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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: Completed Phase 2 study of Oral Mucositis and Malignant Tumor of Breast, sponsored by US Oncology Research.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary objective of the study is to determine the incidence of Grade ≥ 2 stomatitis in patients undergoing treatment with an aromatase inhibitor plus everolimus (AIE) when treated with either Miracle Mouthwash (MMW) plus hydrocortisone or with a prednisolone mouth rinse during the first 12 weeks of treatment.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2014-09-04 |
| Est. Completion | 2022-11 |
| Phase | Phase 2 |
What the finished NCT02229136 record still lists
NCT02229136 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 97-participant average among 10 other Oral Mucositis trials with a reported enrollment target.
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02229136's enrollment target sits among peer trials
104 4th of 10 higher than 7 of 10 other Oral Mucositis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oral Mucositis 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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