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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: Completed Phase 1 study of Sjogren's Syndrome and Xerostomia, sponsored by Parion Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG P-552
Study Locations (1)
Massachusetts
- Tufts University School of Dental Medicine - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
What the finished NCT01369589 record still lists
NCT01369589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 287-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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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Where NCT01369589's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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