Trial · NCT02628626

A Study of Colesevelam in Fecal Incontinence

NCT02628626, Phase 3, Completed, Mayo Clinic; results first posted 2023-06-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Colesevelam in Fecal Incontinence. Trials, record NCT02628626. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02628626

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Colesevelam in Fecal Incontinence
NCT number: NCT02628626
Status: Completed
Phases: Phase 3
Enrollment: 88 participants, actual
Lead sponsor: Mayo Clinic
Conditions: Fecal Incontinence, Bile Acid Malabsorption
Interventions: Colesevelam, Clonidine, Placebo
First posted: 2015-12-11
Last updated: 2023-06-22
Results first posted: 2023-06-22

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants to Report a 50% or Greater Reduction in Weekly Fecal Incontinence (FI) Episodes	4 weeks	The number of participants that report a 50% or greater reduction in weekly incontinent episodes as measured by self-reported bowel diaries.
Secondary	Daily Stool Frequency	4 weeks	The number of bowel movements daily measured by self-reported bowel diaries.
Secondary	Stool Consistency	4 weeks	Stool consistency as measured by self-reported bowel diaries. Expressed in terms of the Bristol Stool Form Scale, where: 1= separate hard lumps; 2= lumpy sausage-shape; 3= cracked sausage; 4= smooth and soft sausage; 5=soft blobs; 6=mushy, fluffy pieces; 7= watery, no solid pieces.
Secondary	Number of Semi-Formed Stools Per Week	4 weeks	The number of stools per week measured by self-reported bowel diaries where the Bristol stool score was 5, 6, or 7. (5=soft blobs; 6=mushy, fluffy pieces; 7= watery, no solid pieces)
Secondary	Delay of Bowel Movement	4 weeks	The time in minutes a bowel movement can be delayed after sense of urgency to defecate as measured by self-reported bowel diaries.
Secondary	Total Fecal Incontinence Episodes	4 weeks	The total number of fecal incontinence episodes per week as measured by self-reported bowel diaries.
Secondary	Volume of Fecal Incontinence	4 weeks	The volume of fecal incontinence measured as the number of incontinent episodes per week as categorized by small (staining only), moderate (requiring change of underwear) or large (requiring change of all clothes) in self-reported bowel diaries.
Secondary	Percent of Incontinent Bowel Movements Pre-treatment	baseline	The percentage of bowel movements that were incontinent prior to treatment initiation, per self-reported bowel diaries.
Secondary	Percent of Incontinent Bowel Movements During Treatment	4 weeks	The percentage of bowel movements that were incontinent during treatment, per self-reported bowel diaries.
Secondary	Percent of Incontinent Bowel Movements to be Semi-Formed Stools Pre-Treatment	baseline	The percentage of incontinent bowel movements where the Bristol stool score was 5, 6 or 7. (5=soft blobs; 6=mushy, fluffy pieces; 7= watery, no solid pieces), pre-treatment, per self-reported bowel diaries.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Participants to Report a 50% or Greater Reduction in Weekly Fecal Incontinence (FI) Episodes	4 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Daily Stool Frequency	4 weeks	bowel movements per day	MEAN
SECONDARY	Stool Consistency	4 weeks	score on a scale	MEAN
SECONDARY	Number of Semi-Formed Stools Per Week	4 weeks	number of stools per week	MEAN
SECONDARY	Delay of Bowel Movement	4 weeks	minutes	MEAN
SECONDARY	Total Fecal Incontinence Episodes	4 weeks	incontinence episodes per week	MEAN
SECONDARY	Volume of Fecal Incontinence	4 weeks	incontinent episodes per week	MEAN
SECONDARY	Percent of Incontinent Bowel Movements Pre-treatment	baseline	percent of incontinent bowel movements	MEAN
SECONDARY	Percent of Incontinent Bowel Movements During Treatment	4 weeks	percent of incontinent bowel movements	MEAN
SECONDARY	Percent of Incontinent Bowel Movements to be Semi-Formed Stools Pre-Treatment	baseline	percent of semi-formed stools	MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Participants to Report a 50% or Greater Reduction in Weekly Fecal Incontinence (FI) Episodes	Placebo	17		Participants
Number of Participants to Report a 50% or Greater Reduction in Weekly Fecal Incontinence (FI) Episodes	Colesevelam and Clonidine	13		Participants
Daily Stool Frequency	Placebo	2.4	Standard Deviation 2.3	bowel movements per day
Daily Stool Frequency	Colesevelam and Clonidine	2.1	Standard Deviation 2.0	bowel movements per day
Stool Consistency	Placebo	4.1	Standard Deviation 1.9	score on a scale
Stool Consistency	Colesevelam and Clonidine	3.2	Standard Deviation 1.5	score on a scale
Number of Semi-Formed Stools Per Week	Placebo	1.0	Standard Deviation 0.7	number of stools per week
Number of Semi-Formed Stools Per Week	Colesevelam and Clonidine	1.2	Standard Deviation 1.1	number of stools per week
Delay of Bowel Movement	Placebo	2.8	Standard Deviation 7.8	minutes
Delay of Bowel Movement	Colesevelam and Clonidine	3.6	Standard Deviation 8.4	minutes

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	32
Overall Study	STARTED	Colesevelam and Clonidine	24
Overall Study	COMPLETED	Placebo	30
Overall Study	COMPLETED	Colesevelam and Clonidine	22
Overall Study	NOT COMPLETED	Placebo	2
Overall Study	NOT COMPLETED	Colesevelam and Clonidine	2

Source ClinicalTrials.gov

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea and bloating	General disorders	Placebo	0	32	0
other	Nausea and bloating	General disorders	Colesevelam and Clonidine	2	24	2
other	Intercurrent Illness	General disorders	Placebo	1	32	1
other	Intercurrent Illness	General disorders	Colesevelam and Clonidine	2	24	2
other	Difficulty swallowing pills	General disorders	Placebo	2	32	2
other	Difficulty swallowing pills	General disorders	Colesevelam and Clonidine	2	24	2
other	Insomnia	General disorders	Placebo	1	32	1
other	Insomnia	General disorders	Colesevelam and Clonidine	0	24	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	32
Total, all-cause mortality	Colesevelam and Clonidine	0	24
Total, other adverse events	Placebo	4	32
Total, other adverse events	Colesevelam and Clonidine	6	24
Total, serious adverse events	Placebo	0	32
Total, serious adverse events	Colesevelam and Clonidine	0	24

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
R01DK078924	Pathophysiology of Anorectal Disorders	BHARUCHA, ADIL E.	MAYO CLINIC ROCHESTER	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2008 to 2023	NIH RePORTER
UL1RR024150	Mayo Clinic Center for Translational Science Activities	RIZZA, ROBERT A.	MAYO CLINIC ROCHESTER	NATIONAL CENTER FOR RESEARCH RESOURCES	2006 to 2011	NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Colesevelam and Clonidine vs Placebo: deaths from any cause	Trial comparisons
Colesevelam and Clonidine vs Placebo: Number of Participants to Report a 50% or Greater Reduction in Weekly Fecal Incontinence (FI) Episodes	Trial comparisons
Colesevelam and Clonidine vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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