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Sponsored by: |
TorreyPines Therapeutics |
---|---|
Information provided by: | TorreyPines Therapeutics |
ClinicalTrials.gov Identifier: | NCT00637793 |
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 |
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 |
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
|
Ages Eligible for Study: | 21 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
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 |
Xerostomia Sjogren's Syndrome |
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 |
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 |