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MighTeaFlow, Xylitol

Phase 1

Xerostomia | Unknown | Immunology |GSK plc|Last Updated: Mar 18, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

MighTeaFlow, Xylitol · 1 trial · 3 indications

Phase 1 1
NCT01647737Green Tea Lozenges for the Management of Dry MouthXerostomia
COMPLETED60 Analytics
PHASE1COMPLETED
Green Tea Lozenges for the Management of Dry Mouth
XerostomiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Salivary Flow From Baseline
8 weeks

Change in salivary flow in Xerostomic patients using Green tea lozenges

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MighTeaFlowACTIVE_COMPARATOR4-6 times daily lozenge containing green tea, jaborandi extracts, and 500 mg xylitol for 8 weeks
XylitolACTIVE_COMPARATOR4-6 times daily lozenge containing jaborandi extract, and 500 mg xylitol for 8 weeks

Interventions

NameTypeDescription
MighTeaFlowDIETARY_SUPPLEMENT4-6 times daily
XylitolDIETARY_SUPPLEMENT4-6 times daily
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. A complaint of dry mouth as assessed by a response of 30mm or greater on a Dry Mouth Visual Analog Scale (VAS) 2. Clinical Diagnosis of primary or secondary Sjogren's syndrome. 3. Over the age of 18. 4. Taking less than three drugs associated with causing xerostomia or saliva...

Countries:United States
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Frequently asked questions about MighTeaFlow, Xylitol

What is MighTeaFlow, Xylitol used for?

MighTeaFlow, Xylitol is an investigational drug being studied for the management of xerostomia, commonly known as dry mouth. It is also being evaluated in patients with Sjogren syndrome, a condition that can cause dry mouth. The drug is currently in Phase 1 clinical development.

Who makes MighTeaFlow, Xylitol?

MighTeaFlow, Xylitol is being developed by GSK plc, a global biopharmaceutical company. GSK plc is publicly traded under the ticker symbol GSK on the stock market.

What phase is MighTeaFlow, Xylitol in?

MighTeaFlow, Xylitol is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to evaluate its safety and efficacy.

What clinical trials is MighTeaFlow, Xylitol in?

MighTeaFlow, Xylitol has been studied in one completed clinical trial, identified as NCT01647737, titled "Green Tea Lozenges for the Management of Dry Mouth." This Phase 1 trial enrolled 60 participants with xerostomia, Sjogren syndrome, or dry mouth, and was conducted in the United States.

Is MighTeaFlow, Xylitol the same as Xylitol?

MighTeaFlow, Xylitol is a drug product that contains xylitol as a component, but it is not the same as plain xylitol. The drug is being developed by GSK plc for the management of dry mouth, and it is currently in Phase 1 clinical trials.