Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia

B.P. Koirala Institute of Health Sciences

Status and phase: Completed; Phase 4

Conditions: Herpes Zoster

Treatments: Drug: Pregabalin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03809702

BPKoirala

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups, including a placebo group

Pregabalin group

Active Comparator group

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

Treatment:

Drug: Pregabalin

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo