NCT03708653

Brief Summary

Postherpetic neuralgia (PHN) is a common condition and affecting 5 to 30% of the herpes zoster patients. In some cases, the pain remained refractory after first and second line treatment for herpes zoster. This suggests that there may be genetic variants that make some patients susceptible to PHN. Using saliva samples from herpes zoster patients the investigators are going to analyze the relationship between single nucleotide polymorphisms (SNPs) in genes that are known to be involved in pain and PHN.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2019

Completed
Last Updated

April 23, 2019

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

September 5, 2018

Last Update Submit

April 21, 2019

Conditions

Postherpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

  • correlation between pain SNPs and PHN

    At Enrollment

Study Arms (2)

PHN(+)

Patients who have persistent pain more than three months after the onset of herpes zoster.

PHN(-)

Patients whose pain disappear within three months.

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Herpes zoster patients in a large university hospital

You may qualify if:

  • Age more than 50 years
  • Clinically defined herpes zoster patients

You may not qualify if:

  • Patients not able to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva

MeSH Terms

Conditions

Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

NeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Min Yan, Doctor

    Zhejiang University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2018

First Posted

October 17, 2018

Study Start

April 1, 2018

Primary Completion

February 13, 2019

Study Completion

February 13, 2019

Last Updated

April 23, 2019

Record last verified: 2018-09

Locations

CN(1)