Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial

NCT ID: NCT05245591

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-29
• Study Completion Date: 2029-11-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pentosan Polysulfate Sodium

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.

Group Type: EXPERIMENTAL

Pentosan Polysulfate Sodium 100 MG Oral Capsule

Intervention Type: DRUG

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

Placebo Control

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 100 mg three times daily (tid) for 0-8 weeks Placebo 100 mg twice daily (bid) for 9-16 weeks

Interventions

Pentosan Polysulfate Sodium 100 MG Oral Capsule

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

Intervention Type: DRUG

Placebo

Placebo 100 mg three times daily (tid) for 0-8 weeks Placebo 100 mg twice daily (bid) for 9-16 weeks

Intervention Type: DRUG

Other Intervention Names

Urosan; ELMIRON; PPS

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Patients must be ≥20 years of age

3. Patients must have received definitive radiation therapy for cancer in pelvic area.

4. Time from the end of radiation therapy to radiation cystitis must be longer than 6 months.

5. Radiation cystitis with lower urinary tract symptoms or hematuria.

Exclusion Criteria

1. Abnormal liver function with indication of AST, ALT, or total bilirubin ≥ 1.5 times higher than normal

2. Abnormal renal function with serum creatinine ≥ 1.5 times higher than normal

3. Abnormal coagulation profile with PT/INR higher than normal

4. Thrombocytopenia with platelet counts < 100,000/μL

5. Pregnant or breastfeeding, expecting to pregnancy, or positive for pregnancy test

6. Patients who have systemic inflammatory symptoms during screening period (ie, fever up to 38℃ or WBC counts >12,000/μL)

7. Patients with known urinary tract infection within 6 months of randomization.

8. Any previous intravesical instillation within 6 months of randomization (ie, hyaluronic acid instillation)

9. Any previous hyperbaric oxygen therapy within 6 months of randomization

10. Any previous treatment with pentosan polysulfate sodium within 6 months of randomization

11. Has history of thrombocytopenia, hemophilia or bladder cancer

12. Has known history of Human Immunodeficiency Virus (HIV) or organ transplantation

13. Has known history of drug allergy to pentosan polysulfate sodium

14. Has hematuria caused by clinically active urolithiasis or urothelial carcinoma

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TCM Biotech International Corporation

UNKNOWN

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chao-Yuan Huang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chi-Shin Tseng, MD

Role: CONTACT

clifford1987tcs@gmail.com

+886223123456

Facility Contacts

Chao-Yuan Huang, phD

Role: primary

Other Identifiers

202108161MIPD

Identifier Type: -

Identifier Source: org_study_id