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

Prucalopride versus Placebo in Idiopathic and Diabetic Gastroparesis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000308-16-BE

Enrollment

Registered

2011-06-23

Start date

2011-10-24

Completion date

Unknown

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with delayed gastric emptying (t1/2 for solids = 109 min) either from idiopathic or diabetic origin MedDRA version: 14.0 Level: LLT Classification code 10021227 Term: Idiopathic gastroparesis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.0 Level: PT Classification code 10051153 Term: Diabetic gastroparesis System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Resolor Pharmaceutical Form: Film-coated tablet INN or Proposed INN: PRUCALOPRIDE CAS Number: 179474-81-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 ;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 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.	—

Measure

Time frame

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 ;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 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

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

Countries

Belgium

Contacts

Public ContactJan Tack

UZLeuven

jan.tack@med.kuleuven.be3216344225

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026