Trial Outcomes & Findings for Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc) (NCT NCT02363478)

NCT ID: NCT02363478

Last Updated: 2016-10-24

Results Overview

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 22 participants
• Primary outcome timeframe: before and after 4 weeks buspirone administration
• Results posted on: 2016-10-24

Participant Flow

Participant milestones

Measure	Buspirone Participants received buspirone 20 mg/day for 4 weeks
Overall Study STARTED	30
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Buspirone Participants received buspirone 20 mg/day for 4 weeks
Overall Study Lost to Follow-up	4
Overall Study Adverse Event	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Buspirone n=22 Participants 22 out of 30 participants (19 female) completed the study.
Age, Continuous	52.5 years STANDARD_DEVIATION 11.6 • n=93 Participants
Sex: Female, Male Female	19 Participants n=93 Participants
Sex: Female, Male Male	3 Participants n=93 Participants
Region of Enrollment Greece	22 participants n=93 Participants

PRIMARY outcome

Timeframe: before and after 4 weeks buspirone administration

Outcome measures

Measure	Buspirone n=22 Participants Participants received buspirone 20 mg/day for 4 weeks
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 amplitude	0.9 mmHg Standard Deviation 0.2
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 LES resting pressure	4.5 mmHg Standard Deviation 0.7
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 LES residual pressure	0.3 mmHg Standard Deviation 0.2
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 IRP	0.4 mmHg Standard Deviation 0.2

PRIMARY outcome

Timeframe: before and after 4 weeks buspirone administration

Outcome measures

Measure	Buspirone n=22 Participants Participants received buspirone 20 mg/day for 4 weeks
Changes From Baseline in Manometric Parameters: Duration of Contractions at the Distal Part of the Esophagus at Week 4	0.5 sec Standard Deviation 0.4

PRIMARY outcome

Timeframe: before and after 4 weeks buspirone administration

Outcome measures

Measure	Buspirone n=22 Participants Participants received buspirone 20 mg/day for 4 weeks
Changes From Baseline in Manometric Parameters: Velocity of Contractions at the Distal Part of the Esophagus at Week 4	0.3 cm/sec Standard Deviation 0.5

SECONDARY outcome

Timeframe: before and after 4 weeks buspirone administration

Severity of esophageal symptoms (dysphagia, heartburn, regurgitation and chest pain) was measured on a 100-point visual analogue scale (VAS) ranging from 0 (absent) to 100 (very severe). Even minor decrease in the VAS score for each symptom at week 4 considered as improvement.

Outcome measures

Measure	Buspirone n=22 Participants Participants received buspirone 20 mg/day for 4 weeks
Changes in the Severity of Esophageal Symptoms at Week 4 heartburn	14.9 units on a scale Standard Deviation 7.8
Changes in the Severity of Esophageal Symptoms at Week 4 regurgitation	13.2 units on a scale Standard Deviation 2.7
Changes in the Severity of Esophageal Symptoms at Week 4 dysphagia	6.9 units on a scale Standard Deviation 8.8
Changes in the Severity of Esophageal Symptoms at Week 4 chest pain	1.9 units on a scale Standard Deviation 3.1

Adverse Events

Buspirone

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Buspirone n=30 participants at risk Participants received bouspirone 20 mg/day for 4 weeks
Ear and labyrinth disorders dizziness	6.7% 2/30
Gastrointestinal disorders nausea	6.7% 2/30

Additional Information

Dr. George P. Karamanolis

Academic Department of Gastroenterology, "LAIKON" General Hospital

Phone: +30.213.2061307

Email: georgekaramanolis@yahoo.co.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place