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

This study has been completed.
Sponsor:
Information provided by:
TorreyPines Therapeutics
ClinicalTrials.gov Identifier:
NCT00637793
First received: March 11, 2008
Last updated: January 28, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Xerostomia
Sjogren's Syndrome
Drug: NGX267
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by TorreyPines Therapeutics:

Primary Outcome Measures:
  • Quantitative and qualitative assessment of dry mouth [ Time Frame: 36 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability and safety of NGX267 [ Time Frame: 36 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: February 2008
Study Completion Date: November 2008
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637793

Locations
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Penn Rheumatology Associates and Sjogren's Syndrome Center
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
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
  More Information

No publications provided

Responsible Party: Susan Mellberg, R.N., M.B.A.; VP, Project Management, TorreyPines Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00637793     History of Changes
Other Study ID Numbers: NGX267XSS2001
Study First Received: March 11, 2008
Last Updated: January 28, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by TorreyPines Therapeutics:
Xerostomia
Sjogren's Syndrome

Additional relevant MeSH terms:
Sjogren's Syndrome
Syndrome
Xerostomia
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Disease
Dry Eye Syndromes
Eye Diseases
Immune System Diseases
Joint Diseases
Lacrimal Apparatus Diseases
Mouth Diseases
Musculoskeletal Diseases
Pathologic Processes
Rheumatic Diseases
Salivary Gland Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 29, 2014