Constipation
Conditions
Brief summary
The purpose of this study is to determine the safety profile of 4 mg prucalopride in the treatment of chronic constipation.
Detailed description
To evaluate the potential differences in the adverse event (safety) profile between 4 mg of prucalopride daily for 4 weeks; titration up to a 4-mg total daily dose of prucalopride by starting at 1 mg for 2 days, 2 mg for 2 days, to 4 mg thereafter; and placebo given as oral tablets once daily for 4 weeks in patients with chronic constipation
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
* Male and non-pregnant, non-breast feeding female subjects at least 18 years of age (no upper age limit); * History of constipation. The subject reported having on average, 2 or fewer spontaneous bowel movements per week that resulted in a feeling or sensation 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 for at least a quarter of the stools; sensation of incomplete evacuation following at least a quarter of the stools; or straining at defecation at least a quarter of the time. The above criteria only applied to spontaneous bowel movements, (i.e., not preceded within a period of 24 hours by the intake of a laxative or use of an enema). A subject who never had spontaneous bowel movements was considered to be constipated and therefore eligible for the trial; * Constipation that was functional (i.e., not secondary to other causes); * Willingness and ability to fill out own diary and questionnaires; * Written informed consent, signed by the subject or legally acceptable representative and by the investigator; and * Availability for follow-up during the trial period, as determined in the protocol.
Exclusion criteria
* Subjects in whom constipation was thought to be drug-induced or who were using any disallowed medication; * Subjects suffering from secondary causes of chronic constipation. For example: Endocrine disorders: insulin-dependent diabetes mellitus; hypopituitarism; hypothyroidism; hypercalcemia; pseudo-hypoparathyroidism; pheochromocytoma; or glucagon-producing tumors. Endocrine disorders controlled by appropriate medical therapy were not excluded, with the exception of insulin-dependent diabetes mellitus Metabolic disorders: porphyria; uremia; hypokalemia; or amyloid neuropathy. Metabolic disorders controlled by appropriate medical therapy were not excluded •
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with an average of ≥3 SCBM/week | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with an average increase of ≥1 SCBM/week | 4 weeks |
Outcome results
None listed