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NCT02229136 · ClinicalTrials.gov registry record · Phase 2

Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus

A Phase 2 study of Oral Mucositis and Malignant Tumor of Breast, sponsored by US Oncology Research.

Completed
Registry status
Phase 2
Development phase
104
Enrollment target
1
Study location

NCT02229136 is a Phase 2 study of Oral Mucositis and Malignant Tumor of Breast that has completed, run by US Oncology Research. The registered enrollment target is 104 participants, roughly in line with the 97-participant average among 10 other Oral Mucositis trials with a reported enrollment target. The trial reports 1 study location across 1 state.

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The verdict

NCT02229136, a Phase 2 study of Oral Mucositis and Malignant Tumor of Breast, has completed, sponsored by US Oncology Research.

COMPLETED
Registry status
Phase 2
Development phase
104 participants
Enrollment target
1
Study location

Study Summary

This is a randomized Phase 2 study to evaluate two different steroid-based mouth rinses (Miracle Mouth Wash plus hydrocortisone versus prednisolone oral rinse) for the prevention or treatment of everolimus-associated stomatitis (mouth sores) in postmenopausal patients undergoing treatment with an aromatase inhibitor plus everolimus. An exploratory analysis will also evaluate patient response to next anti-cancer therapy of physician's choice following discontinuation of therapy with an aromatase inhibitor plus everolimus.

Interventions

  • DRUG Prednisolone
  • DRUG Miracle Mouthwash Plus Hydrocortisone

Study Locations (1)

Texas

  • 12 sites incl Yakima, WA, Boulder, CO, and Austin, TX - US

Trial Details

FieldValue
Enrollment Target 104 participants
Start Date 2014-09-04
Est. Completion 2022-11
Phase Phase 2

Sponsor

US Oncology Research

27 total trials

What the Registry Record Tells You About NCT02229136

The ClinicalTrials.gov registry entry for NCT02229136 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 97-participant average among 10 other Oral Mucositis trials with a reported enrollment target. The listed sponsor is US Oncology Research, which has 27 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Oral Mucositis appearing as the primary indexed condition, and to 2 interventions - of which Prednisolone is the first listed.

NCT02229136 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT02229136 about?

NCT02229136 is a clinical study titled "Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus". This is a randomized Phase 2 study to evaluate two different steroid-based mouth rinses (Miracle Mouth Wash plus hydrocortisone versus prednisolone oral rinse) for the prevention or treatment of everolimus-associated stomatitis (mouth sores) in postmenopausal patients undergoing treatment with an ar...

What is the current status of trial NCT02229136?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2014-09-04. Estimated completion is 2022-11.

What conditions does trial NCT02229136 study?

This clinical trial studies the following conditions: Oral Mucositis, Malignant Tumor of Breast, Stomatitis, Neoplasm of the Breast.

What interventions are being tested in trial NCT02229136?

The interventions under investigation include: Prednisolone (DRUG), Miracle Mouthwash Plus Hydrocortisone (DRUG).

Who is sponsoring clinical trial NCT02229136?

This trial is sponsored by US Oncology Research, which has 27 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02229136 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.