Prucalopride versus placebo in patients with significantly delayed gastric emptying of idiopathic and diabetic nature

Phase 1

• Conditions: Patients with delayed gastric emptying (t1/2 for solids = 109 min) either from idiopathic or diabetic origin; MedDRA version: 14.0Level: LLTClassification code 10021227Term: Idiopathic gastroparesisSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 14.0Level: PTClassification code 10051153Term: Diabetic gastroparesisSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-000308-16-BE
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-23
• Study Completion: 2013-12-10
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Consecutive patients who present to the motility outpatient clinic in whom a diagnosis of diabetic gastroparesis or functional dyspepsia with idiopathic gastroparesis is established according to Rome III criteria, and a diagnosis of delayed gastric emptying is made with a breath test (t1/2 for solids = 109 min)

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Presence of oesophagitis, gastric atrophy or erosive gastroduodenal lesions on endoscopy
2. Presence of obstructive lesions on small bowel X-ray
3. Major abdominal surgery
4. Underlying psychiatric illness
5. Use of non-steroidal anti-inflammatory drugs, steroids, or drugs affecting gastric motility

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: The evaluation of several questionnaires: the PAGI-SYM, PAGI-QoL, the daily symptoms in the patient diary, the Nepean Dyspepsia Index (SF-NDI)symptom scores and the NDI quality of life scores<br>;Primary end point(s): 1. A decrease in cumulative score for 6 meal-related symptoms (epigastric pain, bloating, postprandial fullness, nausea, belching, and epigastric burning) obtained at each breath sample, using a validated self-administered 4-level Lickert scale<br>2. A decrease on the PAGI- SYM questionnaire (GCSI) ;Timepoint(s) of evaluation of this end point: week 4 and week 10 of treatment;Main Objective: To investigate the effect of 4-week treatment with Prucalopride on gastric emptying time and meal-related symptoms in idiopathic and diabetic gastroparesis.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. A decrease in gastric half emptying time (t1/2) of liquids determined by 13C glycin breath test<br>2. A decrease in gastric half emptying time (t1/2) of solids determined by 14C octanoic acid breath test<br>;Timepoint(s) of evaluation of this end point: week 4 and week 10 of treatment