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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

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.

Condition or disease Intervention/treatment Phase
Herpes Zoster Post-herpetic Neuralgia Drug: Oxycodone Drug: Gabapentin Drug: Famciclovir Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: Effect of Early Use of Oxycodone During the Acute Phase of Herpes Zoster on Preventing Postherpetic Neuralgia
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: oxycodone
Oxycodone 20mg/day, for 4 weeks and famciclovir 500mg three-times daily for 7 days.
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

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.
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




Primary Outcome Measures :
  1. Proportion of patients with zoster pain. [ Time Frame: 3 months ]
    proportion


Secondary Outcome Measures :
  1. Proportion of patients with zoster pain [ Time Frame: 6 months and 1 year ]
    proportion

  2. 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)

  3. Quality of life [ Time Frame: 3 days, 7 days, 2 weeks, 3 weeks, 1 month, 3 months and 6 months ]
    zoster brief pain inventory

  4. Side-effects [ Time Frame: 3 days, 7 days, 2 weeks, 3 weeks, 1 month, 3 months and 6 months ]
    proportion of side effects



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Publications of Results:
Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03120962     History of Changes
Other Study ID Numbers: 2017-012
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Herpes Zoster
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Oxycodone
Gabapentin
Famciclovir
2-Aminopurine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents