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

Sjogren's Syndrome Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Cross Over Study Using a Latin Square Design to Evaluate the Safety, Tolerability, and Efficacy of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjogren's Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637793
• Other study ID #: NGX267XSS2001
• Status: Completed
• Phase: Phase 2
• First received: March 11, 2008
• Last updated: January 28, 2009
• Start date: February 2008
• Est. completion date: November 2008

Study information

• Verified date: January 2009
• Source: TorreyPines Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Syndrome
• Xerostomia

Intervention

Drug:
• NGX267
2 capsules in the am of each treatment period
• NGX267
2 capsules in the am of each treatment period
• NGX267
2 capsules in the am of each treatment period
• NGX267
2 capsules in the am of each treatment period

Locations

Country	Name	City	State
United States	Walter F. Chase MD PA	Austin	Texas
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Penn Rheumatology Associates and Sjogren's Syndrome Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
TorreyPines Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative and qualitative assessment of dry mouth		36 days	No
Secondary	Tolerability and safety of NGX267		36 days	Yes