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NCT01316770 · ClinicalTrials.gov registry record · Phase 2
Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome Subjects
A Phase 2 study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT01316770 is a Phase 2 study that was terminated before completion, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 14 participants.
The verdict
NCT01316770, a Phase 2 study, was terminated before completion, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
Background: Sjögren's syndrome is an autoimmune disease (where the immune system attacks normal body tissues) that affects the salivary glands. Many people with Sjögren's syndrome are not able to make enough saliva because their salivary glands are inflamed. The dry mouth that results can interfere with daily activities and can lead to dental cavities, mouth sores, and infections. Injections of corticosteroids into the parotid glands can improve saliva production in people with Sjögren's syndrome, but current treatment practices may provide only temporary relief. Researchers are interested in studying the effectiveness of stronger corticosteroid injections (using dexamethasone) to determine how the corticosteroid treatment actually works. Objectives: \- To evaluate the effectiveness and mechanics of dexamethasone injections to improve saliva production in individuals with primary Sjögren's syndrome. Eligibility: \- Women between 18 and greater of age who have been diagnosed with primary Sjögren's syndrome, and have had a biopsy of the minor salivary glands in the past 5 years that shows a moderate level of inflammation. Design: * Participants will be screened with a full medical history and physical examination, blood and urine tests, and salivary gland biopsies. Participants will also be screened with tests of saliva flow production and evaluation of the salivary ducts and glands, and will complete questionnaires about dry mouth symptoms. * At the first treatment visit, participants will receive an injection of dexamethasone into one parotid gland and an injection of saline into the other gland. After the injections, participants will provide a blood sample to test the level of dexamethasone in the blood. * Two weeks after the first treatment, participants will return for an evaluation visit to have saliva flow rate measurements taken, and will complete a questionnaire about dry mouth symptoms. * Four weeks after the first treatment, participants will have a
Interventions
- DRUG Dexamethasone Parotid Irrigation
- DRUG Placebo Parotid Irrigation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2011-05-01 |
| Est. Completion | 2017-04-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01316770
The ClinicalTrials.gov registry entry for NCT01316770 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dexamethasone Parotid Irrigation is the first listed.
NCT01316770 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01316770 about?
NCT01316770 is a clinical study titled "Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome Subjects". Background: Sjögren's syndrome is an autoimmune disease (where the immune system attacks normal body tissues) that affects the salivary glands. Many people with Sjögren's syndrome are not able to make enough saliva because their salivary glands are inflamed. The dry mouth that results can interfere...
What is the current status of trial NCT01316770?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2011-05-01. Estimated completion is 2017-04-17.
What interventions are being tested in trial NCT01316770?
The interventions under investigation include: Dexamethasone Parotid Irrigation (DRUG), Placebo Parotid Irrigation (DRUG).
Who is sponsoring clinical trial NCT01316770?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
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