A Safety and Efficacy Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's Syndrome

September 12, 2018 updated by: Parion Sciences

A Randomized, Double-Blind, Vehicle-Controlled, Parallel Arm Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's Syndrome

This clinical study is to determine whether daily administration of a formulation of 552-02 improves the dry mouth condition in subjects with primary Sjögren's syndrome.

Study Overview

Detailed Description

The primary objective of this clinical study is to determine whether daily administration of an oromucosal formulation of 552-02 improves the global assessment of dry mouth, as assessed by visual analog scale (VAS), in subjects with primary Sjögren's syndrome.

The secondary objectives of this study are as follows:

  • To evaluate the safety of daily administration of an oromucosal formulation of 552-02 in subjects with primary Sjögren's syndrome.
  • To evaluate whether administration of an oromucosal formulation of 552-02 improves the subjective measurement of 6 different salivary functions, as measured using VAS, in subjects with primary Sjögren's syndrome.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Connecticut
      • Trumbull, Connecticut, United States, 06611
        • New England Research Associates, LLC
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida College of Dentristy
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana School of Dentristy
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • The Center for Rheumatology and Bone Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts University School of Dental Medicine
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • Rochester, New York, United States, 14518
        • AAIR Research Center
    • North Carolina
      • Charlotte, North Carolina, United States, 26232
        • Carolinas Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center For Clinical Research
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Rheumatology Associates
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Rheumatology Consultants
    • Texas
      • Dallas, Texas, United States, 75246
        • Arthritis Centers of Texas
      • San Antonio, Texas, United States, 78229
        • Univ. of Texas Health Science Center
    • Washington
      • Spokane, Washington, United States, 99204
        • Arthritis Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, aged 18 to 80 years (inclusive), and capable of providing their written informed consent.
  • Male subjects must be either not sexually active, surgically sterilized, or agree to use an appropriate "double-barrier" method during study participation and for at least 30 days after the completion of dosing.
  • Non-pregnant female subjects must be either not sexually active, post-menopausal, surgically sterilized; or agree to use an appropriate "double-barrier" method; or are currently using a prescribed transdermal, injection, implant, or oral contraceptive for at least 30 days before study participation and at least 30 days after the completion of dosing.
  • Good health, as determined by a medical history, a physical examination, a detailed oral examination, 12-lead ECG, and measurement of clinical chemistry, hematology, urinalysis, and serology data.
  • Demonstrated minimal level of unstimulated whole mouth salivary flow (greater than or equal to 0.05 milliliters [ie, 0.05 grams] per 5 minutes).
  • Demonstrated clinically significant, moderate to severe level of dry mouth at screening as determined by his/her score on a 100-mm global VAS of dry mouth symptoms with anchors ranging from 'not dry at all' (0) to 'dry as a desert' (100) as follows:
  • Minimal VAS score of 50 mm at Visit 1.
  • Diagnosis of primary Sjögren's syndrome.

Exclusion Criteria:

  • Currently using a potassium-sparing diuretic antihypertensive drug that contains amiloride; spironolactone (e.g.,Aldactone, Novo-Spiroton, Spiractin, Spirtone, Verospiron or Berlactone); triamterene (e.g., Dyrenium); or plerenone (e.g., Inspra). Chronic use antihistamines will be permitted if started at least 30 days before Visit 1, and a stable dose is maintained throughout the trial.
  • Started using systemic cholinergic secretagogues or tricyclic antidepressant drugs within 12 weeks before screening, is not on a stable dosing regimen for at least 14 days prior to the Screening visit, or who is unable to maintain stable dosing throughout the study.
  • Unable to withhold the use of oral comfort agents (eg, Oasis, MouthKote, etc) following enrollment in the study (Visit 1).
  • Shows evidence of a significant active or ongoing oral infection or other oral conditions (eg, lichen planus) that, in the opinion of the Investigator, might affect the safety of the subject or be exacerbated during study participation.
  • Acutely infected salivary glands or suspected closure of the salivary glands.
  • A condition that may confound the diagnosis of primary Sjögren's syndrome.
  • Received an investigational drug within the past 30 days.
  • Received 552-02 in a previous study.
  • History of multiple drug allergies or allergy to any medicine chemically related to the study drug (eg, amiloride, Moduretic, Midamor, triamterene).
  • Any clinically significant allergic disease, including food allergies, with the exception of nonactive hayfever.
  • Present history of any clinically significant and uncontrolled neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, or hematological disorder or disease, or any other major disorder or disease, in the opinion of the Investigator.
  • Sitting blood pressure at screening higher than 150/90 mmHg or lower than 100/50 mmHg after resting for 5 minutes.
  • Sitting pulse rate at screening outside the range of 50 - 90 beats per minute (bpm) after resting for 5 minutes.
  • Consumes more than 2 alcoholic drinks per day or has a significant history of alcoholism or drug/chemical abuse within the past 12 months.
  • History of using tobacco products within the last 3 months.
  • Has viral hepatitis or tests positively for the hepatitis B surface antigen (HBsAg) or hepatitis C (non-A, non-B) antibody, or a positive result for human immunodeficiency virus (HIV) antibodies.
  • Positive serum pregnancy test or is nursing (female subjects only).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo to match oromucosal formulation of 552-02
Experimental: 552-02
The oromucosal formulation of 552-02 contains 552-02 (25 μg/mL), surfactant, flavoring agents, a humectant, and preservatives.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Global assessment of dry mouth, as assessed by visual analog scale (VAS), in subjects with primary Sjögren's syndrome.
Time Frame: 49 Days
49 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety of daily administration of an oromucosal formulation of 552-02 in subjects with primary Sjögren's syndrome.
Time Frame: 49 Days
49 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

February 26, 2009

First Submitted That Met QC Criteria

February 26, 2009

First Posted (Estimate)

February 27, 2009

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

July 1, 2014

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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