A Phase 3 interventional study of Colesevelam and Clonidine in Fecal Incontinence and Bile Acid Malabsorption, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Mayo Clinic · Phase 3, Interventional, and Treatment
Among 101 studies in Fecal Incontinence with a site in United States — 14 open to participants now, 19 under way, 2 of them phase 3. Fecal Incontinence · United States.
Among the 101 studies in Fecal Incontinence with a site in United States, this one is the 28th largest by enrollment of the 79 interventional ones that give a count, is one of 7 that started in 2015, is one of 4 in phase 3, and was the 49th registered.
283 studies on the registry are indexed under Fecal Incontinence; 52 are open to participants now.
Browse Fecal Incontinence studies →14 of the 101 studies in Fecal Incontinence with a site in United States are open now. Recruiting first, the newest first:
University of Colorado, Denver · Sites in United States
Ages 2–30
Cedars-Sinai Medical Center · Sites in United States
Ages 18+
Axonics, Inc. · Sites in United States, United Kingdom
Ages 18+
Axonics, Inc. · Sites in United States, Australia
Ages 18+
David Chu · Sites in United States
Ages 5+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 38 Fecal Incontinence studies recruiting now, 25 (66%) set no upper age limit and 9 (24%) stop at 75 or younger; 6 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 80 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
101 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 7 · Phase 3 5 · Phase 4 5
First in 1998; this study’s year is marked. 7 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 88 is above the median of 50 across 203 interventional studies indexed under Fecal Incontinence.
Median enrollment 44 across the 79 interventional studies, 80 across the 21 observational. Of the 70 that completed or were terminated, 35 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
27 of 101 have an industry lead sponsor. The 10 most frequent:
Mayo Clinic is the lead sponsor of 3,270 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Mayo Clinic has 4 studies filed under Fecal Incontinence — fewer than ten, so there is no comparison to draw.
11 of the studies in Fecal Incontinence with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05776277Phase 3Cook MyoSiteIltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury | 2026-12 |
| NCT07335484Axonics, Inc.Aquarius Pilot Study to Evaluate the New Axonics Trial System | 2026-11 |
| NCT04506593Indiana UniversityIndiana University Gastrointestinal Motility Diagnosis Registry | 2026-11 |
| NCT06186765Axonics, Inc.F15 Recharge Free Axonics SNM System Clinical Study | 2026-12 |
| NCT05200923MedtronicNeuroPelvic Health Electrically Evoked Recording (PEER) 2 Study | 2026-12-18 |
Add all 11 to your calendar (.ics) → With an account.
Among the 101 studies in Fecal Incontinence with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Compare the effects of a combination of colesevelam and clonidine to placebo on bowel symptoms in patients with urge or combined type of FI.
Fecal incontinence (FI) is a common symptom that can significantly impair quality of life. There is very limited, mostly uncontrolled, evidence to support the approaches currently used to manage FI. The alpha-2 adrenergic agonist clonidine decreased the frequency of loose stools in FI patients with diarrhea. Among patients with diarrhea, clonidine decreased the proportion of days with FI; however results were not statistically significant. Uncontrolled studies suggest that the bile acid binding resin colesevelam also increased stool consistency in patients with functional diarrhea. In this study, the investigators propose to compare the effects of a combination of colesevelam and clonidine to placebo on bowel symptoms in patients with urge or combined type of FI.
A. Phase 1
Inclusion Criteria:
i) Females aged 18-80 years with urge predominant or combined (i.e. urge plus passive) FI, as defined by a validated questionnaire, for at least 1 year duration will be eligible to participate.
Exclusion Criteria:
(i) History of clinically serious cardiovascular or pulmonary disease or showing 2nd degree atrioventricular block or higher.
(ii) Current or past history of rectal cancer, scleroderma, inflammatory bowel disease, small bowel obstruction, congenital anorectal abnormalities, Grade 2 rectal prolapse, history of rectal resection or pelvic irradiation (iii) Neurological disorders - Spinal cord injuries, dementia (Mini-Mental status score \<21), multiple sclerosis, Parkinson's disease, peripheral neuropathy (iv) Conditions precluding safe use of clonidine, i.e., symptomatic hypotension, or systolic blood pressure of \<100 mm Hg on initial visit in Phase 1 of study (v) Currently pregnant or nursing women (vi) Prior history of intolerance to clonidine or colesevelam (vii) Medications Absolute - opioid analgesics. Relative - other antihypertensive agents (i.e. if there is concern about synergistic effects and hypotension). Patients using drugs with anticholinergic effects will be excluded if they are used at high doses (e.g. nortriptyline greater than 50 mg/day or amitriptyline greater than 25 mg/day). Patients who use lower doses will be eligible to participate provided the dose will be stable during the study
B. Phase 2
Inclusion Criteria:
i) Females aged 18-80 years with urge predominant or combined (i.e. urge plus passive) FI for at least 1 year, as defined by questionnaire
Exclusion criteria:
(i) Positive urine pregnancy screen
C. Phase 3
Inclusion criteria:
(i) Completion of at least 5 out of 7 days of the diary in the preceding week and 10 out of 14 in the preceding 2 weeks (ii) At least 1 episode of FI per week averaged over 2 weeks (iii) Average Bristol stool score of 3 or higher (iv) Average stool frequency of ≥1/day
Exclusion criteria (if at least one is satisfied):
(i) Missing data in bowel diaries, i.e. if patient did not record bowel symptoms data for more than 2 days in 1 week or 4 days over 2 weeks (ii) Greater than 6 liquid [Bristol 6 or 7]) stools daily (iii) Average of less than 1 bowel movement daily (iv) Average Bristol stool score \<3 as assessed from analysis of bowel diaries
D. Phase 4
Inclusion criteria:
(i) All patients who complete at least 1 week of treatment with study drugs or placebo
Exclusion criteria:
(i) Patients who completed less than 1 week of treatment with study drugs or placebo
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive placebo for 4 weeks.
Other: Placebo
Participants in this arm will receive a combination of colesevelam (1.875 gm twice daily) and clonidine (0.1 mg oral twice daily) for 4 weeks.
Drug: Colesevelam · Drug: Clonidine
Participants who satisfy symptom criteria in Phase 2 will be randomized in a 1:1 ratio to receive either a combination of colesevelam (1.875 gm twice daily) and clonidine (0.1 mg oral twice daily) or an identical placebo for 4 weeks.
Also known as: Welchol
Participants who satisfy symptom criteria in Phase 2 will be randomized in a 1:1 ratio to receive either a combination of colesevelam (1.875 gm twice daily) and clonidine (0.1 mg oral twice daily) or an identical placebo for 4 weeks.
Also known as: Catapres
Placebo will be identical in appearance to the active drug.
Number of Participants to Report a 50% or Greater Reduction in Weekly Fecal Incontinence (FI) Episodes
The number of participants that report a 50% or greater reduction in weekly incontinent episodes as measured by self-reported bowel diaries.
Time frame: 4 weeks
Daily Stool Frequency
The number of bowel movements daily measured by self-reported bowel diaries.
Time frame: 4 weeks
Stool Consistency
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.
Time frame: 4 weeks
Number of Semi-Formed Stools Per Week
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)
Time frame: 4 weeks
Delay of Bowel Movement
The time in minutes a bowel movement can be delayed after sense of urgency to defecate as measured by self-reported bowel diaries.
Time frame: 4 weeks
Total Fecal Incontinence Episodes
The total number of fecal incontinence episodes per week as measured by self-reported bowel diaries.
Time frame: 4 weeks
Volume of Fecal Incontinence
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.
Time frame: 4 weeks
Percent of Incontinent Bowel Movements Pre-treatment
The percentage of bowel movements that were incontinent prior to treatment initiation, per self-reported bowel diaries.
Time frame: baseline
Percent of Incontinent Bowel Movements During Treatment
The percentage of bowel movements that were incontinent during treatment, per self-reported bowel diaries.
Time frame: 4 weeks
Percent of Incontinent Bowel Movements to be Semi-Formed Stools Pre-Treatment
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.
Time frame: baseline
Percent of Incontinent Bowel Movements to be Semi-Formed Stools During Treatment
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) during treatment, per self-reported bowel diaries.
Time frame: 4 weeks
Severity of Bowel Symptoms
The Fecal Incontinence Symptom Severity (FISS) score is based on five questions; (1) the frequency of FI; (2) the type of FI (stool only, liquid or mucus only, both liquid/mucus and stool, or gas only); (3) the amount of stool leaked (small, moderate, or large); (4) the frequency of having to rush to the toilet; and (5) the frequency of having stool leak without warning. Questions 4 \& 5 are merged to determine if the participant has passive FI (FI without warning), urge FI, both, or neither. The responses to the questions are assigned physician-derived weights and added together for a total score of 4 to 13. The higher the score the more severe the FI symptoms.
Time frame: 4 weeks
Severity of Fecal Incontinence
Measured by the Fecal Incontinence Severity Index (FISI). It is a validated 4-item scale used to assess the frequency (never, 1-3 times a month, once a week, 2 or more times per week but not daily, once a day, 2 or more times per day) of 4 different types of FI (gas, mucus, liquid stool, solid stool). Each of the four types of FI is awarded a number of points, depending on the frequency at which that type of incontinence is experienced. The points are totaled and the scores can range from 0 to 61, where the higher the score, the higher the perceived severity of the fecal incontinence.
Time frame: 4 weeks
Fecal Incontinence Quality of Life (FI-QoL)
The Fecal Incontinence Quality of Life questionnaire measures specific quality of life issues expected to affect patients with fecal incontinence. The questions are grouped into four categories: lifestyle (10 questions), coping (9 questions), depression (7 questions), and embarrassment (3 questions). Each category is scored from 1 to 4. The scale scores are calculated by adding the numerical values of all responses in that specific scale and then dividing by its number of items. Higher scores indicate a better quality of life.
Time frame: 4 weeks
Loperamide Tablets Per Week
The number of tablets of loperamide used, per self-reported bowel diaries.
Time frame: 4 weeks
| Milestone | Placebo | Colesevelam and Clonidine |
|---|---|---|
| Started | 32 | 24 |
| Completed | 30 | 22 |
| Not completed | 2 | 2 |
| Withdrew: Withdrawal by subject | 2 | 2 |
The number of participants that report a 50% or greater reduction in weekly incontinent episodes as measured by self-reported bowel diaries.
| Participants | Placebo | Colesevelam and Clonidine |
|---|---|---|
| Number of Participants to Report a 50% or Greater Reduction in Weekly Fecal Incontinence (FI) Episodes | 17 | 13 |
The number of bowel movements daily measured by self-reported bowel diaries.
| bowel movements per day | Placebo | Colesevelam and Clonidine |
|---|---|---|
| Daily Stool Frequency | 2.4 ± 2.3 | 2.1 ± 2.0 |
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.
| score on a scale | Placebo | Colesevelam and Clonidine |
|---|---|---|
| Stool Consistency | 4.1 ± 1.9 | 3.2 ± 1.5 |
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)
| number of stools per week | Placebo | Colesevelam and Clonidine |
|---|---|---|
| Number of Semi-Formed Stools Per Week | 1.0 ± 0.7 | 1.2 ± 1.1 |
The time in minutes a bowel movement can be delayed after sense of urgency to defecate as measured by self-reported bowel diaries.
| minutes | Placebo | Colesevelam and Clonidine |
|---|---|---|
| Delay of Bowel Movement | 2.8 ± 7.8 | 3.6 ± 8.4 |
The total number of fecal incontinence episodes per week as measured by self-reported bowel diaries.
| incontinence episodes per week | Placebo | Colesevelam and Clonidine |
|---|---|---|
| Total Fecal Incontinence Episodes | 4.2 ± 4.4 | 4.8 ± 3.7 |
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.
| incontinent episodes per week | Placebo | Colesevelam and Clonidine |
|---|---|---|
| Small (staining only) | 2.4 ± 1.8 | 3.3 ± 3.0 |
| Moderate (requires change of underwear) | 0.9 ± 1.7 | 2.0 ± 2.6 |
| Large (requires complete change of clothes | 1.3 ± 2.2 | 2.4 ± 6.2 |
The percentage of bowel movements that were incontinent prior to treatment initiation, per self-reported bowel diaries.
| percent of incontinent bowel movements | Placebo | Colesevelam and Clonidine |
|---|---|---|
| Percent of Incontinent Bowel Movements Pre-treatment | 45 ± 9 | 40 ± 10 |
The percentage of bowel movements that were incontinent during treatment, per self-reported bowel diaries.
| percent of incontinent bowel movements | Placebo | Colesevelam and Clonidine |
|---|---|---|
| Percent of Incontinent Bowel Movements During Treatment | 27 ± 8 | 28 ± 9 |
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.
| percent of semi-formed stools | Placebo | Colesevelam and Clonidine |
|---|---|---|
| Percent of Incontinent Bowel Movements to be Semi-Formed Stools Pre-Treatment | 61 ± 8 | 76 ± 8 |
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) during treatment, per self-reported bowel diaries.
| percent of semi-formed stools | Placebo | Colesevelam and Clonidine |
|---|---|---|
| Percent of Incontinent Bowel Movements to be Semi-Formed Stools During Treatment | 67 ± 8 | 61 ± 10 |
The Fecal Incontinence Symptom Severity (FISS) score is based on five questions; (1) the frequency of FI; (2) the type of FI (stool only, liquid or mucus only, both liquid/mucus and stool, or gas only); (3) the amount of stool leaked (small, moderate, or large); (4) the frequency of having to rush to the toilet; and (5) the frequency of having stool leak without warning. Questions 4 \& 5 are merged to determine if the participant has passive FI (FI without warning), urge FI, both, or neither. The responses to the questions are assigned physician-derived weights and added together for a total score of 4 to 13. The higher the score the more severe the FI symptoms.
| score on a scale | Placebo | Colesevelam and Clonidine |
|---|---|---|
| Severity of Bowel Symptoms | 6 ± 3.2 | 4.6 ± 3.6 |
Measured by the Fecal Incontinence Severity Index (FISI). It is a validated 4-item scale used to assess the frequency (never, 1-3 times a month, once a week, 2 or more times per week but not daily, once a day, 2 or more times per day) of 4 different types of FI (gas, mucus, liquid stool, solid stool). Each of the four types of FI is awarded a number of points, depending on the frequency at which that type of incontinence is experienced. The points are totaled and the scores can range from 0 to 61, where the higher the score, the higher the perceived severity of the fecal incontinence.
| score on a scale | Placebo | Colesevelam and Clonidine |
|---|---|---|
| Severity of Fecal Incontinence | 28 ± 15 | 22 ± 18 |
The Fecal Incontinence Quality of Life questionnaire measures specific quality of life issues expected to affect patients with fecal incontinence. The questions are grouped into four categories: lifestyle (10 questions), coping (9 questions), depression (7 questions), and embarrassment (3 questions). Each category is scored from 1 to 4. The scale scores are calculated by adding the numerical values of all responses in that specific scale and then dividing by its number of items. Higher scores indicate a better quality of life.
| score on a scale | Placebo | Colesevelam and Clonidine |
|---|---|---|
| Lifestyle score | 2.7 ± 0.9 | 2.7 ± 0.9 |
| Coping score | 2.0 ± 0.6 | 2.1 ± 0.8 |
| Depression Score | 3.1 ± 0.6 | 3.1 ± 0.8 |
| Embarrassment score | 2.6 ± 0.9 | 2.5 ± 0.9 |
The number of tablets of loperamide used, per self-reported bowel diaries.
| tablets per week | Placebo | Colesevelam and Clonidine |
|---|---|---|
| Loperamide Tablets Per Week | 1.9 ± 2 | 6 ± 5 |
Collected over Adverse events were collected from baseline to the end of study participation, for a total of approximately 12 weeks on each participant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/32 (0%) | 0/32 (0%) | 4/32 (12.5%) |
| Colesevelam and Clonidine | 0/24 (0%) | 0/24 (0%) | 6/24 (25%) |
| Event | Placebo | Colesevelam and Clonidine |
|---|---|---|
| Nausea and bloatingGeneral disorders | 0/32 | 2/24 |
| Intercurrent IllnessGeneral disorders | 1/32 | 2/24 |
| Difficulty swallowing pillsGeneral disorders | 2/32 | 2/24 |
| InsomniaGeneral disorders | 1/32 | 0/24 |
| Age, Continuous(years) | Placebo | Colesevelam and Clonidine | Total |
|---|---|---|---|
| Mean | 47 ± 26 | 53 ± 29 | 50 ± 27 |
| Sex: Female, Male(Participants) | Placebo | Colesevelam and Clonidine | Total |
|---|---|---|---|
| Female | 32 | 24 | 56 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | Colesevelam and Clonidine | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 32 | 24 | 56 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | Colesevelam and Clonidine | Total |
|---|---|---|---|
| United States | 32 | 24 | 56 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
The record gives a start of Nov 2015, a primary completion of Apr 2022 and a completion of Apr 2022. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2023, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Colesevelam · Clonidine