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

April 16, 2017 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Oxycontin
Drug: Gabapentin
Gabapentin 900mg/day, titrated up to max tolerated dose or 1800mg/day, for 4-12 weeks
Other Names:
  • neurontin
Drug: Famciclovir
Famciclovir 500mg three-times daily for 7 days
Other Names:
  • 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 Names:
  • neurontin
Drug: Famciclovir
Famciclovir 500mg three-times daily for 7 days
Other Names:
  • Famvir

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with zoster pain.
Time Frame: 3 months
proportion
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with zoster pain
Time Frame: 6 months and 1 year
proportion
6 months and 1 year
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 days, 7 days, 2 weeks, 3 weeks, 1 month, 3 months and 6 months
Quality of life
Time Frame: 3 days, 7 days, 2 weeks, 3 weeks, 1 month, 3 months and 6 months
zoster brief pain inventory
3 days, 7 days, 2 weeks, 3 weeks, 1 month, 3 months and 6 months
Side-effects
Time Frame: 3 days, 7 days, 2 weeks, 3 weeks, 1 month, 3 months and 6 months
proportion of side effects
3 days, 7 days, 2 weeks, 3 weeks, 1 month, 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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