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Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial

NCT05245591 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-05-04

No results posted yet for this study

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.

Conditions

  • Radiation Cystitis

Interventions

DRUG

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

DRUG

Placebo

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

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

  • TCM Biotech International Corporation

    collaborator UNKNOWN

Principal Investigators

  • Chao-Yuan Huang, MD, PhD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-29
Primary Completion
2024-11-01
Completion
2029-11-01

Countries

  • Taiwan

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05245591 on ClinicalTrials.gov