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

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

Study Overview

• Status: Completed
• Conditions: Sjogren's Syndrome; Xerostomia
• Intervention / Treatment: Drug: NGX267

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Rheumatology Associates and Sjogren's Syndrome Center
  • Texas
    • Austin, Texas, United States, 78705
      • Walter F. Chase MD PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quantitative and qualitative assessment of dry mouth	36 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Tolerability and safety of NGX267	36 days

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: March 11, 2008
• First Submitted That Met QC Criteria: March 11, 2008
• First Posted (Estimate): March 18, 2008

Study Record Updates

• Last Update Posted (Estimate): January 29, 2009
• Last Update Submitted That Met QC Criteria: January 28, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: Xerostomia; Sjogren's Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome; Xerostomia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Cholinergic Agonists; Muscarinic Agonists; (S)-2-ethyl-8-methyl-1-thia-4,8-diazaspiro(4.5)decan-3-one
• Other Study ID Numbers: NGX267XSS2001