NCT03809702

Brief Summary

All eligible Herpes Zoster patients will be randomized into two groups. Group 1 will be the treatment group receiving Pregabalin 75 mg twice daily for 4 weeks in addition to other routine treatment. Whereas, group 2 will be the control group receiving all routine treatment similar to group 1 except Pregabalin. Instead control group will receive Placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

January 17, 2019

Last Update Submit

October 13, 2020

Conditions

Herpes Zoster

Keywords

Herpes ZosterHerpetic neuralgiaPregabalin

Outcome Measures

Primary Outcomes (1)

  • Percentage reduction of visual analogue scale (VAS) of pain in each visit in intervention and placebo group

    Percentage reduction of visual analogue scale (VAS) of pain in each follow up visits in intervention group as compared to the placebo group

    Eight months

Secondary Outcomes (1)

  • Prevention of Post Herpetic Neuralgia

    12 months

Study Arms (2)

Pregabalin group

ACTIVE COMPARATOR

Group 1: Pregabalin tablet 75 mg orally twice daily for 4 weeks will be given to the subjects in this group along with other routine treatment Here, the intervention is administration of Pregabalin tablet 75 mg

Drug: Pregabalin

Placebo group

PLACEBO COMPARATOR

Group 2: Placebo tablet twice daily for 4 weeks will be given to the subjects in this group along with other routine treatment

Drug: Placebo

Interventions

PregabalinDRUG

Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)

Pregabalin group
PlaceboDRUG

Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)

Placebo group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of HZ presenting within 72 hours of onset of rash,
  • With pain score 40 or above on 100 mm pain Visual Analogue Scale at the screening visit,
  • Giving written consent for the study.
  • Age between 18-70 years

You may not qualify if:

  • HZ presenting after 72 hours of onset
  • Pain score less than 40 at baseline
  • Who took the stable doses of oral analgesics like: NSAIDs, acetaminophen, opioids and antidepressant within six hours of screening visit
  • Using Pregabalin and Gabapentin within last 72 hours
  • Nerve block therapy within the last 48 hours
  • History of hypersensitivity to the drug or its ingredients
  • Use of topical medications within 12 hours
  • Unable to come for follow up because of severe systemic illness
  • Significant hepatic and renal disease,
  • Bed ridden patients or those who are physically unfit for follow up visits.
  • Ethically considered vulnerable members- pregnant/lactating mothers/newborn/children below 12 years /physically or mentally challenged individuals/HIV/ AIDS/IV drug users

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

B P Koirala Institute of Health Sciences

Dharān, Koshi, 7053, Nepal

Location

MeSH Terms

Conditions

Herpes Zoster

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Suchana Marahatta, MBBS, MD

    B.P. Koirala Institute of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double blinded randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 18, 2019

Study Start

July 15, 2018

Primary Completion

September 20, 2019

Study Completion

December 30, 2019

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations

NE(1)