BridgeMD
Buspirone for weak or absent esophageal peristalsis
EU CTIS ID: 2024-516667-91-00
What this study is testing
To investigate the effect of buspirone on high-resolution manometry parameters (specifically: distal contractile integral, DCI) in patients with poor esophageal motility during a high resolution impedance manometry with 3 types of boluses (on liquid bolus, 5mL, in supine position)
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Ineffective motility or absent contractility identified on HRiM
- Primary complaint of dysphagia for a minimum of 2 months
- Age > 18 years
- No anatomical cause for symptoms
- No hiatal hernia ≥3 cm
- 5. Sexually active women of childbearing potential participating in the study must be using an appropriate form of contraception.
You likely can't join if
- Endoscopic signs of severe erosive esophagitis (grade C or D, Los Angeles classification) on endoscopy performed off PPI treatment in the 12 months prior to screening, or ≥ grade B when endoscopy is performed during PPI treatment.
- Major psychiatric disorder.
- Pregnancy or breastfeeding.
- History of poor compliance.
- History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
- History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
See the full eligibility criteria
- Ineffective motility or absent contractility identified on HRiM
- Primary complaint of dysphagia for a minimum of 2 months
- Age > 18 years
- No anatomical cause for symptoms
- No hiatal hernia ≥3 cm
- 5. Sexually active women of childbearing potential participating in the study must be using an appropriate form of contraception.
- Endoscopic signs of severe erosive esophagitis (grade C or D, Los Angeles classification) on endoscopy performed off PPI treatment in the 12 months prior to screening, or ≥ grade B when endoscopy is performed during PPI treatment.
- Major psychiatric disorder.
- Pregnancy or breastfeeding.
- History of poor compliance.
- History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
- History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
- Systemic diseases, known to affect esophageal motility (i.e. systemic sclerosis)
- Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed).
- Hiatal hernia ≥3 cm
- QT c>450 ms.
- Use of medication that effect cholinergic function such as anticholinergics, tricyclic antidepressants.
- Concomitant promotility agents such as prucalopride or domperidone.
- Concomitant use of more than one benzodiazepine.
- Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.