Efficacy of Pregabalin for the Treatment of Acute Herpeti... | NCT03809702

Studies
Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia

NCT03809702

Sponsor

B.P. Koirala Institute of Health Sciences

Status

Completed

Last Update Posted

Oct 14, 2020Actual

Enrollment

82Actual

Phase

Phase 4

Conditions

Herpes Zoster

Interventions

Pregabalin
Placebo

Countries

Nepal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2018Actual

Primary Completion Date

Sep 20, 2019Actual

Completion Date

Dec 30, 2019Actual

First Submitted Date

Jan 17, 2019

First Submission Date that Met QC Criteria

Jan 17, 2019

First Posted Date

Jan 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2020

Last Update Posted Date

Oct 14, 2020Actual

Name	Class
University Grants Commission	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This study wants to see the role of Pregabalin in acute herpetic neuralgia pain reduction and for the prevention of post herpetic neuralgia incidence as compared to placebo group. For this purpose, all eligible Herpes Zoster patients will be randomized into two groups (41 patients in each group i.e.82 total patients). 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 of pregabalin, control group will receive Placebo. The pain will be evaluated in all patients in each follow visits (weekly follow up for 4 weeks then monthly follow up for next three months). If it is difficult for the patient to present physically, telephonic follow up will be done to find the pain score in the required time. Also, DLQI (Dermatological life quality index) will be assessed at the first and last visit of the patient.

At the end, pain score will be compared between the two groups.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Pregabalin	Drug	Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)	Pregabalin group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Prevention of Post Herpetic Neuralgia	Incidence of post herpetic neuralgia in pregabalin group and placebo group	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Suchana Marahatta, MBBS, MD	B.P. Koirala Institute of Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
B P Koirala Institute of Health Sciences		Dharān	Koshi	7053	Nepal

Condition Browse Module

MeSH Terms

ID	Term
D006562	Herpes Zoster

Ancestor Terms

ID	Term
D000073618	Varicella Zoster Virus Infection
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069583	Pregabalin

Ancestor Terms

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided