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

NCT01264237 | Unknown Phase 4 DMC

• 1 other identifier: MRK008b-2010
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Postherpetic Neuralgia; Neuralgia

Keywords

Postherpetic neuralgia; Neuropathic pain; Etoricoxib

Outcome Measures

Primary Outcomes (1)

• Time to Efficacy Failure

  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 Outcomes (3)

• 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

Study Arms (2)

Etoricoxib

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Etoricoxib DRUG

90mg Tablet QD at 10:00a.m.

Also known as: Arcoxia

Etoricoxib

Placebo DRUG

One tablet QD at 10:00a.m.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Analgesic Solutions: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

MAC (UK) Neruoscience Ltd

Liverpool, L18 1HQ, United Kingdom

RECRUITING

MAC (UK) Neuroscience Ltd

Manchester, M32 0UT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neuralgia, Postherpetic; Neuralgia

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stuart Ratcliffe, MBChB, MFPM, FRSM

  MAC (UK) Neuroscience Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Cowles, RN

CONTACT

781-444-9605; kcowles@analgesicsolutions.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 21, 2010
• Study Start: March 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: April 1, 2012
• Last Updated: March 23, 2011

Record last verified: 2011-03

Locations

GB (2)