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NCT00080873 · ClinicalTrials.gov registry record · NA
Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation
A NA study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- NA
- Development phase
- 195
- Enrollment target
NCT00080873: Completed NA study, sponsored by Children's Oncology Group.
NCT00080873 is a NA study that has completed, run by Children's Oncology Group. The registered enrollment target is 195 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00080873, a NA study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- NA
- Development phase
- 195 participants
- Enrollment target
Study Summary
RATIONALE: Traumeel® S (a mouth rinse) may be effective in preventing or decreasing the severity of oral mucositis caused by chemotherapy in young patients who are undergoing stem cell transplantation. PURPOSE: This randomized clinical trial is studying how well Traumeel® S works in preventing or treating mucositis in young patients who are receiving chemotherapy with or without total-body irradiation before undergoing stem cell transplantation.
Primary Outcome
The primary aim of drug efficacy will be measured by the area under the curve (AUC) of the modified Walsh mucositis scale. Scores will be assigned for each region of oral mucosa and totaled for daily score. AUC will be obtained by graphing the total scores recorded every day during follow-up, linking time adjacent points by a straight line and calculating the area under the resulting polygon. The measurement of AUC incorporates both severity and duration of symptoms.
Interventions
- OTHER Placebo
- DRUG Traumeel S
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2004-04 |
| Est. Completion | 2011-01 |
| Phase | NA |
What the finished NCT00080873 record still lists
NCT00080873 is an interventional study that assigns participants to a tested intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00080873 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00080873 about?
NCT00080873 is a clinical study titled "Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation". RATIONALE: Traumeel® S (a mouth rinse) may be effective in preventing or decreasing the severity of oral mucositis caused by chemotherapy in young patients who are undergoing stem cell transplantation. PURPOSE: This randomized clinical trial is studying how well Traumeel® S works in preventing or t...
What is the current status of trial NCT00080873?
This trial is currently completed. It is a NA study. The enrollment target is 195 participants. The study started on 2004-04. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00080873?
The interventions under investigation include: Placebo (OTHER), Traumeel S (DRUG).
Who is sponsoring clinical trial NCT00080873?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00080873's enrollment target sits among peer trials
195 567th of 2000 higher than 1,433 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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