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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00637793 |
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Date of registration:
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11/03/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjorgren's Syndrome
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Scientific title:
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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 |
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Date of first enrolment:
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February 2008 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00637793 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Alan Kivitz, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Altoona Center for Clinical Research |
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Name:
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Walter F. Chase, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Walter F. Chase MD. PA |
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Name:
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Frederick B. Vivino, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Penn Rheumatology Associates and Sjogren's Syndrome Center |
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Key inclusion & exclusion criteria
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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.
Age minimum:
21 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Xerostomia
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Sjogren's Syndrome
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Intervention(s)
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Drug: NGX267
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Primary Outcome(s)
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Quantitative and qualitative assessment of dry mouth
[Time Frame: 36 days]
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Secondary Outcome(s)
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Tolerability and safety of NGX267
[Time Frame: 36 days]
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Secondary ID(s)
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NGX267XSS2001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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