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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 parameters

Changes 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

Page last updated: August 20, 2015

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