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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etoricoxib | Experimental | 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. |
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| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoricoxib | Drug | 90mg Tablet QD at 10:00a.m. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Efficacy Failure | 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. | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of etoricoxib in NP during the Open-Label and the Double-Blind Periods | 42 Days | |
| Time to efficacy failure by PHN sub-group based on sensory testing results | 42 Days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Cowles, RN | Contact | 781-444-9605 | 121 | kcowles@analgesicsolutions.com |
| Name | Affiliation | Role |
|---|---|---|
| Stuart Ratcliffe, MBChB, MFPM, FRSM | MAC (UK) Neuroscience Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MAC (UK) Neruoscience Ltd | Recruiting | Liverpool | L18 1HQ | United Kingdom |
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| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077613 | Etoricoxib |
| ID | Term |
|---|---|
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
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| Placebo | Drug | One tablet QD at 10:00a.m. |
|
| Safety as assessed by adverse events, serious adverse events, and vital signs |
| 56 Days |
| MAC (UK) Neuroscience Ltd | Recruiting | Manchester | M32 0UT | United Kingdom |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |