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Miracle Mouthwash Plus Hydrocortisone · 1 trial · 4 indications
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.
| Arm | Type | Description |
|---|---|---|
| Miracle Mouthwash plus Hydrocortisone | EXPERIMENTAL | Miracle Mouthwash plus Hydrocortisone, swish and expectorate 10cc (10 mLs) 4 times per day, every day for 12 weeks. |
| Prednisolone | ACTIVE_COMPARATOR | Prednisolone oral solution 15 mg/5 ml; swish and expectorate 10cc (10 mL) 4 times per day, every day for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Miracle Mouthwash Plus Hydrocortisone | DRUG | Miracle Mouthwash Plus Hydrocortisone (16 oz recipe/480 ml) |
| Prednisolone | DRUG | Prednisolone oral solution 15 mg/5 ml |
Inclusion Criteria: 1. Age ≥ 18 years; 2. ECOG (Eastern Cooperative Group) Performance status ≤ 2; 3. Histologic or cytologic confirmation of stage IV hormone receptor-positive breast cancer; 4. Postmenopausal status, defined either by: 1. Age ≥ 55 years and ≥ 1 year of amenorrhea 2. Age \< ...
Miracle Mouthwash Plus Hydrocortisone is an investigational small molecule being studied for the treatment of stomatitis, specifically oral mucositis, in patients with breast cancer. It is being developed by Novartis AG (NVS) and is currently in Phase 2 clinical development.
Miracle Mouthwash Plus Hydrocortisone contains hydrocortisone, a corticosteroid that works by reducing inflammation in the mouth. It is being studied to treat mouth sores caused by everolimus, a cancer therapy, in patients with breast cancer.
Miracle Mouthwash Plus Hydrocortisone is being developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical trials for the treatment of stomatitis.
Miracle Mouthwash Plus Hydrocortisone is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 2 clinical trial has been completed, with 104 female patients enrolled.
Miracle Mouthwash Plus Hydrocortisone has one completed clinical trial, identified as NCT02229136. This Phase 2 study compared Miracle Mouthwash Plus Hydrocortisone to a prednisolone mouth rinse for treating mouth sores caused by everolimus in patients with breast cancer.
No, Miracle Mouthwash Plus Hydrocortisone is not the same as prednisolone mouth rinse. In clinical trial NCT02229136, Miracle Mouthwash Plus Hydrocortisone was compared against a prednisolone mouth rinse as an active control to evaluate its effectiveness in treating mouth sores caused by everolimus.