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

Primary Purpose

Xerostomia, Sjogren's Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NGX267
NGX267
NGX267
NGX267
Sponsored by
TorreyPines Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerostomia focused on measuring Xerostomia, Sjogren's Syndrome

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Altoona Center for Clinical Research
  • Penn Rheumatology Associates and Sjogren's Syndrome Center
  • Walter F. Chase MD PA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Placebo capsules

2 capsules in the am of each treatment period

2 capsules in the am of each treatment period

2 capsules in am of each treatment period

Outcomes

Primary Outcome Measures

Quantitative and qualitative assessment of dry mouth

Secondary Outcome Measures

Tolerability and safety of NGX267

Full Information

First Posted
March 11, 2008
Last Updated
January 28, 2009
Sponsor
TorreyPines Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00637793
Brief Title
Study of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjorgren's Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
TorreyPines Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia, Sjogren's Syndrome
Keywords
Xerostomia, Sjogren's Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo capsules
Arm Title
2
Arm Type
Experimental
Arm Description
2 capsules in the am of each treatment period
Arm Title
3
Arm Type
Experimental
Arm Description
2 capsules in the am of each treatment period
Arm Title
4
Arm Type
Experimental
Arm Description
2 capsules in am of each treatment period
Intervention Type
Drug
Intervention Name(s)
NGX267
Intervention Description
2 capsules in the am of each treatment period
Intervention Type
Drug
Intervention Name(s)
NGX267
Intervention Description
2 capsules in the am of each treatment period
Intervention Type
Drug
Intervention Name(s)
NGX267
Intervention Description
2 capsules in the am of each treatment period
Intervention Type
Drug
Intervention Name(s)
NGX267
Intervention Description
2 capsules in the am of each treatment period
Primary Outcome Measure Information:
Title
Quantitative and qualitative assessment of dry mouth
Time Frame
36 days
Secondary Outcome Measure Information:
Title
Tolerability and safety of NGX267
Time Frame
36 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter F. Chase, M.D.
Organizational Affiliation
Walter F. Chase MD. PA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan Kivitz, M.D.
Organizational Affiliation
Altoona Center for Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frederick B. Vivino, M.D.
Organizational Affiliation
Penn Rheumatology Associates and Sjogren's Syndrome Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Penn Rheumatology Associates and Sjogren's Syndrome Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Walter F. Chase MD PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States

12. IPD Sharing Statement

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

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