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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

Tracking Information
First Submitted Date  ICMJE January 17, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date January 18, 2019
Actual Study Start Date  ICMJE October 4, 2018
Estimated Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
To evaluate the efficacy of Pregabalin in patients with acute Herpetic pain - Percentage reduction of visual analogue scale (VAS) of pain [ Time Frame: Eight months ]
Percentage reduction of visual analogue scale (VAS) of pain in acute herpetic neuralgia in pregabalin group compared to the placebo group
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
Prevention of Post Herpetic Neuralgia [ Time Frame: 12 months ]
Incidence of post herpetic neuralgia in pregabalin group and placebo group
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
To assess the role of Pregabalin for the prevention of Post Herpetic Neuralgia - Incidence of post herpetic neuralgia [ Time Frame: 12 months ]
Incidence of post herpetic neuralgia will be compared between pregabalin and placebo group
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia
Official Title  ICMJE Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia and for the Prevention of Post Herpetic Neuralgia- a Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Double blinded randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Herpes Zoster
Intervention  ICMJE
  • Drug: Pregabalin
    Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)
  • Drug: Placebo
    Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)
Study Arms  ICMJE
  • 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
    Intervention: Drug: Pregabalin
  • 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
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 17, 2019)
41
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2019
Estimated Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Suchana Marahatta, MBBS, MD 977-9862023236 dermasuchana@gmail.com, suchanamarahatta@yahoo.com
Listed Location Countries  ICMJE Nepal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809702
Other Study ID Numbers  ICMJE BPKoirala
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Suchana Marahatta, B.P. Koirala Institute of Health Sciences
Study Sponsor  ICMJE B.P. Koirala Institute of Health Sciences
Collaborators  ICMJE University grants commission, Nepal (Funding source)
Investigators  ICMJE
Principal Investigator: Suchana Marahatta, MBBS, MD B.P. Koirala Institute of Health Sciences
PRS Account B.P. Koirala Institute of Health Sciences
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP