A Safety and Efficacy Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren'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).