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出境医 / 临床实验 / Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia

Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia

Study Description
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 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 : July 15, 2018
Actual Primary Completion Date : September 20, 2019
Actual Study Completion Date : December 30, 2019
Arms and Interventions
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)

Outcome Measures
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


Eligibility Criteria
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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
Contacts and Locations

Locations
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Nepal
B P Koirala Institute of Health Sciences
Dharān Bāzār, Province 1, Nepal, 7053
Sponsors and Collaborators
B.P. Koirala Institute of Health Sciences
University Grants Commission
Investigators
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Principal Investigator: Suchana Marahatta, MBBS, MD 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 October 14, 2020
Actual Study Start Date  ICMJE July 15, 2018
Actual Primary Completion Date September 20, 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
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 Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2020)
82
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2019)
41
Actual Study Completion Date  ICMJE December 30, 2019
Actual Primary Completion Date September 20, 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 information is only displayed when the study is recruiting subjects
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
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 October 2020

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