MRI Assessment of Mode of Action of Bisacodyl, Multiple Doses (MODEM)
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|ClinicalTrials.gov Identifier: NCT04129788|
Recruitment Status : Not yet recruiting
First Posted : October 17, 2019
Last Update Posted : October 18, 2019
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 movecol2 and ispaghula3 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.
|Condition or disease||Intervention/treatment||Phase|
|Constipation||Drug: Bisacodyl 5 milligram Drug: Placebo oral tablet||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Phase IV, single center, double blind, randomized (1:1 ratio), two arms (bisacodyl and placebo), multiple doses, and crossover clinical trial.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||The study is a double blind study with a randomization ratio 1:1. The subjects, the investigator and the Sanofi team will be blinded to the treatment sequences allocation until the database lock. The medicinal product and placebo are indistinguishable using exactly the same packing and form.|
|Primary Purpose:||Basic Science|
|Official Title:||A Phase IV, Crossover, Randomized, Double Blind and Placebo-controlled Clinical Trial to Evaluate the Mode of Action of Multiple Doses of Bisacodyl in Subjects With Occasional Constipation|
|Estimated Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
bisacodyl 5mg tablet, once a day on three consecutive days
Drug: Bisacodyl 5 milligram
three doses taken, one per day on three consecutive days
Other Name: dulcolax
Placebo Comparator: placebo
tablet, once a day on three consecutive days
Drug: Placebo oral tablet
three doses taken, one per day on three consecutive days
- Consistency of chyme in ascending colon [ Time Frame: Area under the curve 300-450 minutes after third intake of intervention ]as measured by MRI (T1)
- Longer term consistency of chyme in ascending colon [ Time Frame: 24 hours after third drug intake ]as measured by MRI (T1)
- Gut motor function [ Time Frame: 0-150 and 150-450 minutes after third intake of intervention ]colonic and small bowel motility as assessed by MRI
- Small intestinal water content [ Time Frame: 0-150 and 150-450 minutes after third intake of intervention ]as measured by MRI
- Colon volumes [ Time Frame: 0-150 and 150-450 minutes after third intake of intervention ]as measured by MRI
- Speed of whole gut transit [ Time Frame: at 450 minutes and 24 hours after transit marker and third study drug intake ]weighted average position score of transit markers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129788
|Contact: Robin Spiller, PhDfirstname.lastname@example.org|
|Contact: Neele Dellschaft, PhD||+44 115 email@example.com|
|University of Nottingham|
|Nottingham, Nottinghamshire, United Kingdom, NG7 2RD|
|Principal Investigator:||Robin Spiller, PhD||University of Nottingham|