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

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ClinicalTrials.gov Identifier: NCT03120962
Recruitment Status : Not yet recruiting
First Posted : April 19, 2017
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Tracking Information
First Submitted Date  ICMJE April 16, 2017
First Posted Date  ICMJE April 19, 2017
Last Update Posted Date April 19, 2017
Estimated Study Start Date  ICMJE May 2017
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2017)
Proportion of patients with zoster pain. [ Time Frame: 3 months ]
proportion
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2017)
  • Proportion of patients with zoster pain [ Time Frame: 6 months and 1 year ]
    proportion
  • Pain intensity [ Time Frame: 3 days, 7 days, 2 weeks, 3 weeks, 1 month, 3 months and 6 months ]
    0-10 visual analogue scale (VAS; 0 = no pain; 10 = worst possible pain)
  • Quality of life [ Time Frame: 3 days, 7 days, 2 weeks, 3 weeks, 1 month, 3 months and 6 months ]
    zoster brief pain inventory
  • Side-effects [ Time Frame: 3 days, 7 days, 2 weeks, 3 weeks, 1 month, 3 months and 6 months ]
    proportion of side effects
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Early Use of Oxycodone During the Acute Phase of Herpes Zoster on Preventing Postherpetic Neuralgia
Official Title  ICMJE Effect of Early Use of Oxycodone During the Acute Phase of Herpes Zoster on Preventing Postherpetic Neuralgia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Treatment
Condition  ICMJE
  • Herpes Zoster
  • Post-herpetic Neuralgia
Intervention  ICMJE
  • Drug: Oxycodone
    Oxycodone 20mg/day, for 4 weeks
    Other Name: Oxycontin
  • Drug: Gabapentin
    Gabapentin 900mg/day, titrated up to max tolerated dose or 1800mg/day, for 4-12 weeks
    Other Name: neurontin
  • Drug: Famciclovir
    Famciclovir 500mg three-times daily for 7 days
    Other Name: Famvir
Study Arms  ICMJE
  • Experimental: oxycodone
    Oxycodone 20mg/day, for 4 weeks and famciclovir 500mg three-times daily for 7 days.
    Interventions:
    • Drug: Oxycodone
    • Drug: Gabapentin
    • Drug: Famciclovir
  • Active Comparator: standard treatment
    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.
    Interventions:
    • Drug: Gabapentin
    • Drug: Famciclovir
Publications * 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):209-17. doi: 10.1016/j.pain.2008.12.022. Epub 2009 Feb 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2017)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03120962
Other Study ID Numbers  ICMJE 2017-012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor  ICMJE Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP