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Alpha-2 Adrenergic Agonist

Clonidine HCl Mucoadhesive Buccal Tablet for Severe Oral Mucositis (VOICE Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by Monopar Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year after the first dose

Awards & highlights

VOICE Trial Summary

This trial is testing whether a new drug can prevent severe mouth sores in patients with cancer in their throat or back of tongue. These patients are receiving radiation therapy, which can cause damage to the surrounding tissues, including the mouth. This damage is called mucositis, and can cause redness, pain, and ulcers in the mouth and throat. It can also make it hard or impossible to eat or drink, which is called severe oral mucositis (SOM). SOM is a frequent and debilitating side effect of chemoradiation that can cause patients to stop treatment, or have other problems like difficulty swallowing. The new drug, cl

Eligible Conditions

Chemoradiotherapy-Induced Severe Oral Mucositis

VOICE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year after the first dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year after the first dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year after the first dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To demonstrate the efficacy of HCl MBT to prevent SOM in OPC patients receiving CRT.

Secondary outcome measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

VOICE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Clonidine HCl Mucoadhesive Buccal Tablet (MBT)Experimental Treatment1 Intervention

Clonidine HCl MBT given daily during chemoradiotherapy

Group II: PlaceboPlacebo Group1 Intervention

Placebo Mucoadhesive Buccal Tablet given daily during chemoradiotherapy

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Who is running the clinical trial?

Monopar TherapeuticsLead Sponsor

2 Previous Clinical Trials

33 Total Patients Enrolled

MazarStudy DirectorChief Scientific Officer

Holli CarlsonStudy DirectorMonopar Therapeutics Inc.

1 Previous Clinical Trials

21 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are part of this clinical research?

"The correct answer is that this study is, as of right now, seeking patients. The trial was first announced on February 11th, 2021 and has been updated as recently as April 12th, 2021. There are 4 sites for this study and 260 total patients needed."

Answered by AI

Are there any other papers that have researched Clonidine HCl Mucoadhesive Buccal Tablet?

"The original study for Clonidine HCl Mucoadhesive Buccal Tablet was done in 1997 at Vanderbilt University Autonomic Dysfunction Center. A total of 108 studies have completed since then, with 23 live studies. The majority of these ongoing trials are based in Cedar Rapids, Iowa."

Answered by AI

Is this particular clinical trial taking place in a high number of hospitals throughout the US?

"There are 4 operating for this trial such as UnityPoint Health (Nassif Community Cancer Center) in Cedar Rapids, Des Moines Oncology Research Association in Des Moines, and IACT Health (John B Amos Cancer Center) in Columbus,to name a few other locations."

Answered by AI

What conditions does Clonidine HCl Mucoadhesive Buccal Tablet typically treat?

"Clonidine HCl Mucoadhesive Buccal Tablet can be used to manage menopausal symptoms, ADHD, and diarrhea in patients with diabetes."

Answered by AI

Are people still signing up for this experiment?

"Yes, this is an active trial that is recruiting patients. The study was first listed on February 11th, 2021 and was most recently updated on April 12th, 2021. The researchers need to find 260 participants total, which will be drawn from 4 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clonidine HCl MBT vs. Placebo to Prevent Chemoradiotherapy-Induced Severe Oral Mucositis in Oropharyngeal Cancer.

2021. "Clonidine HCl MBT vs. Placebo to Prevent Chemoradiotherapy-Induced Severe Oral Mucositis in Oropharyngeal Cancer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04648020.