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Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia

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ClinicalTrials.gov Identifier: NCT03809702
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Collaborator:
University grants commission, Nepal (Funding source)
Information provided by (Responsible Party):
Dr Suchana Marahatta, B.P. Koirala Institute of Health Sciences

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.

Condition or disease Intervention/treatment Phase
Herpes Zoster Drug: Pregabalin Drug: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blinded randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia and for the Prevention of Post Herpetic Neuralgia- a Randomized Controlled Trial
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
Drug Information available for: Pregabalin

Arm Intervention/treatment
Active Comparator: Pregabalin group
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
Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Prevention of Post Herpetic Neuralgia [ Time Frame: 12 months ]
    Incidence of post herpetic neuralgia in pregabalin group and placebo group



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809702


Contacts
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Contact: Suchana Marahatta, MBBS, MD 977-9862023236 dermasuchana@gmail.com, suchanamarahatta@yahoo.com

Locations
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Nepal
B P Koirala Institute of Health Sciences Recruiting
Dharān Bāzār, Province 1, Nepal, 7053
Contact: Ashish Ghimire, MBBS, MD    977-9842053079    ashishghimi@gmail.com   
Sponsors and Collaborators
B.P. Koirala Institute of Health Sciences
University grants commission, Nepal (Funding source)
Investigators
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Principal Investigator: Suchana Marahatta, MBBS, MD B.P. Koirala Institute of Health Sciences

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Responsible Party: Dr Suchana Marahatta, Associate Professor, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT03809702     History of Changes
Other Study ID Numbers: BPKoirala
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Suchana Marahatta, B.P. Koirala Institute of Health Sciences:
Herpes Zoster
Herpetic neuralgia
Pregabalin

Additional relevant MeSH terms:
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Neuralgia
Herpes Zoster
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs