NCT02363478

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Dec 2014

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 16, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 24, 2016

Completed
Last Updated

October 24, 2016

Status Verified

August 1, 2016

Enrollment Period

9 months

First QC Date

January 29, 2015

Results QC Date

January 11, 2016

Last Update Submit

August 31, 2016

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (3)

  • 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

    before and after 4 weeks buspirone administration

  • Changes From Baseline in Manometric Parameters: Duration of Contractions at the Distal Part of the Esophagus at Week 4

    before and after 4 weeks buspirone administration

  • Changes From Baseline in Manometric Parameters: Velocity of Contractions at the Distal Part of the Esophagus at Week 4

    before and after 4 weeks buspirone administration

Secondary Outcomes (1)

  • Changes in the Severity of Esophageal Symptoms at Week 4

    before and after 4 weeks buspirone administration

Study Arms (1)

buspirone

EXPERIMENTAL

4-weeks buspirone administration (20mg) in patients with SSc and esophageal involvement

Drug: buspirone

Interventions

buspironeDRUG

buspirone 10 mg X2 for 4 weeks

Also known as: bespar
buspirone

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • SSc patients with esophageal symptoms

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Department of Gastroenterology, Laikon GH

Athens, 11527, Greece

Location

Related Publications (1)

  • Karamanolis GP, Panopoulos S, Denaxas K, Karlaftis A, Zorbala A, Kamberoglou D, Ladas SD, Sfikakis PP. The 5-HT1A receptor agonist buspirone improves esophageal motor function and symptoms in systemic sclerosis: a 4-week, open-label trial. Arthritis Res Ther. 2016 Sep 1;18(1):195. doi: 10.1186/s13075-016-1094-y.

    PMID: 27586891DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Spiro CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesPolycyclic Compounds

Results Point of Contact

Title
Dr. George P. Karamanolis
Organization
Academic Department of Gastroenterology, "LAIKON" General Hospital
georgekaramanolis@yahoo.co.uk
+30.213.2061307

Study Officials

  • Georgios Karamanolis

    Academic Department of Gastroenterology, Laikon GH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Gastroenterology

Study Record Dates

First Submitted

January 29, 2015

First Posted

February 16, 2015

Study Start

December 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 24, 2016

Results First Posted

October 24, 2016

Record last verified: 2016-08

Locations

GR(1)