NCT00637793

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: TorreyPines Therapeutics · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

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

Conditions

• Xerostomia
• Sjogren's Syndrome

Interventions

Type	Name	Description
DRUG	NGX267	2 capsules in the am of each treatment period
DRUG	NGX267	2 capsules in the am of each treatment period
DRUG	NGX267	2 capsules in the am of each treatment period
DRUG	NGX267	2 capsules in the am of each treatment period

Timeline

• Start date: 2008-02-01
• Completion: 2008-11-01
• First posted: 2008-03-18
• Last updated: 2009-01-29

Locations

3 sites across 1 country: United States