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

NCT00637793 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2009-01-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • TorreyPines Therapeutics

    lead INDUSTRY

Principal Investigators

  • Walter F. Chase, M.D. · Walter F. Chase MD. PA

  • Alan Kivitz, M.D. · Altoona Center for Clinical Research

  • Frederick B. Vivino, M.D. · Penn Rheumatology Associates and Sjogren's Syndrome Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Completion
2008-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00637793 on ClinicalTrials.gov