Constipation
Conditions
Brief summary
The purpose of this study is to determine whether prucalopride is safe and effective in the re-treatment of chronic constipation. Hypothesis: Retreatment is as effective and safe as treatment with prucalopride in patients with chronic constipation.
Detailed description
This is a multicentre, Phase III trial with a parallel-group design, consisting of a 2 week drug-free run-in period, followed by a 4-week double-blind, placebo-controlled treatment period, a drug-free washout period of at least 2 weeks, and a second 4-week double-blind treatment period. During the initial run-in period, the subject's bowel habit will be documented in a daily diary and the existence of constipation will be confirmed. Eligible subjects will be randomly allocated to double-blind treatment with either 4 mg prucalopride or placebo, given orally once daily before breakfast, for 4 weeks. After 4 weeks of treatment, each subject will enter a drug-free washout period. The length of the washout period will be either 2 or 4 weeks, depending on how long it takes for the subject to meet the criteria for constipation. If the subject is unable to re-qualify after a 4-week washout, the subject must be discontinued from the trial. Subjects who qualify for the second double-blind treatment period will receive the same treatment as during the first treatment period, once-daily for an additional four weeks.
Interventions
DRUGPrucalopride
4 mg o.d.
OTHERPlacebo
o.d.
Sponsors
Movetis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and non-pregnant, non-breast-feeding female outpatients at least 18 years of age (no upper age limit). 2. History of constipation; the patient reported having, on average, 2 or fewer spontaneous bowel movements per week that resulted in a feeling of complete evacuation as well as the occurrence of one or more of the following for at least 6 months before the selection visit: * very hard (little balls) and/or hard stools at least a quarter of the stools; * sensation of incomplete evacuation following at least a quarter of the stools; * straining at defecation at least a quarter of the time. The above criteria were only applicable for spontaneous bowel movements, i.e. not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema. Patients who never had spontaneous bowel movements were considered to be constipated and were eligible for the study. 3. Having functional constipation. Constipation that was not induced by secondary causes of constipation (see
Exclusion criteria
1 through 7). 4. Willing and able to fill out his/her own diary and questionnaires without help, and able to read and write English. 5. Written informed consent, signed by the patient or legally acceptable representative and by the investigator. 6. Availability for follow-up during the study period as determined in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion (%) of subjects with three or more spontaneous, complete bowel movements per week. | 8 weeks |
Outcome results
None listed