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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Parion Sciences
ClinicalTrials.gov Identifier:
NCT00852839
First received: February 26, 2009
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Dry Mouth Associated With Sjogren's Syndrome
Xerostomia
Drug: Placebo
Drug: 552-02
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Vehicle-Controlled, Parallel Arm Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's Syndrome

Resource links provided by NLM:


Further study details as provided by Parion Sciences:

Primary Outcome Measures:
  • Global assessment of dry mouth, as assessed by visual analog scale (VAS), in subjects with primary Sjögren's syndrome. [ Time Frame: 49 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 140
Study Start Date: February 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 552-02 Drug: 552-02
The oromucosal formulation of 552-02 contains 552-02 (25 μg/mL), surfactant, flavoring agents, a humectant, and preservatives. The placebo formulation will be identical except for 552-02 content.
Placebo Comparator: Placebo Drug: Placebo
The placebo formulation will be identical to the oromucosal formulation of 552-02 except for 552-02 content.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852839

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

No publications provided

Responsible Party: Parion Sciences
ClinicalTrials.gov Identifier: NCT00852839     History of Changes
Other Study ID Numbers: 552-207S
Study First Received: February 26, 2009
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Parion Sciences:
Dry mouth
Sjogren's syndrome
Xerostomia

Additional relevant MeSH terms:
Xerostomia
Sjogren's Syndrome
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014