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A Trial in Healthy Volunteers, to Evaluate the Tolerability and Cardiac Safety of Prucalopride

NCT00488215 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2008-05-29

No results posted yet for this study

Summary

An escalating dose of prucalopride up to a maximum of 20 mg was given once daily to 32 healthy volunteers to determine safety at the maximum tolerable dose or at 20 mg.

Conditions

Interventions

DRUG

prucalopride

The dose will be consecutively escalated in 2 mg steps per day, starting from 2 mg up to 20 mg once daily or until severe drug-related adverse events occur (= individual maximum tolerable dose, on decision of the subject and/or investigator).

OTHER

Placebo

During the placebo session, the number of placebo tablets will be consecutively escalated in an identical way as described for prucalopride. This means 1 tablet more every day, up to 10 tablets.

Sponsors & Collaborators

  • Movetis

    lead INDUSTRY

Principal Investigators

  • M J Boyce, M.D. · Central Middlesex Hospital, London

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-01-31
Primary Completion
2000-03-31
Completion
2000-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00488215 on ClinicalTrials.gov