Clinical trial: Study of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjorgren's Syndrome (NCT00637793)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 55 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