Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc)
Information source: Laikon General District Hospital, Athens
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Systemic Sclerosis
Intervention: buspirone (Drug)
Phase: Phase 0
Status: Recruiting
Sponsored by: Laikon General District Hospital, Athens Official(s) and/or principal investigator(s): Georgios Karamanolis, Principal Investigator, Affiliation: Academic Department of Gastroenterology, Laikon GH
Overall contact: Georgios Karamanolis, Phone: 00302107286308, Email: georgekaramanolis@yahoo.co.uk
Summary
Esophagus is commonly affected in Systemic Sclerosis (SSc) and esophageal function is
compromised in about 75% of patients. Previous studies have shown that buspirone, an orally
available 5-HT1A (serotonin 1a) receptor agonist, enhances esophageal motility in healthy
volunteers. Recently, the investigators observed that a single dose of buspirone (10mg)
improves lower esophageal sphincter (LES) function in patients with SSc and esophageal
involvement .
Objectives: To evaluate the effect of continuous administration of buspirone on esophageal
dysfunction and related symptoms in SSc using high resolution manometry (HRM).
Clinical Details
Official title: Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc)
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Changes in manometric parametersChanges in the severity of esophageal symptoms
Detailed description:
Systemic sclerosis (SSc) is a chronic autoimmune disease affecting the skin and other organs
especially the gastrointestinal tract. Esophageal involvement occurs in up to 90% of SSc
patients. Symptoms of esophageal disease are due to gastroesophageal reflux disease (GERD)
and esophageal motor dysfunction. Thus, heartburn, regurgitation and dysphagia have been
reported by 80% of SSc patients.
The gold standard method for the assessment and detection of esophageal dysmotility in SSc
patients is manometry. High-resolution manometry (HRM) is the most accurate tool to assess
esophageal motility using multiple closely spaced (<2cm) pressure sensors, assessment of
esophageal motility is more sensitive ,and allows a better assessment of LES and of the
whole esophagus.
Buspirone, an orally available 5-HT1A receptor agonist, exerts a beneficial acute effect on
esophageal motor dysfunction and LES pressure and may enhances an important role in
improvement of esophageal symptoms in SSc patients. Thus, the investigators will conduct a
study to evaluate the putative beneficial long-term effect of buspirone i) on esophageal
motor dysfunction and ii) on esophageal symptoms in symptomatic SSc patients.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- SSc patients with esophageal symptoms
Exclusion Criteria:
- none
Locations and Contacts
Georgios Karamanolis, Phone: 00302107286308, Email: georgekaramanolis@yahoo.co.uk
Academic Department of Gastroenterology, Laikon GH, Athens 11527, Greece; Recruiting Georgios Karamanolis, Phone: 00302107286308, Email: georgekaramanolis@yahoo.co.uk
Additional Information
Starting date: December 2014
Last updated: February 13, 2015
|