- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01264237
Evaluation of the Efficacy, Tolerability and Safety of Etoricoxib (Arcoxia) in Patients With Neuropathic Pain
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
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Karen Cowles, RN
- Phone Number: 121 781-444-9605
- Email: kcowles@analgesicsolutions.com
Study Locations
-
-
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Liverpool, United Kingdom, L18 1HQ
- Recruiting
- MAC (UK) Neruoscience Ltd
-
Principal Investigator:
- Stuart Ratcliffe, MBChB, MFPM, FRSM
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Manchester, United Kingdom, M32 0UT
- Recruiting
- MAC (UK) Neuroscience Ltd
-
Principal Investigator:
- Stuart Ratcliffe, MBChB, MFPM, FRSM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be a man or a non-pregnant, non-lactating woman 18 years and older. Women of childbearing potential should be willing to use an acceptable birth control method (at the investigator's discretion) during the study to avoid pregnancy.
- Have voluntarily provided written informed consent.
- Be able to speak, read, write, and understand English, understand the consent form, complete study related procedures, and communicate with the study staff.
- Have a clinical diagnosis of PHN by history or objective findings in the opinion of the Investigator for a minimum of 6 months. If the patient pool needs to be expanded to other neuropathic conditions, patients must meet the same criteria of patients with PHN and in addition must have a clinical diagnosis of peripheral diabetic neuropathy (PDN), idiopathic sensory neuropathy (ISN) or small fiber predominant neuropathy (SFN) by history or clinical findings in the opinion of the investigator for a minimum of 6 months.
- Have a pain intensity score averaging ≥3 on a 0-10 NRS for average daily recall over past 24 hours (at Visit 1)
- Be, in the opinion of the investigator, in generally good health (other than PHN) at screening, based upon the results of a medical history, physical examination and laboratory analysis
Exclusion Criteria:
- Are pregnant and/or lactating
- Have been diagnosed as having any inflammatory arthritis, gout, pseudo-gout, Paget's disease, fibromyalgia or any chronic pain syndrome that in the Investigator's opinion would interfere with the assessment of pain and other symptoms of PHN
- Have evidence for multiple causes of pain in the neuropathic pain area, such as lumbar radiculopathy in an area of lumbosacral PHN
- Have any bodily moderate to severe pain (e.g., osteoarthritis) that could confound assessment or self-evaluation of pain due to PHN
- Use NSAID compounds (oral and topical) within 1 week of study and for the duration of the study
- Use opioids including tramadol within 1 week of study and for the duration of the study. (Other NP medications are allowed, provided that the doses have been stable for at least one month prior to Visit 1)
- Have had neuro-ablation or neurosurgical intervention for their PHN
- Have received nerve block or intrathecal analgesia within 6 weeks of study
- Have a history of congestive heart failure, unstable coronary artery disease, stroke, or uncontrolled hypertension
- Have a history of significant gastrointestinal disease, including active gastro-duodenal ulcerations, perforations, or bleeds
- Have abnormal clinical laboratory test results or vital signs unless deemed not clinically significant by the investigator
- Have skin lesions or damage in the area where BSTK measurements are conducted (only applicable to PHN patients)
- Are undergoing active treatment for cancer, are known to be infected by HIV, or are being acutely and intensively immunosuppressed following transplantation
- Have a history of alcohol or other substance abuse (not including nicotine or tobacco) within five years
- Known to have a condition that in the investigator's judgment precludes participation in the study
- Have a significant psychiatric disorder in the opinion of the Investigator.
- Have received an investigational drug or have used an investigational device in the 30 days prior to study entry
- Have previously been admitted to this study
- Are allergic to Arcoxia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Etoricoxib
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 Names:
|
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.
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One tablet QD at 10:00a.m.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Efficacy Failure
Time Frame: 28 Days
|
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
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the efficacy of etoricoxib in NP during the Open-Label and the Double-Blind Periods
Time Frame: 42 Days
|
42 Days
|
Time to efficacy failure by PHN sub-group based on sensory testing results
Time Frame: 42 Days
|
42 Days
|
Safety as assessed by adverse events, serious adverse events, and vital signs
Time Frame: 56 Days
|
56 Days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stuart Ratcliffe, MBChB, MFPM, FRSM, MAC (UK) Neuroscience Ltd
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neuralgia
- Neuralgia, Postherpetic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Etoricoxib
Other Study ID Numbers
- MRK008b-2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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