NCT00903747

Brief Summary

This is a 2-arm, parallel-group active- and placebo-controlled, double-blind randomised study, stratified by gender and with a hybrid crossover group design, to compare treatment with prucalopride 2 mg/day (intended therapeutic dose) and prucalopride 10 mg/day (supratherapeutic dose) with placebo. A single oral dose of 400 mg moxifloxacin is included as a positive control in terms of the effect on cardiac repolarisation. Study hypothesis: Treatment with therapeutic (2 mg) or supratherapeutic (10 mg) doses of prucalopride in healthy male and female volunteers will not increase QTc interval compared to placebo.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2009

Completed
Last Updated

May 18, 2009

Status Verified

May 1, 2009

Enrollment Period

3 months

First QC Date

May 15, 2009

Last Update Submit

May 15, 2009

Conditions

Constipation

Keywords

Prucalopridesafety study

Outcome Measures

Primary Outcomes (1)

  • Treatment with therapeutic (2 mg) or supratherapeutic (10 mg) doses of prucalopride in healthy male and female volunteers does not increase QTc interval compared to placebo.

    January to April 2009

Study Arms (2)

1

EXPERIMENTAL

Prucalopride

Drug: prucalopride

2

PLACEBO COMPARATOR

Placebo/moxifloxacin

Drug: moxifloxacinDrug: placebo

Interventions

prucaloprideDRUG

2-10 mg prucalopride

Also known as: Resolor
1
moxifloxacinDRUG

400 mg moxifloxacin (Group 2a)

Also known as: Avelox
2
placeboDRUG

placebo (Group 2b)

2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers aged between 18 to 50 years.
  • Body mass index (BMI) between 18 and 30 kg/m2.
  • Female subjects must:
  • be of childbearing potential with a negative serum β-human chorionic gonadotropin (β-HCG) test at screening, and be willing and able to use medically acceptable double barrier methods of birth control, throughout the whole study; or
  • be postmenopausal; or
  • have received surgical sterilisation at least 6 months before screening; AND
  • females must not be receiving hormone replacement therapy (HRT).

You may not qualify if:

  • Abnormal QTcF and/or heart rate/blood pressure values at baseline.
  • Subjects with ECG abnormalities that may interfere with the accurate assessment of the QT interval.
  • Subjects with known cardiovascular disorders.
  • Subjects with known clinically significant arrhythmias.
  • Subjects with risk factors e.g., Torsades de Pointes.
  • Subjects with clinically relevant, abnormal serum electrolytes or complete blood count (CBC) at screening.
  • Female subjects who are lactating or pregnant.
  • Subjects suffering from other significant medical conditions.
  • Subjects with a known allergy or sensitivity to moxifloxacin, or to prucalopride.
  • Subjects with a positive screening test for hepatitis B, hepatitis C, or HIV at screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mendzelevski B, Ausma J, Chanter DO, Robinson P, Kerstens R, Vandeplassche L, Camm J. Assessment of the cardiac safety of prucalopride in healthy volunteers: a randomized, double-blind, placebo- and positive-controlled thorough QT study. Br J Clin Pharmacol. 2012 Feb;73(2):203-9. doi: 10.1111/j.1365-2125.2011.04088.x.

    PMID: 21848574DERIVED

MeSH Terms

Conditions

Constipation

Interventions

prucaloprideMoxifloxacin

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Remi VD Broeck, MD

    Movetis NV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 15, 2009

First Posted

May 18, 2009

Study Start

January 1, 2009

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

May 18, 2009

Record last verified: 2009-05