Condition or disease | Intervention/treatment | Phase |
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Herpes Zoster | Drug: Pregabalin Drug: Placebo | Phase 4 |
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 : | 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 |
Arm | Intervention/treatment |
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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
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Drug: Pregabalin
Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)
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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
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Drug: Placebo
Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)
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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 |
Inclusion Criteria:
Exclusion Criteria:
Nepal | |
B P Koirala Institute of Health Sciences | |
Dharān Bāzār, Province 1, Nepal, 7053 |
Principal Investigator: | Suchana Marahatta, MBBS, MD | B.P. Koirala Institute of Health Sciences |
Tracking Information | |||||
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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 |
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
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Original Primary Outcome Measures ICMJE |
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
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
Prevention of Post Herpetic Neuralgia [ Time Frame: 12 months ] Incidence of post herpetic neuralgia in pregabalin group and placebo group
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Original Secondary Outcome Measures ICMJE |
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
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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. |
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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 |
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Condition ICMJE | Herpes Zoster | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
82 | ||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |
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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 |