Status:
COMPLETED
Study of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjorgren's Syndrome
Lead Sponsor:
TorreyPines Therapeutics
Conditions:
Xerostomia
Sjogren's Syndrome
Eligibility:
All Genders
21-55 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effectiveness of NGX267 in the improvement of decreased salivary flow associated with primary or secondary Sjögren's syndrome. For each patient, the study...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00637793
Start Date
February 1 2008
End Date
November 1 2008
Last Update
January 29 2009
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
2
Penn Rheumatology Associates and Sjogren's Syndrome Center
Philadelphia, Pennsylvania, United States, 19104
3
Walter F. Chase MD PA
Austin, Texas, United States, 78705