Clinical trial NCT00852839: A Safety and Efficacy Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's Syndrome
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Parallel Arm Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Mouth Associated With Sjogren's Syndrome
Xerostomia
Keywords: Dry mouth
Sjogren's syndrome
Xerostomia
Lead sponsor: Parion Sciences
Sponsor class: INDUSTRY
First posted: 2009-02-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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).

Primary outcomes:
measure: Global assessment of dry mouth, as assessed by visual analog scale (VAS), in subjects with primary Sjögren's syndrome.
timeFrame: 49 Days
Secondary outcomes:
measure: To evaluate the safety of daily administration of an oromucosal formulation of 552-02 in subjects with primary Sjögren's syndrome.
timeFrame: 49 Days
Other outcomes:
Locations:
city: Trumbull
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida College of Dentristy
state: Florida
city: Indianapolis
country: United States
facility: Indiana School of Dentristy
state: Indiana
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma University
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Rheumatology Associates
state: Pennsylvania
city: Knoxville
country: United States
facility: Rheumatology Consultants
state: Tennessee
city: Dallas
country: United States
facility: Arthritis Centers of Texas
state: Texas
city: San Antonio
country: United States
facility: Univ. of Texas Health Science Center
state: Texas
city: Spokane
country: United States
facility: Arthritis Northwest
state: Washington
Study officials:
References: