Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-25 @ 4:20 PM
Study NCT ID:
NCT02712957
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2016-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Proof-of-Concept Study Assessing NEO6860 in Osteoarthritis Pain
Sponsor:
Neomed Institute
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: