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Prucalopride Versus Placebo in Gastroparesis

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Unknown status
CT.gov ID
NCT02510976
Collaborator
(none)
30
Enrollment
1
Location
2
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Prucalopride Versus Placebo in Functional Dyspepsia With Delayed Gastric Emptying
Study Start Date :
Nov 1, 2011
Actual Primary Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Prucalopride

Prucalopride tablet 2 mg

Drug: prucalopride
Other Names:
  • Resolor

    		•
    Placebo Comparator: Placebo

    matching placebo tablet

    Drug: placebo

    Outcome Measures

    Primary Outcome Measures

    1. GCSI questionnaire score [after 4 weeks]

      validated gastroparesis questionnaire

    Secondary Outcome Measures

    1. PAGI SYM questionnaire scores [after 4 weeks]

      validated upper GI questionnaire

    2. NDI questionnaire scores [after 4 weeks]

      validated upper GI QOL questionnaire

    3. Gastric half emptying time [after 4 weeks]

      gastric emptying test

    4. Daily diary symptom and stool pattern scores [over 4 weeks, weekly average]

      daily symptom diaries

    Other Outcome Measures

    1. adverse events [over 4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospitals Leuven Vlaanderen Belgium 3000

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT02510976
    Other Study ID Numbers:
    • S53094
    First Posted:
    Jul 29, 2015
    Last Update Posted:
    Dec 15, 2015
    Last Verified:
    Jul 1, 2015
    Additional relevant MeSH terms:
    Gastroparesis
    Prucalopride

    Study Results

    No Results Posted as of Dec 15, 2015