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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Analgesic Solutions.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Analgesic Solutions
ClinicalTrials.gov Identifier:
NCT01264237
First received: December 20, 2010
Last updated: March 22, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Postherpetic Neuralgia
Neuralgia
Drug: Etoricoxib
Drug: Placebo
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Analgesic Solutions:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264237

Contacts
Contact: Karen Cowles, RN 781-444-9605 ext 121 kcowles@analgesicsolutions.com

Locations
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.
Investigators
Principal Investigator: Stuart Ratcliffe, MBChB, MFPM, FRSM MAC (UK) Neuroscience Ltd
  More Information

No publications provided

Responsible Party: Dr Stuart Ratcliffe, MBChB, MFPM, FRSM. Director of Pain Research, MAC UK Neuroscience Ltd
ClinicalTrials.gov Identifier: NCT01264237     History of Changes
Other Study ID Numbers: MRK008b-2010
Study First Received: December 20, 2010
Last Updated: March 22, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Analgesic Solutions:
Postherpetic neuralgia
Neuropathic pain
Etoricoxib

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014