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

Sponsor

TorreyPines Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00637793

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Xerostomia Sjogren's Syndrome	Drug: NGX267 Drug: NGX267 Drug: NGX267 Drug: NGX267	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Treatment

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

Study Start Date :

Feb 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 Placebo capsules	Drug: NGX267 2 capsules in the am of each treatment period
Experimental: 2 2 capsules in the am of each treatment period	Drug: NGX267 2 capsules in the am of each treatment period
Experimental: 3 2 capsules in the am of each treatment period	Drug: NGX267 2 capsules in the am of each treatment period
Experimental: 4 2 capsules in am of each treatment period	Drug: NGX267 2 capsules in the am of each treatment period

Outcome Measures

Primary Outcome Measures

Quantitative and qualitative assessment of dry mouth [36 days]

Secondary Outcome Measures

Tolerability and safety of NGX267 [36 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

TorreyPines Therapeutics

Investigators

Principal Investigator: Walter F. Chase, M.D., Walter F. Chase MD. PA
Principal Investigator: Alan Kivitz, M.D., Altoona Center for Clinical Research
Principal Investigator: Frederick B. Vivino, M.D., Penn Rheumatology Associates and Sjogren's Syndrome Center