Back to resultsEfficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia
Primary Purpose
Herpes Zoster
Status
Completed
Phase
Phase 4
Locations
Nepal
Study Type
Interventional
Intervention
Pregabalin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Herpes Zoster focused on measuring Herpes Zoster, Herpetic neuralgia, Pregabalin
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
Sites / Locations
- B P Koirala Institute of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Pregabalin group
Placebo group
Arm Description
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
Group 2: Placebo tablet twice daily for 4 weeks will be given to the subjects in this group along with other routine treatment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Prevention of Post Herpetic Neuralgia
Incidence of post herpetic neuralgia in pregabalin group and placebo group
Full Information
NCT ID
NCT03809702
First Posted
January 17, 2019
Last Updated
October 13, 2020
Sponsor
B.P. Koirala Institute of Health Sciences
Collaborators
University Grants Commission
1. Study Identification
Unique Protocol Identification Number
NCT03809702
Brief Title
Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia
Official Title
Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia and for the Prevention of Post Herpetic Neuralgia- a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
B.P. Koirala Institute of Health Sciences
Collaborators
University Grants Commission
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster
Keywords
Herpes Zoster, Herpetic neuralgia, Pregabalin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Double blinded randomized controlled trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pregabalin group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Group 2: Placebo tablet twice daily for 4 weeks will be given to the subjects in this group along with other routine treatment
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)
Primary Outcome Measure Information:
Title
Percentage reduction of visual analogue scale (VAS) of pain in each visit in intervention and placebo group
Description
Percentage reduction of visual analogue scale (VAS) of pain in each follow up visits in intervention group as compared to the placebo group
Time Frame
Eight months
Secondary Outcome Measure Information:
Title
Prevention of Post Herpetic Neuralgia
Description
Incidence of post herpetic neuralgia in pregabalin group and placebo group
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suchana Marahatta, MBBS, MD
Organizational Affiliation
B.P. Koirala Institute of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
B P Koirala Institute of Health Sciences
City
Dharān Bāzār
State/Province
Province 1
ZIP/Postal Code
7053
Country
Nepal
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia
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