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

NCT03120962 | Unknown DMC

• 1 other identifier: 2017-012
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Herpes Zoster; Post-herpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with zoster pain.

  proportion

  3 months

Secondary Outcomes (4)

• Proportion of patients with zoster pain

  6 months and 1 year

• Pain intensity

  3 days, 7 days, 2 weeks, 3 weeks, 1 month, 3 months and 6 months

• Quality of life

  3 days, 7 days, 2 weeks, 3 weeks, 1 month, 3 months and 6 months

• Side-effects

  3 days, 7 days, 2 weeks, 3 weeks, 1 month, 3 months and 6 months

Study Arms (2)

oxycodone

EXPERIMENTAL

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

Drug: Oxycodone; Drug: Gabapentin; Drug: Famciclovir

standard treatment

ACTIVE COMPARATOR

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; Drug: Famciclovir

Interventions

Oxycodone DRUG

Oxycodone 20mg/day, for 4 weeks

Also known as: Oxycontin

oxycodone

Gabapentin DRUG

Gabapentin 900mg/day, titrated up to max tolerated dose or 1800mg/day, for 4-12 weeks

Also known as: neurontin

oxycodone; standard treatment

Famciclovir DRUG

Famciclovir 500mg three-times daily for 7 days

Also known as: Famvir

oxycodone; standard treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Related Publications (1)

• 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.

  PMID: 19195785 RESULT

MeSH Terms

Conditions

Herpes Zoster; Neuralgia, Postherpetic

Interventions

Oxycodone; Gabapentin; Famciclovir

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Adenine; Purines; Heterocyclic Compounds, 2-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2017
• First Posted: April 19, 2017
• Study Start: May 1, 2017
• Primary Completion: May 1, 2020
• Study Completion: November 1, 2020
• Last Updated: April 19, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share