NCT00637793

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

First QC Date

March 11, 2008

Last Update Submit

January 28, 2009

Conditions

XerostomiaSjogren's Syndrome

Keywords

XerostomiaSjogren's Syndrome

Outcome Measures

Primary Outcomes (1)

  • Quantitative and qualitative assessment of dry mouth

    36 days

Secondary Outcomes (1)

  • Tolerability and safety of NGX267

    36 days

Study Arms (4)

1

PLACEBO COMPARATOR

Placebo capsules

Drug: NGX267

2

EXPERIMENTAL

2 capsules in the am of each treatment period

Drug: NGX267

3

EXPERIMENTAL

2 capsules in the am of each treatment period

Drug: NGX267

4

EXPERIMENTAL

2 capsules in am of each treatment period

Drug: NGX267

Interventions

NGX267DRUG

2 capsules in the am of each treatment period

2

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Penn Rheumatology Associates and Sjogren's Syndrome Center

Philadelphia, Pennsylvania, 19104, United States

Location

Walter F. Chase MD PA

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

XerostomiaSjogren's Syndrome

Interventions

(S)-2-ethyl-8-methyl-1-thia-4,8-diazaspiro(4.5)decan-3-one

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic DiseasesArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 11, 2008

First Posted

March 18, 2008

Study Start

February 1, 2008

Study Completion

November 1, 2008

Last Updated

January 29, 2009

Record last verified: 2009-01

Locations

US(3)