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

NCT ID: NCT00637793

Last Updated: 2009-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2008-11-30

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

Conditions

Xerostomia; Sjogren's Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Placebo capsules

Group Type: PLACEBO_COMPARATOR

NGX267

Intervention Type: DRUG

2 capsules in the am of each treatment period

2

2 capsules in the am of each treatment period

Group Type: EXPERIMENTAL

NGX267

Intervention Type: DRUG

2 capsules in the am of each treatment period

3

2 capsules in the am of each treatment period

Group Type: EXPERIMENTAL

NGX267

Intervention Type: DRUG

2 capsules in the am of each treatment period

4

2 capsules in am of each treatment period

Group Type: EXPERIMENTAL

NGX267

Intervention Type: DRUG

2 capsules in the am of each treatment period

Interventions

NGX267

2 capsules in the am of each treatment period

Intervention Type: DRUG

NGX267

2 capsules in the am of each treatment period

Intervention Type: DRUG

NGX267

2 capsules in the am of each treatment period

Intervention Type: DRUG

NGX267

2 capsules in the am of each treatment period

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TorreyPines Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

TorreyPines Therapeutics, Inc.

Principal Investigators

Walter F. Chase, M.D.

Role: PRINCIPAL_INVESTIGATOR

Walter F. Chase MD. PA

Alan Kivitz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Altoona Center for Clinical Research

Frederick B. Vivino, M.D.

Role: PRINCIPAL_INVESTIGATOR

Penn Rheumatology Associates and Sjogren's Syndrome Center

Locations

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Penn Rheumatology Associates and Sjogren's Syndrome Center

Philadelphia, Pennsylvania, United States

Walter F. Chase MD PA

Austin, Texas, United States

Countries

United States

Other Identifiers

NGX267XSS2001

Identifier Type: -

Identifier Source: org_study_id