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Completed

NCT Number: NCT03809702

Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

B P Koirala Institute of Health Sciences

Dharān, Koshi, 7053, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: Eight months

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

Secondary outcomes

  1. Prevention of Post Herpetic Neuralgia

    Time frame: 12 months

    Incidence of post herpetic neuralgia in pregabalin group and placebo group

Sponsors and collaborators

Lead sponsor

B.P. Koirala Institute of Health Sciences

Other

Collaborators

  • University Grants Commission

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2019
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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