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NCT00003825 · ClinicalTrials.gov registry record · Phase 3

Pentosan Polysulfate in Treating Patients With Gastrointestinal Disturbance Caused by Radiation Therapy

A Phase 3 study, sponsored by Radiation Therapy Oncology Group.

Completed
Registry status
Phase 3
Development phase
174
Enrollment target

NCT00003825: Completed Phase 3 study, sponsored by Radiation Therapy Oncology Group.

NCT00003825 is a Phase 3 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 174 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00003825, a Phase 3 study, has completed, sponsored by Radiation Therapy Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
174 participants
Enrollment target

Study Summary

RATIONALE: Pentosan polysulfate may be effective in treating side effects of radiation therapy to the abdomen or pelvis. It is not yet known whether pentosan polysulfate is more effective than no further therapy for treating gastrointestinal disturbance caused by previous radiation therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of pentosan polysulfate in treating patients who have inflammation of the rectum, diarrhea, or blood in stools caused by previous radiation therapy to the abdomen and pelvis.

Interventions

  • PROCEDURE quality-of-life assessment
  • DRUG pentosan polysulfate sodium

Trial Details

FieldValue
Enrollment Target 174 participants
Start Date 1999-06
Phase Phase 3
Radiation Therapy Oncology Group

144 total trials

What the finished NCT00003825 record still lists

NCT00003825 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 2 interventions - of which quality-of-life assessment is the first listed.

NCT00003825 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00003825 about?

NCT00003825 is a clinical study titled "Pentosan Polysulfate in Treating Patients With Gastrointestinal Disturbance Caused by Radiation Therapy". RATIONALE: Pentosan polysulfate may be effective in treating side effects of radiation therapy to the abdomen or pelvis. It is not yet known whether pentosan polysulfate is more effective than no further therapy for treating gastrointestinal disturbance caused by previous radiation therapy. PURPOSE...

What is the current status of trial NCT00003825?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 174 participants. The study started on 1999-06.

What interventions are being tested in trial NCT00003825?

The interventions under investigation include: quality-of-life assessment (PROCEDURE), pentosan polysulfate sodium (DRUG).

Who is sponsoring clinical trial NCT00003825?

This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00003825's enrollment target sits among peer trials

174 1442nd of 2000 higher than 556 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00003825, the US trial registry maintained by the National Library of Medicine. NCT00003825 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.