Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc)

Systemic Sclerosis Clinical Trial

Official title:

Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02363478
• Other study ID #: Laikon 181/21-02-2014
• Status: Recruiting
• Phase: Phase 0
• First received: January 29, 2015
• Last updated: February 13, 2015
• Start date: December 2014
• Est. completion date: March 2015

Study information

• Verified date: February 2015
• Source: Laikon General District Hospital, Athens
• Contact: Georgios Karamanolis
• Phone: 00302107286308
• Email: georgekaramanolis[@]yahoo.co.uk
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• SSc patients with esophageal symptoms

Exclusion Criteria:

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Drug:
• buspirone
buspirone 10 mg X2 for 4 weeks

Locations

Country	Name	City	State
Greece	Academic Department of Gastroenterology, Laikon GH	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Laikon General District Hospital, Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in manometric parameters		before and after 4 weeks buspirone administration	Yes
Primary	Changes in the severity of esophageal symptoms		before and after 4 weeks buspirone administration	Yes