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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Postherpetic Neuralgia
  • Neuralgia
Primary Contact Details
Recruiting
Recruitment Status
NCT01264237
Primary Trial ID Number
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.
Research Details
    Sorry, this information is not available
Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Etoricoxib, Drug : Placebo

Study Arm Groups : Etoricoxib, Placebo

Intervention Type
See Interventions above
Primary Outcome Measures
  • Time to Efficacy Failure; 28 Days
Secondary Outcome Measures
  • 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; Safety as assessed by adverse events, serious adverse events, and vital signs; 56 Days
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
120
Participant Inclusion 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
GBR002
Manchester
M32 0UT
MAC UK Neuroscience
Liverpool
L18 1HQ
Trial Contact(s)
Primary Trial Contact
Karen Cowles, RN
kcowles@analgesicsolutions.com
121 781-444-9605
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific 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
EudraCT Number
Not available for this trial
Funder(s)
  • Merck Sharp & Dohme Corp.
Other Study ID Numbers
MRK008b-2010
Sponsor(s)
Analgesic Solutions
Key Dates

Recruitment Start Date

Mar 2011

Recruitment End Date

Aug 2011

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

20 Dec 2010

Last Updated

22 Mar 2011