- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01369589
An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness
April 16, 2019 updated by: Parion Sciences
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
- Phase 1
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
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Tufts University School of Dental Medicine
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males or females, aged 18 years or older, and who are capable of providing their written informed consent to participate in the study.
- 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.
- 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.
- 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.
- 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.
- 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:
- Regularly uses antihistamines that have been started or the dose adjusted within the last 30 days.
- 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.
- 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.
- Is unable to maintain a stable dosage regimen of any concomitant medication throughout the duration of the trial.
- 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.
- Has acutely infected salivary glands (with or without pain) or suspected closure of the salivary glands.
- Has received an investigational drug within the past 30 days.
- Has a history of allergy to any medicine chemically related to the study drug (e.g., amiloride, Moduretic, Midamor, triamterene).
- 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.
- 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.
- Has a positive serum pregnancy test or is nursing (female subjects only).
- Should not participate in the study, in the opinion of the Principal or Clinical investigator.
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: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: P-552 on Day 1 and Placebo on Day 2
Randomly assigned subjects will receive a single dose of P-552 on Day 1 followed by a single dose of Placebo on Day 2
|
P-552 will be administered as 10 mL mouth rinse to be swished in the mouth fro 30 seconds and then completely expectorated.
Other Names:
Placebo will be administered as 10 mL mouth rinse to be swished in the mouth for 30 seconds and then completely expectorated.
Other Names:
|
Experimental: Placebo on Day 1 and P-552 on Day 2
Randomly assigned subjects will receive a single dose of Placebo on Day 1 followed by a single dose of P-52 on Day 2
|
P-552 will be administered as 10 mL mouth rinse to be swished in the mouth fro 30 seconds and then completely expectorated.
Other Names:
Placebo will be administered as 10 mL mouth rinse to be swished in the mouth for 30 seconds and then completely expectorated.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Salivary volume
Time Frame: 60 minutes
|
60 minutes
|
Salivary Volume
Time Frame: 120 minutes
|
120 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Periotron measurement
Time Frame: 15, 30 and 90 minutes
|
measurement of mucosal wetness
|
15, 30 and 90 minutes
|
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
November 1, 2010
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
June 6, 2011
First Submitted That Met QC Criteria
June 7, 2011
First Posted (Estimate)
June 9, 2011
Study Record Updates
Last Update Posted (Actual)
April 23, 2019
Last Update Submitted That Met QC Criteria
April 16, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Eye Diseases
- Disease
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Stomatognathic Diseases
- Mouth Diseases
- Lacrimal Apparatus Diseases
- Arthritis, Rheumatoid
- Salivary Gland Diseases
- Dry Eye Syndromes
- Syndrome
- Sjogren's Syndrome
- Xerostomia
Other Study ID Numbers
- 552-209S
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.
Clinical Trials on Sjogren's Syndrome
-
The Cleveland ClinicBristol-Myers SquibbWithdrawnRheumatoid Arthritis | Inflammatory Arthritis | Primary Sjogren's Syndrome | Secondary Sjogren's SyndromeUnited States
-
RemeGen Co., Ltd.RecruitingPrimary Sjogren's SyndromeChina
-
Stanford UniversityWithdrawnPrimary Sjogren's Syndrome
-
Matthew C. BakerWithdrawnPrimary Sjogren's SyndromeUnited States
-
University College, LondonCambridge University Hospitals NHS Foundation Trust; Sheffield Teaching Hospitals... and other collaboratorsActive, not recruitingSjogren's Syndrome Childhood-onsetUnited Kingdom, Ireland
-
Keio UniversityUnknown
-
University Hospital MuensterNovartisCompletedPrimary Sjogren's SyndromeGermany
-
Parion SciencesCompletedXerostomia | Dry Mouth Associated With Sjogren's SyndromeUnited States
-
Akdeniz UniversityCompleted
Clinical Trials on P-552
-
AbbVieRecruitingAlzheimer's Disease (AD)United States, Japan, New Zealand, Australia, Spain, Germany, United Kingdom
-
Parion SciencesCompleted
-
AbbVieCompleted
-
AbbVieActive, not recruitingHealthy VolunteerUnited States
-
Parion SciencesCompletedXerostomia | Dry Mouth Associated With Sjogren's SyndromeUnited States
-
AmgenRecruitingSolid TumorsCanada, Korea, Republic of, Australia, Netherlands, United States, Israel, Austria, Spain, United Kingdom, France, Belgium, Italy, Japan, Czechia, Hungary, Poland, Brazil, Argentina, Portugal, Denmark, Greece, Mexico, Switzerland, Rom... and more
-
Five Prime Therapeutics, Inc.Zai Lab (Shanghai) Co., Ltd.CompletedGastric CancerUnited States, Spain, China, Italy, Korea, Republic of, Portugal, Taiwan, Japan, Turkey, France, Hungary, Thailand, Germany, Poland, Australia, Belgium, Romania, United Kingdom
-
AmgenRecruitingGastric Cancer | Gastroesophageal Junction AdenocarcinomaKorea, Republic of, United States, Israel, Italy, Spain, Australia, Germany, United Kingdom, Austria, France, Japan, Switzerland, Taiwan, Belgium, Poland, China, Thailand, Canada, Czechia, Singapore, Hungary, Argentina, Brazil, Portugal, Roman... and more
-
Coloplast A/SCompleted
-
University of OregonOregon Social Learning CenterCompletedChild BehaviorUnited States