Botox injection into the upper esophageal sphincter in inability to belch: a study comparing botox with placebo.

Phase 1

Conditions: retrograde cricopharyngeus dysfunction
MedDRA version: 20.0Level: LLTClassification code: 10004222Term: Belching Class: 10017947
MedDRA version: 20.0Level: LLTClassification code: 10013128Term: Diseases of oesophagus Class: 10017947
Therapeutic area: Diseases [C] - Otorhinolaryngologic Diseases [C09]
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: CTIS2024-512546-42-00

Lead Sponsor: Algemeen Ziekenhuis Delta

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures, Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner., Between 18 and 65 years old, Inability to belch, which is bothersome enough to consider treatment, with or without any of the concomitant symptoms (bloathing, flatulence, gurgling noises, etc), Typical findings on high resolution impedance manometry with belch provocation test

Exclusion Criteria

Participant has a history of surgery in the upper GI tract, that might interfere with the belch reflex (such as anti-reflux surgery), Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol, Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial, to be decided at the discretion of the investigator., If applicable: Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive, Participation in another interventional Trial with an investigational medicinal product (IMP) or device, >65 years old; < 18 years of age