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NCT01369589 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Sjogren's Syndrome and Xerostomia, sponsored by Parion Sciences.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target
1
Study location

NCT01369589 is a Phase 1 study of Sjogren's Syndrome and Xerostomia that has completed, run by Parion Sciences. The registered enrollment target is 24 participants, below the 287-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01369589, a Phase 1 study of Sjogren's Syndrome and Xerostomia, has completed, sponsored by Parion Sciences.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target
1
Study location

Study Summary

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.

Interventions

  • DRUG Placebo
  • DRUG P-552

Study Locations (1)

Massachusetts

  • Tufts University School of Dental Medicine - Boston

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2010-11
Est. Completion 2011-04
Phase Phase 1

Sponsor

Parion Sciences

9 total trials

What the Registry Record Tells You About NCT01369589

The ClinicalTrials.gov registry entry for NCT01369589 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 287-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (92% lower). The listed sponsor is Parion Sciences, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Sjogren's Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01369589 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01369589 about?

NCT01369589 is a clinical study titled "An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness". 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 wetnes...

What is the current status of trial NCT01369589?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2010-11. Estimated completion is 2011-04.

What conditions does trial NCT01369589 study?

This clinical trial studies the following conditions: Sjogren's Syndrome, Xerostomia.

What interventions are being tested in trial NCT01369589?

The interventions under investigation include: Placebo (DRUG), P-552 (DRUG).

Who is sponsoring clinical trial NCT01369589?

This trial is sponsored by Parion Sciences, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01369589 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.