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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01369589
• Date of registration: 06/06/2011
• Prospective Registration: No
• Primary sponsor: Parion Sciences
• Public title: An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness
• Scientific 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
• Date of first enrolment: November 2010
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01369589
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Xerostomia

Sjogren's Syndrome

Intervention(s)

Drug: Placebo

Drug: P-552

Primary Outcome(s)

Salivary Volume [Time Frame: 120 minutes]

Salivary volume [Time Frame: 60 minutes]

Secondary Outcome(s)

Periotron measurement [Time Frame: 15, 30 and 90 minutes]

Secondary ID(s)

552-209S

Source(s) of Monetary Support

Please refer to primary and secondary sponsors