Primary: To evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment in male subjects with chronic constipation.Secondary: To evaluate the safety, tolerability, effect on quality of life and effect on symptoms of prucalopride…
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion (%) of subjects with an average of >= 3 SCBMs/week (i.e. a responder)
over the 12-week double-blind treatment period.
Secondary outcome
- Proportion (%) of subjects with an average increase of >= 1 SCBMs/week
compared to the run-in period, over the entire treatment period.
- The average number of (SC)BM/week and change from baseline
- Number of (SC)BMs per week: descriptive statistics and distribution in
categories as 0, (0;1), [1;2), [2;3), [3:*)
- Consistency per (SC)BM: descriptive statistics of 7-point score and % (SC)BM
with normal consistency (Type 3 or 4 on the Bristol stool scale).
- For more secondary endpoints, please refer to the study protocol.
Background summary
Prucalopride (Resolor®) is a new drug to stimulate intestinal motility. It
recently received a marketing authorization for the symptomatic treatment of
chronic constipation in women in whom laxatives fail to provide adequate
relief. Prucalopride belongs to a new chemical class of
dihydrobenzofuran-carboxamide derivatives with strong enterokinetic activity.
Study objective
Primary: To evaluate the efficacy of prucalopride versus placebo over 12 weeks
of treatment in male subjects with chronic constipation.
Secondary: To evaluate the safety, tolerability, effect on quality of life and
effect on symptoms of prucalopride versus placebo over 12 weeks of treatment in
male subjects with chronic constipation.
Study design
This is a multi-centre, randomised, parallel-group, double-blind,
placebo-controlled phase II trial in male subjects with chronic constipation.
Subjects will be screened and enter a 2- or 3-week run-in period during which
the presence of constipation will be confirmed. After the run-in period
subjects will be randomly assigned to placebo or prucalopride in an equal ratio
(1:1) if the subject fulfils the constipation criteria for inclusion. The
subjects will take 2 or 1 mg (depending on the age and response of the subject)
prucalopride or placebo once daily before breakfast during the entire 12-week
treatment period.
Intervention
Subjects will take the study medication (placebo or prucalopride) daily during
the study.
Study burden and risks
Data from phase II and phase III trials show that prucalopride is safe and well
tolerated in all patient groups studied to date, including the elderly and
children. The majority of side effects were mild to moderate in intensity and
transient. Laboratory and cardiovascular safety data showed no clinically
relevant changes during the course of treatment. The most frequently reported
adverse events (AEs) were headache, abdominal pain, nausea and diarrhea. Most
of these AEs occurred during the first week of treatment and were transient.
The subjects will visit the trial center at screening, baseline and after 2, 4,
8 and 12 weeks of treatment. During these visits, the following procedures will
take place: physical examination, blood and urine sampling, ECG,
questionnaires. Subjects are also asked to keep an electronic diary. If the
patients have no stool in 3 consecutive days, they are allowed to take rescue
medication.
Veedijk 58
Turnhout 2300
BE
Veedijk 58
Turnhout 2300
BE
Listed location countries
Age
Inclusion criteria
- subject is male out-patient >= 18 years of age.
- subject has a history of constipation, i.e. reports an average of <= 2 spontaneous bowel movements (SBM)/week, that result in a feeling of complete evacuation (SCBM) and one or more of the following for at least 6 months before the selection visit: - very hard (little balls) and/or hard stools for at least a quarter of the stools; - sensation of incomplete evacuation following for at least a quarter of the stoold; - straining at defecation for at least a quarter of the time. These criteria are only applicable for SBMs, i.e. BNs not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema. Subjects who never have SBMs are considered to be constipated and are eligible for the trial.
- Subject agrees to stop his current laxative treatment and is willing to use rescue medication according to the rescue rule (bisacodyl (Dulcolax) / enemas).
Exclusion criteria
- Subjects in whom constipation is thought to be drug-induced.
- Subjects using any disallowed medication.
- Subjects suffering from secondary causes of chronic constipation.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-015719-42-NL |
| ClinicalTrials.gov | NCT01147926 |
| CCMO | NL32873.068.10 |