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"Hyaluronan" Formulation for Type 2 Diabetic Patients With Dry Mouth

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ClinicalTrials.gov Identifier: NCT03281486
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
You First Services

Brief Summary:
An increased incidence of dental caries in association with poorly controlled diabetes has also been reported, Xerostomia (dry mouth) has been reported to be a common complaint of patients with diabetes, Without adequate saliva production, both hard and soft tissues of the mouth can be severely damaged and become more susceptible to infections. This 9 week, cross-over group, randomized, single center, study will evaluate the efficacy of HA formulation in alleviating dry mouth in type 2 diabetic patients.

Condition or disease Intervention/treatment Phase
Dry Mouth Xerostomia Type 2 Diabetics Device: HA formulation Oral Spray Device: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Efficacy of "Hyaluronan" Formulation for Dry Mouth in Patients With Type 2 Diabetes
Estimated Study Start Date : January 15, 2018
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

Arm Intervention/treatment
Experimental: HA formulation Oral Spray
Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their assigned mouth spray, 2 times daily (morning and evening), using only the assigned mouth spray provided for the 4 week duration of the study.
Device: HA formulation Oral Spray
It is an HA formulation of FDA listed ingredients

Placebo Comparator: Placebo Oral Spray
Subjects will be instructed to mouth spray with 0.3 ml ( 2 sprays to the mouth) of their assigned mouth spray, 2 times daily (morning and evening), using only the assigned mouth spray provided for the 4 week duration of the study.
Device: Placebo
Placebo formulation without the active ingredients




Primary Outcome Measures :
  1. Relief from drymouth using VAS scoring [ Time Frame: 9 weeks ]
    Patients' perception of efficacy of a new mouth spray for 9 weeks in reducing the symptoms of drymouth in diabetic patients using VAS scoring



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient should be above 18 years of age.
  2. Patients who have been diagnosed with type 2 diabetes and have developed dry mouth or have worsening of pre-existing dry mouth condition.
  3. Ability to attend visits at the research site
  4. Patient should be able to read and/or understand and sign the consent form and be willing to participate in the research study
  5. Agree to abstain from the use of any products for xerostomia other than those provided in the study.
  6. Agree to comply with the conditions and schedule of the study.

Exclusion Criteria:

  1. Subjects with open mouth sores at study entry.
  2. Any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia.
  3. Subjects who are nursing, becoming pregnant or plan to become pregnant during the study period
  4. Subjects currently on medication or treatment for dry mouth/xerostomia
  5. Hypersensitivity to any of the following ingredients- HA ,xylitol and Sodium Benzoate.
  6. Subjects with soft or hard tissue tumor of the oral cavity.
  7. Presence of severe gingivitis.
  8. Chronic disease with concomitant oral manifestations other than xerostomia
  9. History of radiation therapy to head and neck
  10. Subjects with conditions the investigator may feel will interfere with the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281486


Locations
United States, Missouri
Division of Endocrinology and Metabolism, Saint Louis University Recruiting
Saint Louis, Missouri, United States, 63104
Contact: Sandeep Dhindsa, MD    716-598-1544    dhindsa@slu.edu   
Sponsors and Collaborators
You First Services

Responsible Party: You First Services
ClinicalTrials.gov Identifier: NCT03281486     History of Changes
Other Study ID Numbers: LUD-105-17
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents