Clincosm LogoSign in Get a demo

Effects of Serotonin Agonist Buspirone on Multimodal Esophageal Stimulation in Healthy Volunteers

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT04352686
Collaborator
(none)
10
Enrollment
2
Arms
9
Actual Duration (Months)

Study Details

Study Description

Brief Summary

To investigate if buspirone, a partial 5-HT-1A receptor agonist, is able to modify esophageal sensitivity, assessed by the multimodal stimulation.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Other
Official Title:
Effects of Serotonin Agonist Buspirone on Multimodal Esophageal Stimulation in Healthy Volunteers
Actual Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Nov 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Buspirone

Buspirone 20 mg per oral

Drug: Buspirone
Administration of buspirone to assess esophageal sensitivity
Placebo Comparator: Placebo

Placebo

Drug: Placebo
Administration of placebo to assess differences in esophageal sensitivity

Outcome Measures

Primary Outcome Measures

  1. Change in sensitivity to thermal stimulation [After 30 minutes after administration buspirone]

    To detect changes in thermal stimulation for sensitivity

Secondary Outcome Measures

  1. Change in sensitivity to mechanical stimulation [After 45 minutes after administration buspirone]

    To detect changes in mechanical stimulation for sensitivity

  2. Change in sensitivity to electrical stimulation [After 60 minutes after administration buspirone]

    To detect changes in electrical stimulation for sensitivity

  3. Change in sensitivity to chemical stimulation [After 75 minutes after administration buspirone]

    To detect changes in chemical stimulation for sensitivity

  4. Change in positive and negative affect score [At the beginning of the study and at the end of the multimodal stimulation]

    to detect change in affect of the multimodal stimulation

  5. Change in state trait and anxiety score [At the beginning of the study and at the end of the multimodal stimulation]

    to detect changes in the score due to the multimodal stimulation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • HV aged between 18 - 60 years
Exclusion Criteria:

  • history of psychiatric disease or a positive first degree psychiatric family history

  • pregnancy or lactation

  • concomitant administration of any centrally activating medication (anti-depressive medication, hypnotics, sedatives, anxiolytics, …)

  • medication affecting esophageal motility

  • significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic)

  • prior history of esophageal, gastric surgery or endoscopic anti-reflux procedure

  • history of gastrointestinal disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof Dr Jan Tack, Prof Dr, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT04352686
Other Study ID Numbers:
  • Busprione MuMoS HV
First Posted:
Apr 20, 2020
Last Update Posted:
Apr 20, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Gastroesophageal Reflux
Buspirone

Study Results

No Results Posted as of Apr 20, 2020