Prucalopride Versus Placebo in Gastroparesis

Gastroparesis Clinical Trial

Official title:

Prucalopride Versus Placebo in Functional Dyspepsia With Delayed Gastric Emptying

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02510976
• Other study ID #: S53094
• Status: Recruiting
• Phase: Phase 4
• First received: July 27, 2015
• Last updated: December 14, 2015
• Start date: November 2011

Study information

• Verified date: July 2015
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Jan Tack, M.D., Ph.D.
• Phone: +3216344228
• Email: jan.tack[@]med.kuleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Drug:
• prucalopride

• placebo

Locations

Country	Name	City	State
Belgium	University Hospitals	Leuven	Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse events		over 4 weeks	Yes
Primary	GCSI questionnaire score	validated gastroparesis questionnaire	after 4 weeks	No
Secondary	PAGI SYM questionnaire scores	validated upper GI questionnaire	after 4 weeks	No
Secondary	NDI questionnaire scores	validated upper GI QOL questionnaire	after 4 weeks	No
Secondary	Gastric half emptying time	gastric emptying test	after 4 weeks	No
Secondary	Daily diary symptom and stool pattern scores	daily symptom diaries	over 4 weeks, weekly average	No