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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
History of Changes

March 11, 2008
January 28, 2009
February 2008
Not Provided
Quantitative and qualitative assessment of dry mouth [ Time Frame: 36 days ] [ Designated as safety issue: No ]
Quantitative and qualitative assessment of dry mouth [ Time Frame: 36 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00637793 on ClinicalTrials.gov Archive Site
Tolerability and safety of NGX267 [ Time Frame: 36 days ] [ Designated as safety issue: Yes ]
Tolerability and safety of NGX267 [ Time Frame: 36 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Xerostomia
  • Sjogren's Syndrome
Drug: NGX267
2 capsules in the am of each treatment period
  • Placebo Comparator: 1
    Placebo capsules
    Intervention: Drug: NGX267
  • Experimental: 2
    2 capsules in the am of each treatment period
    Intervention: Drug: NGX267
  • Experimental: 3
    2 capsules in the am of each treatment period
    Intervention: Drug: NGX267
  • Experimental: 4
    2 capsules in am of each treatment period
    Intervention: Drug: NGX267
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2008
Not Provided

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.
Both
21 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00637793
NGX267XSS2001
No
Susan Mellberg, R.N., M.B.A.; VP, Project Management, TorreyPines Therapeutics, Inc.
TorreyPines Therapeutics
Not Provided
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
TorreyPines Therapeutics
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP