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Evaluation of the Efficacy, Tolerability and Safety of Etoricoxib (Arcoxia) in Patients With Neuropathic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01264237
Recruitment Status : Unknown
Verified March 2011 by Analgesic Solutions.
Recruitment status was:  Recruiting
First Posted : December 21, 2010
Last Update Posted : March 23, 2011
Merck Sharp & Dohme Corp.
Information provided by:
Analgesic Solutions

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Postherpetic Neuralgia Neuralgia Drug: Etoricoxib Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : March 2011
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

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.
Drug: Etoricoxib
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.
Drug: Placebo
One tablet QD at 10:00a.m.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. To evaluate the efficacy of etoricoxib in NP during the Open-Label and the Double-Blind Periods [ Time Frame: 42 Days ]
  2. Time to efficacy failure by PHN sub-group based on sensory testing results [ Time Frame: 42 Days ]
  3. Safety as assessed by adverse events, serious adverse events, and vital signs [ Time Frame: 56 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01264237

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Contact: Karen Cowles, RN 781-444-9605 ext 121

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United Kingdom
MAC (UK) Neruoscience Ltd Recruiting
Liverpool, United Kingdom, L18 1HQ
Principal Investigator: Stuart Ratcliffe, MBChB, MFPM, FRSM         
MAC (UK) Neuroscience Ltd Recruiting
Manchester, United Kingdom, M32 0UT
Principal Investigator: Stuart Ratcliffe, MBChB, MFPM, FRSM         
Sponsors and Collaborators
Analgesic Solutions
Merck Sharp & Dohme Corp.
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Principal Investigator: Stuart Ratcliffe, MBChB, MFPM, FRSM MAC (UK) Neuroscience Ltd

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Responsible Party: Dr Stuart Ratcliffe, MBChB, MFPM, FRSM. Director of Pain Research, MAC UK Neuroscience Ltd Identifier: NCT01264237     History of Changes
Other Study ID Numbers: MRK008b-2010
First Posted: December 21, 2010    Key Record Dates
Last Update Posted: March 23, 2011
Last Verified: March 2011
Keywords provided by Analgesic Solutions:
Postherpetic neuralgia
Neuropathic pain
Additional relevant MeSH terms:
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Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action