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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02112019 |
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Date of registration:
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08/04/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome
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Scientific title:
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Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome; A Randomised Controlled Pilot Study |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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50 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02112019 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Netherlands
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- A diagnosed (by the European League Against Rheumatism guidelines) primary or
secondary Syndrome of Sjögren
- Age: > 18 years and < 70 years
- A remaining salivary flow
Exclusion Criteria:
- A complete lack of measurable salivary flow, also after stimulation of the glands by
taste or chewing
- Acute sialadenitis
- Use of sialogogue medication (i.e. pilocarpine or cevimeline)
- Other severe illnesses or physical conditions that make a treatment under general
anesthesia impossible or highly riskful.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sjögren's Syndrome
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Intervention(s)
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Procedure: Sialoendoscopy
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Drug: hydrocortisone
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Drug: saline
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Primary Outcome(s)
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Change, compared to baseline and to a non-treatment control group, in unstimulated whole mouth saliva in ml/min after sialoendoscopic treatment
[Time Frame: Baseline, 2 years]
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Secondary Outcome(s)
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Change in mouthfeel score (XI score)
[Time Frame: Baseline, 2 years]
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Change, compared to baseline and to a non-treatment control group, in the stimulated parotid salivary flow after performing sialoendoscopic rinsing (with or without hydrocortisone)
[Time Frame: Baseline, 2 years]
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Change in the CODS score
[Time Frame: Baseline, 2 years]
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Change in the EULAR SS Patient Reported Index score
[Time Frame: Baseline, 2 years]
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Secondary ID(s)
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NL44018.029.13
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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