Early Phase 1
N=30
Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc)
Systemic Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT02363478 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: 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 — 0.9; 4.5; 0.3; 0.4 mmHg — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- buspirone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laikο General Hospital, Athens
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0.9; 4.5; 0.3; 0.4 | <0.05 sig |
| PRIMARY Changes From Baseline in Manometric Parameters: Duration of Contractions at the Distal Part of the Esophagus at Week 4 |
0.5 | — |
| PRIMARY Changes From Baseline in Manometric Parameters: Velocity of Contractions at the Distal Part of the Esophagus at Week 4 |
0.3 | — |
| SECONDARY Changes in the Severity of Esophageal Symptoms at Week 4 |
14.9; 13.2; 6.9; 1.9 | 0.05 |
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).
Eligibility Criteria
Inclusion Criteria
- SSc patients with esophageal symptoms
Exclusion Criteria
- none
Data sourced from ClinicalTrials.gov (NCT02363478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.