Herpes ZosterPhase 4NCT03809702
Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia
A Phase 4 study testing Pregabalin in people with Herpes Zoster, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteNepal
- Study dates
- 15 Jul 2018to 30 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia and for the Prevention of Post Herpetic Neuralgia- a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Herpes Zoster
- Being tested
- Pregabalin, Placebo
- Keywords
- Herpes Zoster, Herpetic neuralgia, Pregabalin
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)
PlaceboDrug
Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin group | Active comparator | 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 Receives: Drug: Pregabalin |
| Placebo group | Placebo comparator | Group 2: Placebo tablet twice daily for 4 weeks will be given to the subjects in this group along with other routine treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction of visual analogue scale (VAS) of pain in each visit in intervention and placebo group
Percentage reduction of visual analogue scale (VAS) of pain in each follow up visits in intervention group as compared to the placebo group
Measured: Eight months
Secondary outcomes (1)
Prevention of Post Herpetic Neuralgia
Incidence of post herpetic neuralgia in pregabalin group and placebo group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start15 Jul 2018
- Primary completion20 Sep 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University Grants Commission
- Responsible party
- Principal investigator, Dr Suchana Marahatta, B.P. Koirala Institute of Health Sciences
- Investigators
- Suchana Marahatta, MBBS, MD, Principal investigator, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809702
- Sponsor's protocol ID
- BPKoirala
- Status last verified
- Oct 2020
- First submitted
- 17 Jan 2019
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia and for the Prevention of Post Herpetic Neuralgia- a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03809702
- Acronym / sponsor ID
- BPKoirala
- Conditions
- Herpes Zoster
- Keywords
- Herpes Zoster, Herpetic neuralgia, Pregabalin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Collaborators
- University Grants Commission
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Pregabalin group | Active comparator | Drug: PregabalinGroup 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 |
| Placebo group | Placebo comparator | Drug: PlaceboGroup 2: Placebo tablet twice daily for 4 weeks will be given to the subjects in this group along with other routine treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinPain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group) | Drug | Pregabalin group |
| PlaceboPain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group) | Drug | Placebo group |
Primary outcome
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
1 secondary outcome
Prevention of Post Herpetic Neuralgia
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suchana Marahatta, MBBS, MD principal investigator
B.P. Koirala Institute of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin in people with Herpes Zoster, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage reduction of visual analogue scale (VAS) of pain in each visit in intervention and placebo group (time frame: Eight months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.