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Pain, ChronicPhase 1VARICNCT05094414

Using Oral Valacyclovir to Treat Patients With Refractory IC/BPS

A Phase 1 study testing Valacyclovir in people with Pain, Chronic and Urge Incontinence, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a collective term referring to disorders which is characterized by lower urinary tract symptoms, including bladder pain/discomfort, frequent urination without evidence of bacterial infection. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Valacyclovir
Type of treatment
Pill or oral medicine
How many people
30 participants
Where
1 siteTaiwan
Study dates
1 Jul 2021to 30 Apr 2022
Phase
Phase 1
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients with IC/BPS

Who cannot join

  • patients with neurogenic bladder
  • patients with bladder outlet obstruction
  • patients with lymphoma
  • patients with bacteria cystitis

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting

  • Hualien Tzu Chi Hospital

    Hualien City, 970

    Hann-Chorng Kuo, M.D., 886-3-856-1825 ext. 2117, Hck@tzuchi.com.tw

    Jia-Fong Jhang, M.D., +886916958785, alur1984@hotmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: Urology Department, Hualien Tzu Chi Hospital, Hualien, Taiwan

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a collective term referring to disorders which is characterized by lower urinary tract symptoms, including bladder pain/discomfort, frequent urination without evidence of bacterial infection. The etiology of IC/BPS is still uncertain, and most current treatment for IC/BPS are only symptoms control. Our previous study revealed Epstein-Barr virus (EBV) infection presented in the IC/BPS bladders and involved the pathogenesis. Hence, using anti-viral medication valacyclovir for the patients with IC/BPS might have clinical efficacy.

Read the detailed description

We would like to conduct a prospective study to evaluate to therapeutic effect of oral valacyclovir for the patients with IC/BPS. The diagnosis of IC/BPS was made through following the clinical symptom index of the American Urological Association guideline. The IC/BPS patients with concurrent urological diseases, such as neurogenic voiding dysfunction, ketamine cystitis or acute bacterial cystitis in recent one month would be excluded. The IC/BPS patients with possibility of pregnancy also would be rule out.

At first, the enrolled patients would be investigated for urinary analysis and culture to rule out current bacteriuria. The enrolled patients would receive a comprehensive medical history review. A pregnancy test would be performed for women of childbearing potential. The patients would be asked to provide urine sample to urinary virus investigation before the treatment. The IC/BPS patients would be investigated for baseline clinical symptoms questionnaire including VAS, QoL, ICPI, ICSI, and OSS. The parameters in the VUDS report also would be record. The Informed consent would be obtained from all individual participants before the intervention. Due to higher bioavailability, we would use valacyclovir in this study. The dose of valacyclovir we use is according to previous valacyclovir study for genital HSV infection. [18] According previous valacyclovir study for chronic recurrence herpesvirus infection disease, long-term therapy of oral valacyclovir < 1000mg/day should be effective and safe; the safety profiles of valacyclovir and placebo were similar. All of our patients would receive open-label oral valacyclovir 500 mg twice per day for 4 weeks.

We estimate to enroll 30 IC/BPS patients with evidence of EBV infection in bladder into this study. After the beginning of valacyclovir therapy, the patients would receive a telephone interview to evaluated current symptoms changes at first and second weeks. The overall improvement of current therapy would be assessed with Global Response Assessment (GRA) (3: symptoms free, 2: >50% symptoms improvement, 1: 25-50% symptoms improvement, 0: 0-25% symptoms improvement, -1: symptoms worse). The GRA, VAS, and any adverse effect would be investigated in the telephone interview. After the full 4 weeks treatment, the patients would be asked to back to our clinic. All symptoms questionnaire (GRA, VAS, QoL, ICPI, ICSI, and OSS) and adverse effect would be evaluated again. The patients would be asked to provide urine sample again. The primary endpoint of this study is the GRA at 4 weeks. The secondary endpoints include the changes of VAS, VAS, QoL, ICPI, ICSI, and OSS between baseline and end of the study. The following figure showed the study flow diagram.

Being tested
Valacyclovir
Medical subject headings
Chronic Pain, Urinary Incontinence, Urge

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ValacyclovirDrug

    oral valacyclovir 500 mg twice per day for 4 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global Response Assessment (GRA)

    3: symptoms free, 2: >50% symptoms improvement, 1: 25-50% symptoms improvement, 0: 0-25% symptoms improvement, -1: symptoms worse

    Measured: 1 month

Secondary outcomes (2)

  1. VAS

    VAS scale for pain

    Measured: 1 month

  2. OSS

    O'Leary-Sant Symptom Index

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2021
  2. Study start1 Jul 2021
  3. Primary completion28 Feb 2022 (estimated)
  4. Study completion30 Apr 2022 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
The IC/BPS patients would be investigated for baseline clinical symptoms questionnaire including VAS, QoL, ICPI, ICSI, and OSS. All of our patients would receive open-label oral valacyclovir 500 mg twice per day for 4 weeks. We estimate to enroll 30 IC/BPS patients. The overall improvement of current therapy would be assessed with Global Response Assessment (GRA).The GRA, VAS, and any adverse effect would be investigated in the telephone interview. After the full 4 weeks treatment, the patients would be asked to back to our clinic. All symptoms questionnaire (GRA, VAS, QoL, ICPI, ICSI, and OSS) and adverse effect would be evaluated again. The patients would be asked to provide urine sample again. The primary endpoint of this study is the GRA at 4 weeks. The secondary endpoints include the changes of VAS, VAS, QoL, ICPI, ICSI, and OSS between baseline and end of the study.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05094414
Sponsor's protocol ID
MOST 109 2314 B 303 024
Acronym
VARIC
Status last verified
Oct 2021
First submitted
14 Oct 2021
Last updated
26 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kuo HC, Peng CW, Jiang YH, Jhang JF. Urinary Viral Spectrum in Patients with Interstitial Cystitis/Bladder Pain Syndrome and the Clinical Efficacy of Valacyclovir Treatment. Biomedicines. 2024 Feb 26;12(3):522. doi: 10.3390/biomedicines12030522.

    PubMed 38540138

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Valacyclovir in people with Pain, Chronic and Urge Incontinence, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.

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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Oct 2021. 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 Taiwan. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Response Assessment (GRA) (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05094414, which also lists 1 linked publication.

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 26 Oct 2021.

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