A Trial in Healthy Volunteers, to Evaluate the Tolerability and Cardiac Safety of Prucalopride
|ClinicalTrials.gov Identifier: NCT00488215|
Recruitment Status : Completed
First Posted : June 20, 2007
Last Update Posted : May 29, 2008
|Condition or disease||Intervention/treatment||Phase|
|Constipation||Drug: prucalopride Other: Placebo||Phase 1|
This is a single-centre, double-blind, placebo-controlled, cross-over trial in 32 healthy volunteers with two sessions (I and II). Each session consists of a run-in day for baseline assessments, 13 treatment days and 5 additional days for assessments. Subjects will be randomized to start with either the prucalopride or placebo session.
Between the 2 sessions, there will be a washout period of 14 to 21 days, to avoid any carry-over effect.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Double-Blind, Placebo-Controlled, 2-Way Cross-Over Trial in Healthy Volunteers, to Evaluate the Pharmacokinetics, Tolerability and Cardiac Safety of Oral Prucalopride at Steady State, After up-Titration to a Maximum of 20 mg.|
|Study Start Date :||January 2000|
|Primary Completion Date :||March 2000|
|Study Completion Date :||March 2000|
Active Comparator: 1
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 Name: Resolor
Placebo Comparator: 2
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.
- The exploration whether the maximum tolerable dose (MTD, defined as the highest dose not causing severe drug-related adverse events in > 50 % of the subjects) is achieved between 0 and 20 mg prucalopride. [ Time Frame: 26 days ]
- The documentation of laboratory and cardiovascular safety (vital signs, ECG, Holter monitoring) at the MTD or at 20 mg. [ Time Frame: 26 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00488215
|Principal Investigator:||M J Boyce, M.D.||Central Middlesex Hospital, London|