Clinical trial: Potential of an Experimental Mouthwash Formulation to Reduce Dry Mouth Symptoms (NCT02641912)

Eligibility criteria:
Inclusion Criteria:

          -  Demonstrates understanding of the study procedures, restrictions and willingness to
             participate as evidenced by voluntary written informed consent and has received a
             signed and dated copy of the informed consent form

          -  Good general and mental health with, in the opinion of the investigator or medically
             qualified designee no clinically significant and relevant abnormalities in medical
             history or upon oral examination

          -  Subject with stable and controlled condition with no overt medical conditions which
             would contraindicate participation (in the opinion of the Investigator or medically
             qualified designee) and no clinically significant and relevant abnormalities of
             medical history or oral examination which would interfere with the conduct of the
             study

          -  All subjects should report having a feeling of a dry mouth according to the DMSQ.
             (Subject must answer at least 2 out of the 4 questions with 'agree a little', 'agree'
             or 'strongly agree'

          -  Participation in another clinical study (including cosmetic studies) or receipt of an
             investigational drug within 14 days of the screening visit

          -  Previous participation in this study

          -  Recent history (within the last 1 year) of alcohol or other substance abuse

          -  An employee of the sponsor or the study site or members of their immediate family

          -  Subjects with Sjögren's Syndrome along with reporting having a feeling of dry mouth
             according to the DMSQ, should also have a confirmed diagnosis of their condition as
             shown by a positive salivary gland biopsy or SS-A (anti-Ro antibody) or SS-B (La
             antibody) or a letter from a physician if diagnosis was made more than 3 years ago OR
             Subjects reporting having a feeling of dry mouth due to other diseases or conditions
             excluding Sjögren's Syndrome

          -  Understands and is willing, able and likely to comply with all study procedures and
             restrictions.

        Exclusion Criteria:

          -  Women who are known to be pregnant or who are intending to become pregnant over the
             duration of the study

          -  Women who are breast-feeding

          -  Subject is currently undergoing radiotherapy and/or chemotherapy treatment

          -  Any condition the investigator identifies that can confound the subject's ability to
             properly participate in the study e.g. Alzheimer's Disease

          -  Subjects with untreated oral mucosal disease which in the opinion of the investigator
             could interfere with the study (e.g. current oral ulceration)

          -  Evidence of gross intra-oral neglect or need for extensive dental therapy

             -. Denture wearer (complete dentures)

          -  Subjects not on stable doses of prescription systemic parasympathetic medications
             (e.g. Pilocarpine), for the treatment of the feeling of dry mouth

          -  Known or suspected intolerance or hypersensitivity to the study materials (or closely
             related compounds) or any of their stated ingredients

          -  Participation in another clinical study (including cosmetic studies) or receipt of an
             investigational drug within 14 days of the screening visit

          -  Previous participation in this study

          -  Recent history (within the last 1 year) of alcohol or other substance abuse

          -  An employee of the sponsor or the study site or members of their immediate family
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? Entailment