Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia

Herpes Zoster Clinical Trial

Official title:

Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia and for the Prevention of Post Herpetic Neuralgia- a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03809702
• Other study ID #: BPKoirala
• Status: Completed
• Phase: Phase 4
• Start date: July 15, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: October 2020
• Source: B.P. Koirala Institute of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 30, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Herpes Zoster
• Neuralgia

Intervention

Drug:
• Pregabalin
Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)
• Placebo
Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)

Locations

Country	Name	City	State
Nepal	B P Koirala Institute of Health Sciences	Dharan Bazar	Province 1

Sponsors (2)

Lead Sponsor	Collaborator
B.P. Koirala Institute of Health Sciences	University Grants Commission

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevention of Post Herpetic Neuralgia	Incidence of post herpetic neuralgia in pregabalin group and placebo group	12 months