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Study of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjorgren's Syndrome
This study has been completed.
First Received: March 11, 2008   Last Updated: January 28, 2009   History of Changes
Sponsored by: TorreyPines Therapeutics
Information provided by: TorreyPines Therapeutics
ClinicalTrials.gov Identifier: NCT00637793
  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 II

MedlinePlus related topics: Sjogren's Syndrome
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
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

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
1: Placebo Comparator
Placebo capsules
Drug: NGX267
2 capsules in the am of each treatment period
2: Experimental
2 capsules in the am of each treatment period
Drug: NGX267
2 capsules in the am of each treatment period
3: Experimental
2 capsules in the am of each treatment period
Drug: NGX267
2 capsules in the am of each treatment period
4: Experimental
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
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: TorreyPines Therapeutics, Inc. ( Susan Mellberg, R.N., M.B.A.; VP, Project Management )
Study ID Numbers: NGX267XSS2001
Study First Received: March 11, 2008
Last Updated: January 28, 2009
ClinicalTrials.gov Identifier: NCT00637793     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by TorreyPines Therapeutics:
Xerostomia
Sjogren's Syndrome

Study placed in the following topic categories:
Mouth Diseases
Autoimmune Diseases
Joint Diseases
Eye Diseases
Arthritis, Rheumatoid
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Rheumatic Diseases
Xerostomia
Musculoskeletal Diseases
Sjogren Syndrome
Arthritis
Connective Tissue Diseases
Sjogren's Syndrome
Stomatognathic Diseases
Salivary Gland Diseases

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

ClinicalTrials.gov processed this record on May 07, 2009