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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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19 October 2017 |
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Main ID: |
NCT02363478 |
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Date of registration:
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29/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc)
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Scientific title:
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Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc) |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02363478 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Early Phase 1
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Countries of recruitment
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Greece
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Contacts
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Name:
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Georgios Karamanolis |
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Address:
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Telephone:
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Email:
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Affiliation:
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Academic Department of Gastroenterology, Laikon GH |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- SSc patients with esophageal symptoms
Exclusion Criteria:
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Sclerosis
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Intervention(s)
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Drug: buspirone
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Primary Outcome(s)
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Changes From Baseline in Manometric Parameters: Velocity of Contractions at the Distal Part of the Esophagus at Week 4
[Time Frame: before and after 4 weeks buspirone administration]
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Changes From Baseline in Manometric Parameters: Duration of Contractions at the Distal Part of the Esophagus at Week 4
[Time Frame: before and after 4 weeks buspirone administration]
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Changes From Baseline in Manometric Parameters: i) Amplitude of Contractions at the Distal Part of the Esophagus and ii) Resting and Residual (Lower Esophageal Pressure) LES Pressure and IRP (Integrated Relaxation Pressure) at Week 4
[Time Frame: before and after 4 weeks buspirone administration]
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Secondary Outcome(s)
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Changes in the Severity of Esophageal Symptoms at Week 4
[Time Frame: before and after 4 weeks buspirone administration]
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Secondary ID(s)
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Laikon 181/21-02-2014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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