Patients with Neuropathic Pain. In the first instance, the investigator will aim to recruit patients with post herpetic neuralgia. If insufficient patients with post herpetic neuralgia are recruited, then patients with painful diabetic neuropathy, small fibre predominant neuropathy and idiopathic sensory neuropathy will also be recruited.
Conditions
Interventions
Trade Name: Arcoxia
Product Name: Arcoxia
Product Code: N/A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Etoricoxib, a COX2 inhibitor
CAS Number: 202409-33-4
Current Sponsor code: MRK0
Sponsors
Analgesic Solutions
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to participate in the study: 1. Be a man or a non-pregnant, non-lactating woman 18 years and older. Women of childbearing potential should be willing to use adequate birth control methods (at the investigator's discretion) during the study to avoid pregnancy 2. Have voluntarily provided written informed consent 3. Be able to speak, read, write, and understand English, understand the consent form, complete study related procedures, and communicate with the study staff 4. Have a clinical diagnosis of PHN by history or objective findings in the opinion of Investigator for a minimum of six months. 5. Have a pain intensity score averaging =3 on a 0-10 NRS for average daily recall over past 24 hours (at Visit 1) 6. 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 profile. Inclusion criteria for enrollment into Double-Blind Period: Have at least a 30% reduction in the average 0-10 NRS pain scores measured over the last seven days prior to Randomization compared to Baseline pain scores (average 0-10 NRS pain scores over the 7-day Baseline Period), and have completed at least 60% of the NRS Pain measurements for each of the 7-day period. Should we decide to expand the recruitment to PDN, ISN, and SFN patients, the inclusion for these patients will be the same as for PHN patients except for inclusion criteria no.4 which will be replaced by the following inclusion criterion: 4. Have a clinical diagnosis of NP (PDN, ISN, or SFN) by history or objective findings in the opinion of the Investigator for a minimum of 6 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not be eligible to participate in the study: 1. Are pregnant and/or lactating 2. Having 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 3. Have evidence for multiple causes of pain in the neuropathic pain area, such as lumbar radiculopathy in an area of lumbosacral PHN 4. Have any bodily moderate to severe pain (e.g. osteoarthritis) that could confound assessment or self-evaluation of pain due to PHN 5. Use NSAID compounds (oral and topical) within 1 week of the study and for the duration of the study; 6. Use opioids including tramadol within 1 week of the 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) 7. Have had neuro-ablation or neurosurgical intervention for their PHN 8. Have received nerve block or intrathecal analgesia within six weeks of study 9. Have a history of congestive heart failure, unstable coronary artery disease, stroke, or uncontrolled hypertension 10. Have a history of significant gastrointestinal disease, including active gastro-duodenal ulcerations, perforations, or bleeds 11. Have abnormal clinical laboratory test results or vital signs unless deemed not clinically significant by the investigator 12. Have skin lesions or damage in the area where BSTK measurements are conducted (only applicable to PHN patients) 13. Are undergoing active treatment for cancer, are known to be infected by HIV, or are being acutely and intensively immunosuppressed following transplantation 14. Have a history of alcohol or other substance abuse (not including nicotine or tobacco) within five years 15. Known to have a condition that in the investigator’s judgement precludes participation in the study 16. Have a significant psychiatric disorder in the opinion of the Investigator 17. Have received an investigational drug or have used an investigational device in the 30 days prior to study entry 18. Have previously been admitted to this study 19. Are allergic to Arcoxia. Should recruitment be expanded to PDN, ISN, and SFN patients, the exclusion criteria for these patients will remain the same.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to measure the efficacy of etoricoxib compared to placebo in reducing pain intensity in patients with neuropathic pain, as measured by Time to Efficacy Failure during the double-blind phase. ;Secondary Objective: The secondary objectives are to: Evaluate the efficacy of etoricoxib in neuropathic pain by: - Mean pain intensity score at bedtime on 0-10 Numerical Rating Scale [NRS] scores captured by Actiwatch - Mean sleep interference score in the morning on 0-10 NRS scores captured by Actiwatch - Mean pain intensity score captured In-Clinic (0-10 NRS) - Patient Global Impression of Change (PGIC) - Brief Pain Intensity-Short Form (BPI-SF) - Activity (actigraphy) measured by Actiwatch) - Pain-activity composite measure - Pain Matching (Pain Matcher) - Pain Quality Assessment Scale (PQAS) - Cumulative distribution for responders - Time to onset of analgesia (in the Open-Label Period only) - Time to dropout for all causes (in the Double-Blind Period only) To examine the Time to Efficacy Failure by PHN subgroup based on sensory testing results. To evaluate the safety and tolerability of etoricoxib in patients with Neuropathic Pain (NP).;Primary end point(s): The primary outcome measure is Time to Efficacy Failure. | — |
Countries
United Kingdom
Outcome results
None listed