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

Primary Purpose

Postherpetic Neuralgia, Neuralgia

Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Etoricoxib
Placebo
Sponsored by
Analgesic Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postherpetic Neuralgia focused on measuring Postherpetic neuralgia, Neuropathic pain, Etoricoxib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MAC (UK) Neruoscience LtdRecruiting
  • MAC (UK) Neuroscience LtdRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Etoricoxib

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To evaluate the efficacy of etoricoxib in NP during the Open-Label and the Double-Blind Periods
Time to efficacy failure by PHN sub-group based on sensory testing results
Safety as assessed by adverse events, serious adverse events, and vital signs

Full Information

First Posted
December 20, 2010
Last Updated
March 22, 2011
Sponsor
Analgesic Solutions
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01264237
Brief Title
Evaluation of the Efficacy, Tolerability and Safety of Etoricoxib (Arcoxia) in Patients With Neuropathic Pain
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 Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
April 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Analgesic Solutions
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia, Neuralgia
Keywords
Postherpetic neuralgia, Neuropathic pain, Etoricoxib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Etoricoxib
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Etoricoxib
Other Intervention Name(s)
Arcoxia
Intervention Description
90mg Tablet QD at 10:00a.m.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One tablet QD at 10:00a.m.
Primary Outcome Measure Information:
Title
Time to Efficacy Failure
Description
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.
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
To evaluate the efficacy of etoricoxib in NP during the Open-Label and the Double-Blind Periods
Time Frame
42 Days
Title
Time to efficacy failure by PHN sub-group based on sensory testing results
Time Frame
42 Days
Title
Safety as assessed by adverse events, serious adverse events, and vital signs
Time Frame
56 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Cowles, RN
Phone
781-444-9605
Ext
121
Email
kcowles@analgesicsolutions.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Ratcliffe, MBChB, MFPM, FRSM
Organizational Affiliation
MAC (UK) Neuroscience Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
MAC (UK) Neruoscience Ltd
City
Liverpool
ZIP/Postal Code
L18 1HQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart Ratcliffe, MBChB, MFPM, FRSM
Facility Name
MAC (UK) Neuroscience Ltd
City
Manchester
ZIP/Postal Code
M32 0UT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart Ratcliffe, MBChB, MFPM, FRSM

12. IPD Sharing Statement

Learn more about this trial

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

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