Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Parion Sciences
ClinicalTrials.gov Identifier:
NCT01369589
First received: June 6, 2011
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

The primary objective of this clinical study is to determine the impact of P-552 oral rinse on salivary volume after administration of a single dose of P-552and versus vehicle rinse. Changes in oral mucosal wetness will be assessed via collection of salivary output and via measurement of oral wetness using the Periotron 8000 instrument.


Condition Intervention Phase
Xerostomia
Sjogren's Syndrome
Drug: P-552
Drug: Vehicle rinse
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness in Subjects With Xerostomia Related to Sjogren's Syndrome

Resource links provided by NLM:


Further study details as provided by Parion Sciences:

Primary Outcome Measures:
  • Salivary volume [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
  • Salivary Volume [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Periotron measurement [ Time Frame: 15, 30 and 90 minutes ] [ Designated as safety issue: No ]
    measurement of mucosal wetness


Enrollment: 24
Study Start Date: November 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: P-552 oral rinse
P-552 oral rinse (10 mL volume containing 5 mg of P-552)
Drug: P-552
P-552 oral rinse ( 10 mL containing 5 mg P-552)
Placebo Comparator: Placebo
Vehicle oral rinse (10 mL)
Drug: Vehicle rinse
Water for Injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females, aged 18 years or older, and who are capable of providing their written informed consent to participate in the study.
  2. Male subjects must be either not sexually active, surgically sterilized, or agree to use an appropriate "double-barrier" method (such as a diaphragm and condom) during study participation and for at least 30 days after the completion of dosing.
  3. Non-pregnant female subjects must be either not sexually active, postmenopausal, or surgically sterilized; or agree to use an appropriate "double-barrier" method (such as a diaphragm and condom); or are currently using a prescribed transdermal, injection, implant, or oral contraceptive for at least 30 days before receiving the first dose of study drug during study participation and at least 30 days after the completion of dosing.
  4. Are in good health, as determined by a medical history, a physical examination, a detailed oral examination, and results of clinical chemistry, hematology and urinalysis.
  5. Has minimal level of unstimulated whole mouth salivary flow (greater than or equal to 0.05 milliliters [i.e., 0.05 grams] per 5 minutes) at the screening visit.
  6. Have a diagnosis of primary Sjogren's syndrome consistent with the revised version of the European criteria proposed by the American-European Consensus Group European Cooperative Community Classification Criteria for Sjogren's Syndrome.

Exclusion Criteria:

  1. Regularly uses antihistamines that have been started or the dose adjusted within the last 30 days.
  2. Has 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 is unable to maintain stable dosing throughout the study.
  3. Is unable to withhold the use of systemic cholinergic secretagogues and oral comfort agents (e.g., OraMoist, MouthKote, Biotene products, etc.) on the morning of each study visit and until 2 hours after dosing at study visits; and is unable to take the last nighttime dose at a standard time throughout the study.
  4. Is unable to maintain a stable dosage regimen of any concomitant medication throughout the duration of the trial.
  5. Shows evidence of a significant active or ongoing oral infection or other oral conditions (e.g., lichen planus) that, in the opinion of the investigator, might affect the safety of the subject or might exacerbate during study participation.
  6. Has acutely infected salivary glands (with or without pain) or suspected closure of the salivary glands.
  7. Has received an investigational drug within the past 30 days.
  8. Has a history of allergy to any medicine chemically related to the study drug (e.g., amiloride, Moduretic, Midamor, triamterene).
  9. Has a present history of any clinically significant and uncontrolled neurologic, gastrointestinal, renal, hepatic, cardiovascular (including hyper/hypotension and tachy/bradycardia), psychological, pulmonary, metabolic, endocrine, or hematological disorder or disease, or any other major disorder or disease, in the opinion of the investigator.
  10. Has viral hepatitis or tested positively for the hepatitis B surface antigen or hepatitis C (nonA, non-B) antibody, or a positive result for human immunodeficiency virus antibodies.
  11. Has a positive serum pregnancy test or is nursing (female subjects only).
  12. Should not participate in the study, in the opinion of the Principal or Clinical investigator.
  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: NCT01369589

Locations
United States, Massachusetts
Tufts University School of Dental Medicine
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Parion Sciences
  More Information

No publications provided

Responsible Party: Parion Sciences
ClinicalTrials.gov Identifier: NCT01369589     History of Changes
Other Study ID Numbers: 552-209S
Study First Received: June 6, 2011
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Parion Sciences:
Xerostomia
dry mouth
Sjogren's Syndrome

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

ClinicalTrials.gov processed this record on November 20, 2014