NCT04129788: MODEM

MRI Assessment of Mode of Action of Bisacodyl, Multiple Doses

Completed Phase 4 Last updated 3 July 2024

What this trial tests

Phase 4 trial testing Bisacodyl 5 milligram in Constipation in 12 participants. Completed in 1 November 2022.

Timeline

4 October 2020

Primary endpoint
1 November 2022

1 November 2022

Quick facts

Lead sponsor	University of Nottingham
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	basic science
Enrollment	12
Start date	4 October 2020
Primary completion	1 November 2022
Estimated completion	1 November 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• Bisacodyl 5 milligram — full drug profile →
• Placebo oral tablet — full drug profile →

Conditions studied

• Constipation — all drugs for Constipation →

Sponsor

University of Nottingham

Who can join

18 and older, any sex, with Constipation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 review1 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 multiple doses 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 multiple doses of 5mg bisacodyl.

Evaluations will be performed after multiple doses 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Magnetic Resonance Imaging Reveals Novel Insights into the Dual Mode of Action of Bisacodyl: A Randomized, Placebo-controlled Trial in Constipation.
   Aliyu A, Dellschaft N, Hoad C, Williams H, et al · · 2025 · cited 2× · PMID 39679695 · DOI 10.1002/cpt.3532