Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant

NCT01305200 · View on ClinicalTrials.gov ↗

Study Summary

This randomized phase III trial is studying how well Caphosol rinse works in preventing mucositis in young patients undergoing autologous or donor stem cell transplant. Supersaturated calcium phosphate (Caphosol) rinse may be able to prevent mucositis, or mouth sores, in patients undergoing stem cell transplant.

Interventions

  • OTHER placebo
  • OTHER questionnaire administration
  • PROCEDURE quality-of-life assessment
  • DRUG supersaturated calcium phosphate rinse

Study Locations (20)

California

  • Children's Oncology Group — Arcadia
  • City of Hope — Duarte
  • Children's Hospital and Research Center at Oakland — Oakland
  • Rady Children's Hospital - San Diego — San Diego
  • University of California San Francisco Medical Center-Parnassus — San Francisco

Florida

  • Miami Children's Hospital — Miami
  • All Children's Hospital — St. Petersburg

Illinois

  • Lurie Children's Hospital-Chicago — Chicago
  • University of Chicago — Chicago

Massachusetts

  • Floating Hospital for Children at Tufts Medical Center — Boston
  • Dana-Farber Cancer Institute — Boston

Delaware

  • Alfred I duPont Hospital for Children — Wilmington

District of Columbia

  • Children's National Medical Center — Washington D.C.

Georgia

  • Children's Healthcare of Atlanta - Egleston — Atlanta

Indiana

  • Riley Hospital for Children — Indianapolis

Trial Details

FieldValue
Enrollment Target 226 participants
Start Date 2011-03
Est. Completion 2015-06-30
Phase Phase 3

Sponsor

Children's Oncology Group

318 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01305200

The ClinicalTrials.gov registry entry for NCT01305200 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 226 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Chronic Myelomonocytic Leukemia appearing as the primary indexed condition, and to 4 interventions — of which placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01305200 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01305200 about?

NCT01305200 is a clinical study titled "Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant". This randomized phase III trial is studying how well Caphosol rinse works in preventing mucositis in young patients undergoing autologous or donor stem cell transplant. Supersaturated calcium phosphate (Caphosol) rinse may be able to prevent mucositis, or mouth sores, in patients undergoing stem cel...

What is the current status of trial NCT01305200?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 226 participants. The study started on 2011-03. Estimated completion is 2015-06-30.

What conditions does trial NCT01305200 study?

This clinical trial studies the following conditions: Chronic Myelomonocytic Leukemia, Juvenile Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Myelodysplastic Syndromes. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01305200?

The interventions under investigation include: placebo (OTHER), questionnaire administration (OTHER), quality-of-life assessment (PROCEDURE), supersaturated calcium phosphate rinse (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01305200?

This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01305200 being conducted?

This trial has 20 study locations across California, Delaware, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial