Ignite Creation Date:
2024-05-06 @ 8:20 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02712957
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2016-03-09
Brief Title:
A Proof-of-Concept Study Assessing NEO6860 in Osteoarthritis Pain
Sponsor:
Neomed Institute
Organization:
Neomed Institute
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:
None
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?:
None