MucoPEG for Dry Mouth

(CEMPEG Trial)

No longer recruiting at 1 trial location

Overseen By Jamie L Seifert

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SunBio, Inc.

Must not be taking: Parasympathetic medications

Disqualifiers: Pregnancy, Breastfeeding, Radiotherapy, Chemotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of two oral rinses, MucoPEG™ and Biotene®, for individuals with dry mouth (xerostomia). Participants will use one rinse for two weeks, take a break, and then switch to the other rinse for another two weeks. The study seeks to determine which rinse better relieves dry mouth symptoms. Individuals experiencing dry mouth with noticeable dryness may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance dry mouth treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain medications for dry mouth with unstable doses.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that MucoPEG™ is designed to help with dry mouth, also known as xerostomia. While specific safety data from research articles is unavailable, MucoPEG™ contains polyethylene glycol (PEG), a substance commonly used in many products and generally considered safe.

Biotene® is another option, a well-known mouth rinse for dry mouth relief that has been available for a long time and is usually well-tolerated.

Both treatments aim to relieve dry mouth and contain ingredients considered safe, making them likely to be well-tolerated by study participants. As always, those considering joining a trial should discuss any concerns with the trial coordinators or their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

MucoPEG™ is unique because it offers a new approach to managing xerostomia, or dry mouth, by focusing on enhancing moisture retention in the oral cavity. Unlike current treatments like Biotene, which primarily aim to provide temporary relief, MucoPEG™ utilizes a novel polymer technology designed to mimic the natural lubricating properties of saliva. Researchers are excited about this treatment because it has the potential to offer longer-lasting comfort and improve the quality of life for people suffering from dry mouth.

What evidence suggests that this trial's treatments could be effective for dry mouth?

Research has shown that MucoPEG™ might help treat dry mouth by increasing comfort and reducing dryness. In this trial, participants will receive either MucoPEG™ or Biotene® to compare their effectiveness in relieving dry mouth symptoms.

Biotene® is already known to alleviate dry mouth by adding moisture and providing relief. Users of Biotene® have reported reduced dryness, making it a trusted choice for many.

This trial tests both MucoPEG™ and Biotene® to evaluate their ability to reduce dryness and enhance comfort in the mouth. ^{2 3 4 6 7}

Who Is on the Research Team?

To be determined To be determined, DDS

Principal Investigator

Study Site

Are You a Good Fit for This Trial?

Inclusion Criteria

Participant agrees not to eat, drink, chew tobacco, chew gum, smoke, brush or floss their teeth for 2 hours prior to study visits

Participant agrees not to use any oral care products or any type of breath mint or lozenges for 2 hours prior to study visits

Participant with a Challacombe Scale score of 1 or higher

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive either MucoPEG™ or Biotene® oral rinse twice a day for two weeks

2 weeks

2 visits (in-person)

Wash-out

Participants undergo a wash-out period before switching treatments

1 week

Treatment Period 2

Participants switch to the other oral rinse and use it twice a day for two weeks

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Biotene
• MucoPEG

How Is the Trial Designed?

Group I: MucoPEG Experimental Treatment 1 Intervention

Arm being compared to against Biotene

Group II: Biotene Active Control 1 Intervention

Arm being compared against MucoPEG

Who Is Running the Clinical Trial?

SunBio, Inc.

Lead Sponsor

Trials

1

Recruited

40+

Rudacure

Industry Sponsor

Trials

1

Recruited

40+

NAMSA

Collaborator

Trials

55

Recruited

21,500+

Published Research Related to This Trial

The 4th Annual European Biosafe meeting highlighted significant challenges in non-clinical safety testing of biopharmaceuticals, particularly regarding immune activation and the complexities of innovative therapies like CAR-T cells.

Discussions emphasized the importance of using pharmacokinetic and pharmacodynamic data to optimize toxicology study designs, which can improve human risk assessments for these advanced therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonclinical safety testing of biopharmaceuticals--Addressing current challenges of these novel and emerging therapies. Brennan, FR., Baumann, A., Blaich, G., et al.[2015]

The EU council directives provide a comprehensive regulatory framework to ensure the safety of biotechnological medicinal products, focusing on benefit/risk evaluation and quality assessment.

The framework emphasizes the importance of preclinical safety and efficacy testing before new drug applications are approved, ensuring that new treatments are both safe and effective for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of biotechnological products. Bass, R., Purves, J., Amati, MP.[2019]

The BIOBADASER III registry, initiated in December 2015, includes data from 2,664 patients with rheumatic diseases treated with biological or synthetic drugs, focusing on tracking adverse events and treatment effectiveness.

In the first year, the most common adverse events reported were infections and infestations, highlighting the need for ongoing monitoring of safety in patients undergoing long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objectives and methodology of BIOBADASER phase iii. Sanchez-Piedra, C., Hernández Miguel, MV., Manero, J., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04986501

Clinical Evaluation of MucoPEG™ for Xerostomia The study will gather data on patient reported outcomes on the safety and performance of the product, mouth-feel qualities and any changes in dry mouth.

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/01/NCT04986501/Prot_000.pdf

Protocol Title Clinical Evaluation of MucoPEG™ for ... This study will also gather data on patient reported outcomes on the safety and performance of the product, mouth-feel qualities and any ...

3. withpower.com withpower.com/trial/phase-xerostomia-6-2021-bc906

Clinical Evaluation of MucoPEG™ for Xerostomia ... This trial is testing two different mouth rinses, MucoPEG™ and Biotene®, to see which one works better for people with dry mouth.

4. goodday.health goodday.health/trials/4986501

Clinical Evaluation of MucoPEG™ for Xerostomia - GoodDay The purpose of this study is to evaluate the effectiveness of the oral rinse comparing to MucoPEG™ and Biotene®. This is a randomized open-label crossover study ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/01/NCT04986501/SAP_001.pdf

SunBio Inc. Clinical Evaluation of MucoPEG for Xerostomia ... Interval estimation will be carried out using an exact method for binomial outcomes and the objective will be met if the lower limit of a 90% ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K190144.pdf

November 5, 2019 SunBio, Inc. Stuart Goldman Sr. Consultant ... MucoPEG™ is an artificial saliva to relieve xerostomia symptoms and discomfort. The main ingredient of. MucoPEG™ is a polyethylene glycol (PEG) ...

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0038951

Dry Mouth (DBCOND0038951) Associated Data ; Pilocarpine. A muscarinic agonist used to treat dry mouth and various ophthalmic conditions, such as presbyopia, increased intraocular pressure ...