Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-29 @ 4:18 AM
Study NCT ID:
NCT01619150
Status:
COMPLETED
Last Update Posted:
2013-07-23
First Post:
2012-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Center 2-way Crossover Study to Investigate the Mechanism of Action of Etoricoxib in Subjects With Osteoarthritis Knee Pain
Sponsor:
C4Pain
Organization:
Study Overview
Official Title:
A Single Center, Randomized, Double-blind, Placebo-controlled 2-way Crossover Study to Investigate the Mechanism of Action of Etoricoxib in Subjects With Osteoarthritis Knee Pain.
Status:
COMPLETED
Status Verified Date:
2013-07
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 investigate which pain mechanisms that can be affected by etoricoxib compared to placebo (inactive medication)in subjects with painful knee osteoarthritis af 4 weeks of treatment.
Detailed Description:
Study Rationale: The purpose of this study is to investigate which pain mechanisms in subjects with painful knee osteoarthritis can be affected by the peripheral and central actions of etoricoxib as compared to placebo during a 4 week treatment therapy period.
The present study will utilize a set of quantitative mechanism based pain biomarkers to assess peripheral and central pain manifestations in OA and the influence of etoricoxib on those individual manifestations in an attempt to understand and explain clinical pain alleviation.
Study Treatment: Subjects will be randomized to one of the 2 sequences of treatment: Sequence 1 (60 mg/day etoricoxib followed by placebo) or Sequence 2 (placebo followed by 60 mg/day etoricoxib). The two treatment periods of 4 weeks each are separated by a washout period of at least 6 days.
Primary Objective: To assess which pain mechanisms are modulated by 60 mg daily administration of etoricoxib compared to placebo in subjects with osteoarthritic (OA) knee pain during two treatment periods of 4-weeks each.
Secondary Objectives: To evaluate if changes in any of the mechanism based experimental pain assessment parameters can explain changes in clinical outcome parameters.
To profile drug responders- versus non-responders based on pain mechanisms involved.
To investigate if change in inflammatory, bone and cartilage related bio-chemical biomarkers can explain changes in either experimental or clinical pain parameters.
The present study will utilize a set of quantitative mechanism based pain biomarkers to assess peripheral and central pain manifestations in OA and the influence of etoricoxib on those individual manifestations in an attempt to understand and explain clinical pain alleviation.
Study Treatment: Subjects will be randomized to one of the 2 sequences of treatment: Sequence 1 (60 mg/day etoricoxib followed by placebo) or Sequence 2 (placebo followed by 60 mg/day etoricoxib). The two treatment periods of 4 weeks each are separated by a washout period of at least 6 days.
Primary Objective: To assess which pain mechanisms are modulated by 60 mg daily administration of etoricoxib compared to placebo in subjects with osteoarthritic (OA) knee pain during two treatment periods of 4-weeks each.
Secondary Objectives: To evaluate if changes in any of the mechanism based experimental pain assessment parameters can explain changes in clinical outcome parameters.
To profile drug responders- versus non-responders based on pain mechanisms involved.
To investigate if change in inflammatory, bone and cartilage related bio-chemical biomarkers can explain changes in either experimental or clinical pain parameters.
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?: