ConstipationPhase 4MODEMNCT04129788
MRI Assessment of Mode of Action of Bisacodyl, Multiple Doses
A Phase 4 study testing Bisacodyl 5 milligram in people with Constipation, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- Bisacodyl 5 milligram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Oct 2020to 1 Nov 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- I 01. Adult subjects that self-medicate with occasional laxative no more than 4 times in the month before eligibility confirmation
- I 02. Meet Rome IV criteria for Chronic Constipation.
- I 03. ≥18 years of age inclusive, at the time of signing the informed consent.
- I 04. Screening diary confirms they experience at least 2 days in the 7 day diary with either hard stools (Bristol Stool form Score 1 or 2) or no bowel movement
- I 05. BMI under or equal to 35 kg/m2
- I 06. Female subjects of child bearing potential must have a negative urine pregnancy test at screening. Subjects of child bearing potential or with partners of child bearing potential must agree to use methods of medically acceptable forms of contraception during the study and for 90 days after completion of study drug, (e.g. implants, injectable, combined oral contraceptives, barrier methods, true abstinence (when this is in line with the preferred and usual lifestyle of the patient) or vasectomised partners).
- I 07. Capable of giving signed informed consent as described in Appendix 1 (Section 10.1) which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- E 01. Known hypersensitivity or other contraindications to bisacodyl use: such as ileus, intestinal obstruction, acute abdominal conditions including appendicitis, acute inflammatory bowel diseases, and severe abdominal pain associated with nausea and vomiting; and severe dehydration or rare hereditary conditions that may be incompatible with an excipient of the product (galactose intolerance, e.g. galactosaemia, fructose intolerance.
- E 02. Pregnancy and/or breast breast-feeding or positive urine pregnancy test History of known gastrointestinal organic disease (i.e. celiac disease, inflammatory bowel diseases).
- E 03. A positive diagnosis of irritable bowel syndrome based on the Rome IV criteria questionnaire which requires the patient to experience abdominal pain at least weekly
- E 04. Reported history of previous major abdominal surgery (excluding appendectomy and cholecystectomy)
- E 05. Any medical condition making participation potentially compromising the participation in the study (e.g. diabetes mellitus, respiratory disease limiting ability to lie in the scanner, known allergy to one of the food products) as per investigator's judgment
- E 06. Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
Show all 12Show fewer
- E 07. Any condition incompatible with the patient's participation to the study as per investigator's judgment.
- E 08. Not willing or able agree to dietary restrictions required in 24 hours before each MRI study day
- E 09. Anticipate need for antibiotics intake during the study.
- E 10. Unwilling to stop probiotics for the duration of the study period
- E 11. Unable/ not willing to stop drugs known to alter GI motility including, regular loperamide, antispasmodics, (e.g. buscopan, mebeverine, peppermint oil, alverine citrate), eluxadoline opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists for the duration of the study (Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants (< 30mg amitriptyline or 50mg nortriptyline) will be recorded but provided dose is stable, will not be an exclusion criteria).
- E 12. Having taken part in a research study within 3 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Nottingham, Nottinghamshire, NG7 2RD
About this study
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
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.
Read more
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.
- Conditions
- Constipation
- Being tested
- Bisacodyl 5 milligram, Placebo oral tablet
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bisacodyl 5 milligramDrug
Also called dulcolax
three doses taken, one per day on three consecutive days
Placebo oral tabletDrug
three doses taken, one per day on three consecutive days
| Study group | Role | What they receive |
|---|---|---|
| bisacodyl | Experimental | bisacodyl 5mg tablet, once a day on three consecutive days Receives: Drug: Bisacodyl 5 milligram |
| placebo | Placebo comparator | tablet, once a day on three consecutive days Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistency of chyme in ascending colon
as measured by MRI (T1)
Measured: Area under the curve 300-450 minutes after third intake of intervention
Secondary outcomes (5)
Longer term consistency of chyme in ascending colon
as measured by MRI (T1)
Measured: 24 hours after third drug intake
Gut motor function
colonic and small bowel motility as assessed by MRI
Measured: 0-150 and 150-450 minutes after third intake of intervention
Small intestinal water content
as measured by MRI
Measured: 0-150 and 150-450 minutes after third intake of intervention
Colon volumes
as measured by MRI
Measured: 0-150 and 150-450 minutes after third intake of intervention
Speed of whole gut transit
weighted average position score of transit markers
Measured: at 450 minutes and 24 hours after transit marker and third study drug intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start4 Oct 2020
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Robin Spiller, University of Nottingham
- Investigators
- Robin Spiller, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129788
- Sponsor's protocol ID
- CHC-2019-12563
- Acronym
- MODEM
- Status last verified
- Jun 2024
- First submitted
- 14 Oct 2019
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Aliyu A, Dellschaft N, Hoad C, Williams H, Gaudoin E, Sulaiman S, Crooks C, Gowland P, Aran A, Lange R, Bois De Fer B, Corsetti M, Marciani L, Spiller R. Magnetic Resonance Imaging Reveals Novel Insights into the Dual Mode of Action of Bisacodyl: A Randomized, Placebo-controlled Trial in Constipation. Clin Pharmacol Ther. 2025 May;117(5):1284-1291. doi: 10.1002/cpt.3532. Epub 2024 Dec 16.
PubMed 39679695
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04129788
- Acronym / sponsor ID
- MODEM / CHC-2019-12563
- Conditions
- Constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 4 Oct 2020 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase IV, single center, double blind, randomized (1:1 ratio), two arms (bisacodyl and placebo), multiple doses, and crossover clinical trial.
| Arm | Type | Receives |
|---|---|---|
| bisacodyl | Experimental | Drug: Bisacodyl 5 milligrambisacodyl 5mg tablet, once a day on three consecutive days |
| placebo | Placebo comparator | Drug: Placebo oral tablettablet, once a day on three consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- I 01. Adult subjects that self-medicate with occasional laxative no more than 4 times in the month before eligibility confirmation
- I 02. Meet Rome IV criteria for Chronic Constipation.
- I 03. ≥18 years of age inclusive, at the time of signing the informed consent.
- I 04. Screening diary confirms they experience at least 2 days in the 7 day diary with either hard stools (Bristol Stool form Score 1 or 2) or no bowel movement
- I 05. BMI under or equal to 35 kg/m2
Key exclusion criteria (12 listed)
- E 01. Known hypersensitivity or other contraindications to bisacodyl use: such as ileus, intestinal obstruction, acute abdominal conditions including appendicitis, acute inflammatory bowel diseases, and severe abdominal pain associated with nausea and vomiting; and severe dehydration or rare hereditary conditions that may be incompatible with an excipient of the product (galactose intolerance, e.g. galactosaemia, fructose intolerance.
- E 02. Pregnancy and/or breast breast-feeding or positive urine pregnancy test History of known gastrointestinal organic disease (i.e. celiac disease, inflammatory bowel diseases).
- E 03. A positive diagnosis of irritable bowel syndrome based on the Rome IV criteria questionnaire which requires the patient to experience abdominal pain at least weekly
- E 04. Reported history of previous major abdominal surgery (excluding appendectomy and cholecystectomy)
- E 05. Any medical condition making participation potentially compromising the participation in the study (e.g. diabetes mellitus, respiratory disease limiting ability to lie in the scanner, known allergy to one of the food products) as per investigator's judgment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bisacodyl 5 milligramAlso: dulcolaxthree doses taken, one per day on three consecutive days | Drug | bisacodyl |
| Placebo oral tabletthree doses taken, one per day on three consecutive days | Drug | placebo |
Primary outcome
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)
5 secondary outcomes
Longer term consistency of chyme in ascending colon
Time frame: 24 hours after third drug intake
Gut motor function
Time frame: 0-150 and 150-450 minutes after third intake of intervention
Small intestinal water content
Time frame: 0-150 and 150-450 minutes after third intake of intervention
Colon volumes
Time frame: 0-150 and 150-450 minutes after third intake of intervention
Speed of whole gut transit
Time frame: at 450 minutes and 24 hours after transit marker and third study drug intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 39679695Aliyu A, Dellschaft N, Hoad C, Williams H, Gaudoin E, Sulaiman S, Crooks C, Gowland P, Aran A, Lange R, Bois De Fer B, Corsetti M, Marciani L, Spiller R. Magnetic Resonance Imaging Reveals Novel Insights into the Dual Mode of Action of Bisacodyl: A Randomized, Placebo-controlled Trial in Constipation. Clin Pharmacol Ther. 2025 May;117(5):1284-1291. doi: 10.1002/cpt.3532. Epub 2024 Dec 16.
- Individual participant dataSharing planned: Yes
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Spiller, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bisacodyl 5 milligram in people with Constipation, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consistency of chyme in ascending colon (time frame: Area under the curve 300-450 minutes after third intake of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04129788, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.