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

Phase 2

Completed

• Conditions: Xerostomia; Sjogren's Syndrome
• Interventions: Drug: NGX267

• Registration Number: NCT00637793
• Lead Sponsor: TorreyPines Therapeutics

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 includes four periods of treatment separated by a washout period that may range from 4 - 8 days according to patient and site discretion. Each treatment period includes two overnight stays in the clinic. One dose of study drug is taken during each treatment period

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-11
• Study First Submitted QC: 2008-03-11
• Study First Posted: 2008-03-18
• Study Completion: 2008-11
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-28
• Last Update Posted: 2009-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	NGX267	Placebo capsules
2	NGX267	2 capsules in the am of each treatment period
3	NGX267	2 capsules in the am of each treatment period
4	NGX267	2 capsules in am of each treatment period

Primary Outcome Measures

Name	Time	Method
Quantitative and qualitative assessment of dry mouth	36 days

Secondary Outcome Measures

Name	Time	Method
Tolerability and safety of NGX267	36 days

Trial Locations

Locations (3)

Penn Rheumatology Associates and Sjogren's Syndrome Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Altoona Center for Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Walter F. Chase MD PA; 🇺🇸 Austin, Texas, United States