MRI Assessment of Mode of Action of Bisacodyl, Single Dose
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
Constipation remains an important unmet medical need. Patients are currently often
dissatisfied with treatment, because of lack of predictability of the laxative, side effects
(mainly abdominal pain) and perceived decrease of efficacy with time. A recent systematic
review of a range of laxatives reported that bisacodyl increases the number of complete
spontaneous bowel movements statistically significant compared to placebo. Recently
non-invasive Magnetic Resonance Imaging (MRI) techniques have been developed to assess small
intestinal fluid distribution, transit and motility as well as colonic fluid, volumes and
motility in healthy volunteers and constipated subjects. Other laxatives such as movecol and
ispaghula have been investigated using this methodology. This study will use these novel
techniques to further characterize bisacodyl's mode of action.
This study is intended to assess the effect of a single-dose of bisacodyl on the gut motor
function and its effect on water distribution within the small and large intestine in
subjects with occasional constipation by MRI. It may allow better understanding of the
relative importance of both the secretory and the prokinetic effect of bisacodyl.
Since bisacodyl is often used by self-medicating people with constipation it is proposed to
study subjects suffering from occasional constipation. As such subjects often take the drug
intermittently it would be of interest to study both the acute response after single dose and
the response after several days of treatment to see if this alters the response.
The current study will be performed as a cross-over with 2-period and 2-treatment
(bisacodyl/placebo), for assessing the effects over of a single-dose of 5mg bisacodyl.
Evaluations will be performed after one single dose of bisacodyl or placebo in two different
time periods, separated by a 2 week washout period between end of period 1 and start of
period 2.
The study will recruit individuals ≥18yrs from the general public who consider themselves as
suffering from occasional constipation and who self-medicate with an occasional over-the
counter (OTC) laxative, not more than once a week. Up to 18 adult healthy subjects will be
recruited to ensure 10 evaluable subjects. An evaluable subject is defined as participant
having the primary endpoint assessed (ascending colon T1 300, 375, and 450 minutes correctly
evaluated) for the two periods of the crossover.