Evaluation of the Efficacy, Tolerability and Safety of Etoricoxib (Arcoxia) in Patients With Neuropathic Pain
Recruitment status was: Recruiting
The present study will aim to determine the safety, efficacy, and tolerability of etoricoxib, an NSAID pain reliever, in patients with Neuropathic pain. Neuropathic pain, or pain caused by abnormal activity of sensory neurons, remains undertreated. Post herpetic neuralgia (PHN), which is commonly referred to as post-shingles pain, is the most useful disease to study when investigating the efficacy of pain relievers for Neuropathic pain. Therefore, this study will primarily involve patients with PHN.
The hypothesis in this study is that etoricoxib efficacy is superior to that of placebo.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||An Enriched Enrollment, Double-Blind, Placebo-Controlled, Parallel Group, Randomized Withdrawal Trial to Evaluate the Efficacy, Tolerability and Safety of Etoricoxib (Arcoxia) in Patients With Moderate to Severe Neuropathic Pain|
- Time to Efficacy Failure [ Time Frame: 28 Days ] [ Designated as safety issue: No ]To compare the efficacy of etoricoxib to placebo in reducing pain intensity in patients with NP, as measured by Time to Efficacy Failure during the Double-Blind Period.
- To evaluate the efficacy of etoricoxib in NP during the Open-Label and the Double-Blind Periods [ Time Frame: 42 Days ] [ Designated as safety issue: No ]
- Time to efficacy failure by PHN sub-group based on sensory testing results [ Time Frame: 42 Days ] [ Designated as safety issue: No ]
- Safety as assessed by adverse events, serious adverse events, and vital signs [ Time Frame: 56 Days ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||April 2012|
|Estimated Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
The study will use an Enriched Enrollment Randomized Withdrawal (EERW) design consisting of a 2-week open-label enrichment phase, during which subjects will receive etoricoxib. Patients who experience at least a 30% reduction in pain intensity will be randomized to either continued treatment with etoricoxib 90 mg qd or matching placebo (at a 1:1 ratio) for 4 weeks.
90mg Tablet QD at 10:00a.m.
Other Name: Arcoxia
Placebo Comparator: Placebo
The study will use an Enriched Enrollment Randomized Withdrawal (EERW) design consisting of a 2-week open-label enrichment phase, during which subjects will receive etoricoxib, followed by a 4-week randomized, double-blind, placebo-controlled treatment phase, during which subjects will receive either etoricoxib or placebo.
One tablet QD at 10:00a.m.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264237
|MAC (UK) Neruoscience Ltd|
|Liverpool, United Kingdom, L18 1HQ|
|MAC (UK) Neuroscience Ltd|
|Manchester, United Kingdom, M32 0UT|
|Principal Investigator:||Stuart Ratcliffe, MBChB, MFPM, FRSM||MAC (UK) Neuroscience Ltd|