Prucalopride Versus Placebo in Gastroparesis

NCT ID: NCT02510976

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2021-01-08

Brief Summary

Controlled cross-over study of prucalopride 2 mg daily or placebo in gastroparesis (idiopathic or diabetic). Patients will be randomized to 4 week treatment with the first regimen (double-blind), followed by a 2-week washout and 4 week treatment with the second regimen in cross-over.

Detailed Description

To assess the influence of prucalopride (Resolor®) 2mg daily, 30 patients with idiopathic and 30 patients with diabetic gastroparesis will undergo two gastric emptying breath tests with concomitant assessment of meal-related symptoms, at the conclusion of two consecutive, 4-week treatment periods of prucalopride or placebo. The order of prucalopride and placebo treatment will be randomised at the initiation of the study. Medication for both patient groups, 30 patients with idiopathic and 30 patients with diabetic gastroparesis, will be randomized separately. Half of the subjects will receive placebo first; the other half will receive prucalopride first. Treatment periods will be separated by a wash-out period of 2 weeks. All drugs potentially affecting gastrointestinal motility or sensitivity will be discontinued at least two weeks prior to the initiation of the study. Informed consent will be obtained from each participant.

In order to establish the gastrointestinal symptom and quality-of-life profile of this cohort, each patient will complete the following validated self-reported instruments at baseline and at each of the two testing visits (table 1): Patients assessment of Gastrointestinal symptoms (PAGISYM), Patients assessment of Gastrointestinal Quality of Life Impact (PAGIQoL) Gastrointestinal and Global Severity Score, Patient Health Questionnaire (PHQ-15), Appetite Questionnaire, Hospital Anxiety and Depression Scale, Visceral Sensitivity Index, Short Form Nepean Dyspepsia Index (SF-NDI). The PAGI-SYM is a comprehensive questionnaire of upper GI symptoms, and it includes a gastroparesis questionnaire module: the Gastroparesis Cardinal Symptom Index (GCSI), which has been validated in (idiopathic) gastroparesis.26 Furthermore, during the entire study duration patients will complete a daily symptom diary, incorporating a separate horizontal 100-mm visual analogue scale (VAS) for each of 9 upper abdominal symptoms. As prucalopride has a well-known therapeutic effect in chronic constipation, patients will also register information about their stool frequency and stool type in the daily diary (Bristol Stool Scale).

Conditions

Gastroparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Prucalopride

Prucalopride tablet 2 mg

Group Type: ACTIVE_COMPARATOR

prucalopride

Intervention Type: DRUG

Placebo

matching placebo tablet

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

prucalopride

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Other Intervention Names

Resolor

Eligibility Criteria

Inclusion Criteria

• Consecutive patients with a previously established diagnosis of diabetes or functional dyspepsia according to Rome III criteria, and with delayed gastric emptying (t1/2 for solids ≥ 109 min) on a breath test

Exclusion Criteria

• The presence of oesophagitis, gastric atrophy or erosive gastroduodenal lesions on endoscopy

• the presence of lesions on small bowel X-ray
• major abdominal surgery
• underlying psychiatric illness
• use of non-steroidal anti-inflammatory drugs, steroids, or drugs affecting gastric motility.
• Major co-morbidities

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospitals

Leuven, Flanders, Belgium

Countries

Belgium

Other Identifiers

S53094

Identifier Type: -

Identifier Source: org_study_id