Clinical trial: A Safety and Efficacy Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's Syndrome (NCT00852839)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female, aged 18 to 80 years (inclusive), and capable of providing their
             written informed consent.

          -  Male subjects must be either not sexually active, surgically sterilized, or agree to
             use an appropriate "double-barrier" method during study participation and for at least
             30 days after the completion of dosing.

          -  Non-pregnant female subjects must be either not sexually active, post-menopausal,
             surgically sterilized; or agree to use an appropriate "double-barrier" method; or are
             currently using a prescribed transdermal, injection, implant, or oral contraceptive
             for at least 30 days before study participation and at least 30 days after the
             completion of dosing.

          -  Good health, as determined by a medical history, a physical examination, a detailed
             oral examination, 12-lead ECG, and measurement of clinical chemistry, hematology,
             urinalysis, and serology data.

          -  Demonstrated minimal level of unstimulated whole mouth salivary flow (greater than or
             equal to 0.05 milliliters [ie, 0.05 grams] per 5 minutes).

          -  Demonstrated clinically significant, moderate to severe level of dry mouth at
             screening as determined by his/her score on a 100-mm global VAS of dry mouth symptoms
             with anchors ranging from 'not dry at all' (0) to 'dry as a desert' (100) as follows:

          -  Minimal VAS score of 50 mm at Visit 1.

          -  Diagnosis of primary Sjögren's syndrome.

        Exclusion Criteria:

          -  Currently using a potassium-sparing diuretic antihypertensive drug that contains
             amiloride; spironolactone (e.g.,Aldactone, Novo-Spiroton, Spiractin, Spirtone,
             Verospiron or Berlactone); triamterene (e.g., Dyrenium); or plerenone (e.g., Inspra).
             Chronic use antihistamines will be permitted if started at least 30 days before Visit
             1, and a stable dose is maintained throughout the trial.

          -  Started using systemic cholinergic secretagogues or tricyclic antidepressant drugs
             within 12 weeks before screening, is not on a stable dosing regimen for at least 14
             days prior to the Screening visit, or who is unable to maintain stable dosing
             throughout the study.

          -  Unable to withhold the use of oral comfort agents (eg, Oasis, MouthKote, etc)
             following enrollment in the study (Visit 1).

          -  Shows evidence of a significant active or ongoing oral infection or other oral
             conditions (eg, lichen planus) that, in the opinion of the Investigator, might affect
             the safety of the subject or be exacerbated during study participation.

          -  Acutely infected salivary glands or suspected closure of the salivary glands.

          -  A condition that may confound the diagnosis of primary Sjögren's syndrome.

          -  Received an investigational drug within the past 30 days.

          -  Received 552-02 in a previous study.

          -  History of multiple drug allergies or allergy to any medicine chemically related to
             the study drug (eg, amiloride, Moduretic, Midamor, triamterene).

          -  Any clinically significant allergic disease, including food allergies, with the
             exception of nonactive hayfever.

          -  Present history of any clinically significant and uncontrolled neurologic,
             gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic,
             endocrine, or hematological disorder or disease, or any other major disorder or
             disease, in the opinion of the Investigator.

          -  Sitting blood pressure at screening higher than 150/90 mmHg or lower than 100/50 mmHg
             after resting for 5 minutes.

          -  Sitting pulse rate at screening outside the range of 50 - 90 beats per minute (bpm)
             after resting for 5 minutes.

          -  Consumes more than 2 alcoholic drinks per day or has a significant history of
             alcoholism or drug/chemical abuse within the past 12 months.

          -  History of using tobacco products within the last 3 months.

          -  Has viral hepatitis or tests positively for the hepatitis B surface antigen (HBsAg) or
             hepatitis C (non-A, non-B) antibody, or a positive result for human immunodeficiency
             virus (HIV) antibodies.

          -  Positive serum pregnancy test or is nursing (female subjects only).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 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? Contradiction