delayed gastric emptying MedDRA version: 12.1 Level: LLT Classification code 10012199 Term: Delayed gastric emptying
Conditions
Interventions
Trade Name: Amisulpride EG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: AMISULPRIDE
CAS Number: 71675859
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
UZLeuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: delayed gastric emptying for solids proven with a gastric emptying test (t1/2 > 75 minutes) age between 18 and 70 years 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: organical gastro-enterological pathology current major psychiatric pathology prolonged QT on ECG intake of medication which may induce 'torsades de pointes' or 'hypokalemia' intake of prokinetics intake of more than one antidepressant (SSRI and TCA) or intake of an instable dose of an antidepressant during the last 3 months intake of neuroleptics pregnancy or lactation a medical history with major abdominal chirurgy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of amisulpride for the control of symptoms related to the Gastroparesis Cardinal Symptom Index;Secondary Objective: To evaluate the overall treatment evaluation, the gastric emptying time, the symptoms during a gastric emptying test, the daily symptoms in the patient diary, the Nepean Dyspepsia Index (SF-NDI)symptom scores and the NDI quality of life scores ;Primary end point(s): Evaluation of the improvement of the GCSI (gastroparesis cardinal symptom index), a validated gastroparesis severity scale, after treatment with amisulpride compared to placebo. | — |
Countries
Belgium
Outcome results
None listed