search
Back to results

Effect of Early Use of Oxycodone During the Acute Phase of Herpes Zoster on Preventing Postherpetic Neuralgia

Primary Purpose

Herpes Zoster, Post-herpetic Neuralgia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oxycodone
Gabapentin
Famciclovir
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Zoster

Eligibility Criteria

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

Inclusion Criteria:

Provide written informed consent. Male or female patients of 50 years of age and older. Diagnosis of uncomplicated herpes zoster presenting within the first 7 days of vesicles.

Average pain score pre-therapy greater or equal than 4 on a 0-10 visual analogue scale (VAS; 0 = no pain; 10 = worst possible pain).

Exclusion Criteria:

Patients with a history of chronic pain. Patients with immune dysfunction including congenital immune deficiency, active malignancy of any type, collagen vascular diseases, organ or bone marrow transplantations, known infection with HIV or severe atopic dermatitis.

Patients who have received cytotoxic drugs or immunosuppressive therapy (e.g., chronic systemic corticosteroids) within the previous 3 months.

Patients who have received systemic anti-VZV medications or immunomodulatory medications (including interferon) within the previous 4 weeks.

Patients with impaired renal function: calculated creatinine clearance of <30 mL/min using Cockcroft and Gault formula.

Patients with abnormal liver function (alanine transaminase (ALT) or aspartate;transaminase (AST) levels greater than five times the upper limit of the normal range).

Patients with a history of intolerance or hypersensitivity to acyclovir, penciclovir, valacyclovir, famciclovir, gabapentin or oxycodone.

Patients with alcohol or drug abuse history within the previous 5 years. Patients currently receiving therapy with opioid analgesics or tramadol. Patients currently receiving therapy with gabapentin or tricyclic antidepressants.

Pregnant females and nursing mothers.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    oxycodone

    standard treatment

    Arm Description

    Oxycodone 20mg/day, for 4 weeks and famciclovir 500mg three-times daily for 7 days.

    Gabapentin 900mg/day, titrated up to max tolerated dose or 1800mg/day (whichever is lower), for 4-12 weeks and famciclovir 500mg three-times daily for 7 days.

    Outcomes

    Primary Outcome Measures

    Proportion of patients with zoster pain.
    proportion

    Secondary Outcome Measures

    Proportion of patients with zoster pain
    proportion
    Pain intensity
    0-10 visual analogue scale (VAS; 0 = no pain; 10 = worst possible pain)
    Quality of life
    zoster brief pain inventory
    Side-effects
    proportion of side effects

    Full Information

    First Posted
    April 16, 2017
    Last Updated
    April 16, 2017
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03120962
    Brief Title
    Effect of Early Use of Oxycodone During the Acute Phase of Herpes Zoster on Preventing Postherpetic Neuralgia
    Official Title
    Effect of Early Use of Oxycodone During the Acute Phase of Herpes Zoster on Preventing Postherpetic Neuralgia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2017 (Anticipated)
    Primary Completion Date
    May 2020 (Anticipated)
    Study Completion Date
    November 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Postherpetic neuralgia (PHN) which persists more than 90 days after the resolution of the acute shingles episode is the most common complication of herpes zoster. The continued pain or paresthesia not only affects patient quality of life, but also causes physical disability, emotional distress and social isolation. Conventional treatments for PHN are only partially work in some patients or not work at all in others. Once PHN presences, it is often refractory to the treatment, therefore, it is important to prevent the occurrence of PHN. In the study, the investigators want to identift whether the additional use of oxycodone therapy to current standard treatment in acute herpes zoster patients will decrease the incidence of post-herpetic neuralgia.
    Detailed Description
    Herpes zoster (HZ) results from reactivation of the latent varicella zoster virus in sensory ganglia, with characteristic symptom of painful skin rash and localized blisters. Usually, the rash heals and pain resolves within two to four weeks, but in some patients the pain continues to persist for more than 90 days after the onset of rash, which is known as postherpetic neuralgia (PHN). PHN is the most common complication of HZ. Depending on the definition, the incidence of HZ patients developing PHN varied from approximately 5% to 30%. The continued pain or paresthesia not only affects patient quality of life, but also causes physical disability, emotional distress and social isolation. Conventional treatments for PHN include topical lidocaine or capsaicin, anticonvulsants, tricyclic antidepressants, and opioids. However, whether prescribed alone or in combination, these medications are only partially work in some patients or not work at all in others. Once PHN presences, it is often refractory to the treatment, therefore, it is important to prevent the occurrence of PHN. Previous studies have identified age, rash duration before consultation, presence of severe rash and acute pain severity as predictors of increased PHN risk. Thus, the treatment of acute pain of herpes zoster has the potential to prevent the development of PHN. Acute zoster pain represents a combination of nociceptive and neuropathic pain which can be relieved by oxycodone. However, it is not known whether the additional use of oxycodone therapy to current standard treatment in acute herpes zoster patients will decrease the incidence of post-herpetic neuralgia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Herpes Zoster, Post-herpetic Neuralgia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Masking Description
    Open Label
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    oxycodone
    Arm Type
    Experimental
    Arm Description
    Oxycodone 20mg/day, for 4 weeks and famciclovir 500mg three-times daily for 7 days.
    Arm Title
    standard treatment
    Arm Type
    Active Comparator
    Arm Description
    Gabapentin 900mg/day, titrated up to max tolerated dose or 1800mg/day (whichever is lower), for 4-12 weeks and famciclovir 500mg three-times daily for 7 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Oxycodone
    Other Intervention Name(s)
    Oxycontin
    Intervention Description
    Oxycodone 20mg/day, for 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Gabapentin
    Other Intervention Name(s)
    neurontin
    Intervention Description
    Gabapentin 900mg/day, titrated up to max tolerated dose or 1800mg/day, for 4-12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Famciclovir
    Other Intervention Name(s)
    Famvir
    Intervention Description
    Famciclovir 500mg three-times daily for 7 days
    Primary Outcome Measure Information:
    Title
    Proportion of patients with zoster pain.
    Description
    proportion
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Proportion of patients with zoster pain
    Description
    proportion
    Time Frame
    6 months and 1 year
    Title
    Pain intensity
    Description
    0-10 visual analogue scale (VAS; 0 = no pain; 10 = worst possible pain)
    Time Frame
    3 days, 7 days, 2 weeks, 3 weeks, 1 month, 3 months and 6 months
    Title
    Quality of life
    Description
    zoster brief pain inventory
    Time Frame
    3 days, 7 days, 2 weeks, 3 weeks, 1 month, 3 months and 6 months
    Title
    Side-effects
    Description
    proportion of side effects
    Time Frame
    3 days, 7 days, 2 weeks, 3 weeks, 1 month, 3 months and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Provide written informed consent. Male or female patients of 50 years of age and older. Diagnosis of uncomplicated herpes zoster presenting within the first 7 days of vesicles. Average pain score pre-therapy greater or equal than 4 on a 0-10 visual analogue scale (VAS; 0 = no pain; 10 = worst possible pain). Exclusion Criteria: Patients with a history of chronic pain. Patients with immune dysfunction including congenital immune deficiency, active malignancy of any type, collagen vascular diseases, organ or bone marrow transplantations, known infection with HIV or severe atopic dermatitis. Patients who have received cytotoxic drugs or immunosuppressive therapy (e.g., chronic systemic corticosteroids) within the previous 3 months. Patients who have received systemic anti-VZV medications or immunomodulatory medications (including interferon) within the previous 4 weeks. Patients with impaired renal function: calculated creatinine clearance of <30 mL/min using Cockcroft and Gault formula. Patients with abnormal liver function (alanine transaminase (ALT) or aspartate;transaminase (AST) levels greater than five times the upper limit of the normal range). Patients with a history of intolerance or hypersensitivity to acyclovir, penciclovir, valacyclovir, famciclovir, gabapentin or oxycodone. Patients with alcohol or drug abuse history within the previous 5 years. Patients currently receiving therapy with opioid analgesics or tramadol. Patients currently receiving therapy with gabapentin or tricyclic antidepressants. Pregnant females and nursing mothers.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19195785
    Citation
    Dworkin RH, Barbano RL, Tyring SK, Betts RF, McDermott MP, Pennella-Vaughan J, Bennett GJ, Berber E, Gnann JW, Irvine C, Kamp C, Kieburtz K, Max MB, Schmader KE. A randomized, placebo-controlled trial of oxycodone and of gabapentin for acute pain in herpes zoster. Pain. 2009 Apr;142(3):209-217. doi: 10.1016/j.pain.2008.12.022. Epub 2009 Feb 4.
    Results Reference
    result

    Learn more about this trial

    Effect of Early Use of Oxycodone During the Acute Phase of Herpes Zoster on Preventing Postherpetic Neuralgia

    We'll reach out to this number within 24 hrs