Study of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjorgren's Syndrome

Inclusion criteria

• Males and females aged 21 to 55 years, diagnosed with primary or secondary Sjögren's syndrome.
• Patients with a complaint of dry mouth based upon difficulty in speaking, swallowing, a sensation of mouth or throat dryness, lip or tongue dryness, or a level of thirst of sufficient intensity for the patient to seek therapy.
• Females of childbearing potential must not be at risk for pregnancy during the study. Females not of childbearing potential include postmenopausal and women who have been surgically sterilized.
• Patients must not be in an acute phase of illness.

Exclusion criteria

• Patients who have clinically significant reduction kidney function. cardiovascular abnormalities; lymphoma secondary to Sjögren's syndrome; pulmonary disease; the presence of enlarged salivary glands; physical closure of the salivary gland or known surgical procedure on the lacrimal punctum.
• Patients with diagnoses of a current gastrointestinal (GI) disease that would be exacerbated by the use of cholinomimetics; a current and acute psychiatric disorder, acute iritis, narrow angle glaucoma, or retinal disease as determined by medical history and physical examination.
• Patients who are otherwise judged inappropriate for inclusion in the study by the investigator
• Patients who have received any experimental drugs or devices or participated in any clinical trial within 30 days prior to screening including participation in a previous NGX267 clinical trial.
• Patients who are allergic to compounds that are similar to NGX267.