Radiation CystitisPhase 2/3NCT05245591
Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial
A Phase 2/3 study testing Pentosan Polysulfate Sodium 100 MG Oral Capsule in people with Radiation Cystitis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of pentosan polysulfate sodium versus placebo and in patients with radiation cystitis who have received radiation therapy in pelvic region. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Radiation Cystitis
- What is being tested?
- Pentosan Polysulfate Sodium 100 MG Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Apr 2022to 1 Nov 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the study protocol.
- Patients must be ≥20 years of age
- Patients must have received definitive radiation therapy for cancer in pelvic area.
- Time from the end of radiation therapy to radiation cystitis must be longer than 6 months.
- Radiation cystitis with lower urinary tract symptoms or hematuria.
Who cannot join
- Abnormal liver function with indication of AST, ALT, or total bilirubin ≥ 1.5 times higher than normal
- Abnormal renal function with serum creatinine ≥ 1.5 times higher than normal
- Abnormal coagulation profile with PT/INR higher than normal
- Thrombocytopenia with platelet counts < 100,000/μL
- Pregnant or breastfeeding, expecting to pregnancy, or positive for pregnancy test
- Patients who have systemic inflammatory symptoms during screening period (ie, fever up to 38℃ or WBC counts >12,000/μL)
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- Patients with known urinary tract infection within 6 months of randomization.
- Any previous intravesical instillation within 6 months of randomization (ie, hyaluronic acid instillation)
- Any previous hyperbaric oxygen therapy within 6 months of randomization
- Any previous treatment with pentosan polysulfate sodium within 6 months of randomization
- Has history of thrombocytopenia, hemophilia or bladder cancer
- Has known history of Human Immunodeficiency Virus (HIV) or organ transplantation
- Has known history of drug allergy to pentosan polysulfate sodium
- Has hematuria caused by clinically active urolithiasis or urothelial carcinoma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Chao-Yuan Huang, phD
About this study
Official title: A Randomized, Controlled, Phase II/III Trial to Evaluate the Efficacy and Safety of U101 Oral Capsules in Radiation-induced Cystitis
The purpose of this study is to evaluate the efficacy and safety of pentosan polysulfate sodium versus placebo and in patients with radiation cystitis who have received radiation therapy in pelvic region.
Read the detailed description
RCT-PPS is a phase II/III study evaluating the efficacy, safety, and tolerability of pentosan polysulfate sodium (PPS) versus placebo to patients with radiation cystitis who have received radiation therapy in pelvic region.
Approximately 72 patients were planned to be randomized in RCT-PPS trial in a 1:1 ratio to treatment with either PPS or placebo. Patients will receive oral treatment with 16 weeks (PPS 100mg three times a day for 8 weeks and then with PPS 100mg twice daily for another 8 weeks).
- Conditions
- Radiation Cystitis
- Being tested
- Pentosan Polysulfate Sodium 100 MG Oral Capsule, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentosan Polysulfate Sodium 100 MG Oral CapsuleDrug
Also called Urosan, ELMIRON, PPS
Pentosan Polysulfate Sodium 100 mg three times daily (tid) for 0-8 weeks Pentosan Polysulfate Sodium 100 mg twice daily (bid) for 9-16 weeks
PlaceboDrug
Placebo 100 mg three times daily (tid) for 0-8 weeks Placebo 100 mg twice daily (bid) for 9-16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pentosan Polysulfate Sodium | Experimental | U101 is available as a capsule containing 100 milligrams (mg) of pentosan polysulfate sodium. Subjects will be administered U101 at a dose of 300 milligrams (mg) three times daily (tid) for the initial 8 weeks and then 200 milligrams (mg) twice daily (bid) for another 8 weeks during the study. Receives: Drug: Pentosan Polysulfate Sodium 100 MG Oral Capsule |
| Placebo Control | Placebo comparator | Placebo to match U101 is available as a capsule in 100 milligrams (mg). Subjects will be administered placebo at a dose of 300 milligrams (mg) three times daily (tid) for the initial 8 weeks and then 200 milligrams (mg) twice daily (bid) for another 8 weeks during the study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete remission in lower urinary tract symptoms and hematuria
Number of participants without lower urinary tract symptoms and hematuria assessed by ESOU 2019 and CTCAE v5.0
Measured: From date of randomization throughout the treatment period up to 5 years
Time to complete remission
Time from randomization to complete remission of lower urinary tract syndromes and hematuria
Measured: From date of randomization to study completion up to 5 years
Time to hematuria recurrence
Time from randomization to recurrence of hematuria
Measured: From date of randomization to study completion up to 5 years
Assessment of quality of life
Functional Assessment of 36-Item Short Form Survey (SF-36)
Measured: From date of randomization to study completion up to 5 years
Assessment of symptoms
Functional Assessment of Expanded Prostate Cancer Index Composite-26 (EPIC-26)
Measured: From date of randomization to study completion up to 5 years
Secondary outcomes (3)
Duration of hospitalization
Overall days of hospitalization due to radiation cystitis
Measured: From date of randomization to study completion up to 5 years
Number of invasive procedures
Percentage of patients underwent transurethral cauterization of bladder bleeders or transurethral clots evacuation.
Measured: From date of randomization to study completion up to 5 years
Number of adverse events
Percentage of patients with any adverse event (AE), adverse event (AE) leading to study drug discontinuation, serious adverse event (SAE), and adverse event (AE) related to study drug.
Measured: From date of randomization to study completion up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start29 Apr 2022
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation CystitisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TCM Biotech International Corporation
- Responsible party
- Sponsor
- Investigators
- Chao-Yuan Huang, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245591
- Sponsor's protocol ID
- 202108161MIPD
- Status last verified
- Jan 2022
- First submitted
- 23 Jan 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Phase II/III Trial to Evaluate the Efficacy and Safety of U101 Oral Capsules in Radiation-induced Cystitis
- ClinicalTrials.gov ID
- NCT05245591
- Acronym / sponsor ID
- 202108161MIPD
- Conditions
- Radiation Cystitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- TCM Biotech International Corporation
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 18 Feb 2022 (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.
The purpose of this study is to evaluate the efficacy and safety of pentosan polysulfate sodium versus placebo and in patients with radiation cystitis who have received radiation therapy in pelvic region.
Detailed description
RCT-PPS is a phase II/III study evaluating the efficacy, safety, and tolerability of pentosan polysulfate sodium (PPS) versus placebo to patients with radiation cystitis who have received radiation therapy in pelvic region.
Approximately 72 patients were planned to be randomized in RCT-PPS trial in a 1:1 ratio to treatment with either PPS or placebo. Patients will receive oral treatment with 16 weeks (PPS 100mg three times a day for 8 weeks and then with PPS 100mg twice daily for another 8 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentosan Polysulfate Sodium | Experimental | Drug: Pentosan Polysulfate Sodium 100 MG Oral CapsuleU101 is available as a capsule containing 100 milligrams (mg) of pentosan polysulfate sodium. Subjects will be administered U101 at a dose of 300 milligrams (mg) three times daily (tid) for the initial 8 weeks and then 200 milligrams (mg) twice daily (bid) for another 8 weeks during the study. |
| Placebo Control | Placebo comparator | Drug: PlaceboPlacebo to match U101 is available as a capsule in 100 milligrams (mg). Subjects will be administered placebo at a dose of 300 milligrams (mg) three times daily (tid) for the initial 8 weeks and then 200 milligrams (mg) twice daily (bid) for another 8 weeks during the study. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the study protocol.
- Patients must be ≥20 years of age
- Patients must have received definitive radiation therapy for cancer in pelvic area.
- Time from the end of radiation therapy to radiation cystitis must be longer than 6 months.
- Radiation cystitis with lower urinary tract symptoms or hematuria.
Key exclusion criteria (14 listed)
- Abnormal liver function with indication of AST, ALT, or total bilirubin ≥ 1.5 times higher than normal
- Abnormal renal function with serum creatinine ≥ 1.5 times higher than normal
- Abnormal coagulation profile with PT/INR higher than normal
- Thrombocytopenia with platelet counts < 100,000/μL
- Pregnant or breastfeeding, expecting to pregnancy, or positive for pregnancy test
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 |
|---|---|---|
| Pentosan Polysulfate Sodium 100 MG Oral CapsuleAlso: Urosan, ELMIRON, PPSPentosan Polysulfate Sodium 100 mg three times daily (tid) for 0-8 weeks Pentosan Polysulfate Sodium 100 mg twice daily (bid) for 9-16 weeks | Drug | Pentosan Polysulfate Sodium |
| PlaceboPlacebo 100 mg three times daily (tid) for 0-8 weeks Placebo 100 mg twice daily (bid) for 9-16 weeks | Drug | Placebo Control |
Primary outcome
Rate of complete remission in lower urinary tract symptoms and hematuria
Time frame: From date of randomization throughout the treatment period up to 5 years
Number of participants without lower urinary tract symptoms and hematuria assessed by ESOU 2019 and CTCAE v5.0
Time to complete remission
Time frame: From date of randomization to study completion up to 5 years
Time from randomization to complete remission of lower urinary tract syndromes and hematuria
Time to hematuria recurrence
Time frame: From date of randomization to study completion up to 5 years
Time from randomization to recurrence of hematuria
Assessment of quality of life
Time frame: From date of randomization to study completion up to 5 years
Functional Assessment of 36-Item Short Form Survey (SF-36)
Assessment of symptoms
Time frame: From date of randomization to study completion up to 5 years
Functional Assessment of Expanded Prostate Cancer Index Composite-26 (EPIC-26)
3 secondary outcomes
Duration of hospitalization
Time frame: From date of randomization to study completion up to 5 years
Number of invasive procedures
Time frame: From date of randomization to study completion up to 5 years
Number of adverse events
Time frame: From date of randomization to study completion up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: No
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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.
Chao-Yuan Huang, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pentosan Polysulfate Sodium 100 MG Oral Capsule in people with Radiation Cystitis, run by National Taiwan University 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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 4 May 2022. 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. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi-Shin Tseng, MD (+886223123456, clifford1987tcs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complete remission in lower urinary tract symptoms and hematuria (time frame: From date of randomization throughout the treatment period up to 5 years). The study lists 5 primary outcomes in all. 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 4 May 2022.