUG	NEO6860 placebo	Inactive substance
DRUG	Naproxen	NSAID
DRUG	Naproxen placebo	inactive substance

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-11-17
• Completion: 2016-11-24
• First posted: 2016-03-18
• Last updated: 2017-03-13

Locations

3 sites across 1 country: Canada