eostigmine for patients with weak or absent esophageal peristalsis

Phase 1

• Conditions: Patients with complaints of dysphagia and poor esophageal motility; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2019-002187-26-BE
• Lead Sponsor: KU Leuven - TARGID

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-02
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.A minimum of 18 years old;
2.Ineffective Esophageal Motility (IEM), fragmented peristalsis or absent contractility, as determined on HRM in the last three months before inclusion in the study, using the Chicago classification v3.0 (1). IEM is defined as =50% of 5ml liquid swallows being weak or failed (DCI < 450 mmHg·s·cm) with a normal integrated relaxation pressure (IRP4). Fragmented peristalsis is defined as =50% of 5ml liquid swallows being fragmented (large break (>5 cm length) in the 20-mmHg isobaric contour with DCI >450 mmHg·s·cm) and not ineffective, with a normal IRP4. Absent contractility is defined a 100% failed swallows (DCI < 100 mmHg·s·cm), with a normal IRP4.
3.Have completed a gastro-duodenoscopy, within 12 months, showing no anatomical abnormality of the stomach or esophagus which can explain the patients symptoms.
4.History of dysphagia for at least 2 months, at least twice per week in the last month.
5.Sexually active women of child bearing potential participating in the study must be on an appropriate form contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. If the female patient has not been on oral, injectable, implantable or intrauterine contraception, a urinary pregnancy test will be performed prior to administration of neostigmine.
6.Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1.Endoscopic signs of severe erosive esophagitis (grade C or D, Los Angeles classification) on endoscopy performed during PPI treatment in the 12 months prior to screening, or = grade B when endoscopy is performed off PPI treatment.
2.Systemic diseases, known to affect esophageal motility (i.e. systemic sclerosis).
3.Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed).
4.QT c>450 ms.
5.Myasthenia Gravis or Eaton Lambert Syndrome.
6.Use of medication which effect cholinergic function such as anticholinergics, tricyclic antidepressants, calcium channel blockers.
7.Concomitant promotility agents such as: prucalopride or domperidone.
8.Aminoglycoside antibiotics.
9.Corticosteroids.
10.A cardiac disorder effecting electrical conductivity of the heart OR uninvestigated chest pain OR uninvestigated shortness of breath OR uninvestigated syncope.
11.An ECG finding or a new conductive abnormality which has not been previously identified (i.e. heart block, LBBB).
12.Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.
13.Major psychiatric disorder.
14.Pregnancy or breast-feeding.
15.History of poor compliance.
16.History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
17.History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified