NCT02510976

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2021

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

9.2 years

First QC Date

July 27, 2015

Last Update Submit

July 9, 2024

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

  • GCSI questionnaire score

    validated gastroparesis questionnaire

    after 4 weeks

Secondary Outcomes (4)

  • PAGI SYM questionnaire scores

    after 4 weeks

  • NDI questionnaire scores

    after 4 weeks

  • Gastric half emptying time

    after 4 weeks

  • Daily diary symptom and stool pattern scores

    over 4 weeks, weekly average

Other Outcomes (1)

  • adverse events

    over 4 weeks

Study Arms (2)

Prucalopride

ACTIVE COMPARATOR

Prucalopride tablet 2 mg

Drug: prucalopride

Placebo

PLACEBO COMPARATOR

matching placebo tablet

Drug: placebo

Interventions

prucaloprideDRUG
Also known as: Resolor
Prucalopride
placeboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals

Leuven, Flanders, 3000, Belgium

Location

MeSH Terms

Conditions

Gastroparesis

Interventions

prucalopride

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2015

First Posted

July 29, 2015

Study Start

November 1, 2011

Primary Completion

January 8, 2021

Study Completion

January 8, 2021

Last Updated

July 10, 2024

Record last verified: 2024-07

Locations

BE(1)