Trial · NCT00884832

A Placebo-Controlled Study of Clonidine for Fecal Incontinence.

NCT00884832, Phase 2, Completed, Mayo Clinic; results first posted 2014-03-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Placebo-Controlled Study of Clonidine for Fecal Incontinence. Trials, record NCT00884832. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00884832

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Trial

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

Title: A Placebo-Controlled Study of Clonidine for Fecal Incontinence.
NCT number: NCT00884832
Status: Completed
Phases: Phase 2
Enrollment: 44 participants, actual
Lead sponsor: Mayo Clinic
Conditions: Fecal Incontinence
Interventions: Clonidine, Placebo
First posted: 2009-04-21
Last updated: 2014-03-06
Results first posted: 2014-03-06

Source ClinicalTrials.gov

Registered outcomes13

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

List	Outcome	Time frame	Description
Primary	Mean Fecal Incontinence and Constipation Assessment (FICA) Score	4 weeks baseline, 4 weeks treatment	The FICA severity scale has 4 items (frequency, type, amount of leakage, and presence of urgency) and is used to rate the severity of fecal incontinence. The parameter was computed from values in the weekly diaries. The FICA score can range from 1 to 13. Symptom severity scores of 1-6, 7-10, and 11-13 are categorized as mild, moderate, and severe, respectively. Scores were averaged over the 4 week baseline period and the 4 week treatment periods.
Secondary	Mean Number of Days With Fecal Incontinence	4 weeks baseline, 4 weeks treatment	Values were averaged over 4 week baseline and 4 week treatment periods.
Secondary	Mean Number of Fecal Incontinence Episodes	4 weeks baseline, 4 weeks treatment	Values were averaged over 4 week baseline and 4 week treatment periods.
Secondary	Mean Percentage of Bowel Movements Which Were Incontinent	4 weeks baseline, 4 weeks treatment	Values were averaged over 4 week baseline and 4 week treatment periods.
Secondary	Mean Severity of Fecal Incontinence	4 weeks baseline, 4 weeks treatment	The Fecal Incontinence Severity Index was used to compute the severity of fecal incontinence (FI). It is a validated 4-item scale used to assess the frequency of 4 different types of FI (gas, mucus, liquid stool, solid stool). The subject responses are weighted and summed for the 4 types of FI. Scores could range from 0 (no symptoms) to 61 (very frequent FI). Values were computed from pre- and post- treatment questionnaires.
Secondary	Impact of Fecal Incontinence on Baseline Quality of Life	4 weeks baseline	Scores were computed from a pre-treatment questionnaire, the Fecal Incontinence Quality of Life Scale. This scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items) Coping/Behavior (9 items), Depression/Self Perception (7 items), and Embarrassment (3 items). Scales range from 1 to 4; with a 1 indicating a lower functional status of quality of life. Scales scores are the average (mean) response to all items in the scale (that is, add the responses to all questions in a scale together and then divide by the number of items in the scale, adjusting for missing values).
Secondary	Impact of Fecal Incontinence on Post-Treatment Quality of Life	after 4 weeks treatment	Scores were computed from a post-treatment questionnaire, the Fecal Incontinence Quality of Life Scale. This scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items) Coping/Behavior (9 items), Depression/Self Perception (7 items), and Embarrassment (3 items). Scales range from 1 to 4; with a 1 indicating a lower functional status of quality of life. Scales scores are the average (mean) response to all items in the scale (that is, add the responses to all questions in a scale together and then divide by the number of items in the scale, adjusting for missing values).
Secondary	Satisfaction With Treatment	4 weeks baseline, 4 week treatment	This parameter was determined by a 100 mm visual analog scale, with possible scores ranging from 0 = "Not satisfied at all (no relief of symptoms)" to 100 = "Completely satisfied (symptoms resolved)." The parameter was computed from weekly diaries. Scores were averaged over the 4 week baseline period and the 4 week treatment periods.
Secondary	Percentage of Bowel Movements Preceded by Rectal Urgency	4 weeks baseline, 4 weeks treatment	Rectal urgency is defined as a sudden, irresistible need to have a bowel movement. Scores were averaged over the 4 week baseline period and the 4 week treatment periods.
Secondary	Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea	4 weeks baseline, 4 weeks treatment	The percentage of bowel movements with semi-formed and loose stools was defined as those with a score of 5-7 on the Bristol stool form scale.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Fecal Incontinence and Constipation Assessment (FICA) Score	4 weeks baseline, 4 weeks treatment	Intent to treat analysis	units on a scale	MEAN
SECONDARY	Mean Number of Days With Fecal Incontinence	4 weeks baseline, 4 weeks treatment	Intent to treat analysis	days	MEAN
SECONDARY	Mean Number of Fecal Incontinence Episodes	4 weeks baseline, 4 weeks treatment	Intent to treat analysis	number of episodes	MEAN
SECONDARY	Mean Percentage of Bowel Movements Which Were Incontinent	4 weeks baseline, 4 weeks treatment	Intent to treat analysis	percentage of bowel movements	MEAN
SECONDARY	Mean Severity of Fecal Incontinence	4 weeks baseline, 4 weeks treatment	Intent to treat analysis	units on a scale	MEAN
SECONDARY	Impact of Fecal Incontinence on Baseline Quality of Life	4 weeks baseline	Intent to treat analysis	units on a scale	MEAN
SECONDARY	Impact of Fecal Incontinence on Post-Treatment Quality of Life	after 4 weeks treatment	Intent to treat analysis	units on a scale	MEAN
SECONDARY	Satisfaction With Treatment	4 weeks baseline, 4 week treatment	Intent to treat analysis	units on a scale	MEAN
SECONDARY	Percentage of Bowel Movements Preceded by Rectal Urgency	4 weeks baseline, 4 weeks treatment	Intent to treat analysis	percentage of bowel movements	MEAN
SECONDARY	Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea	4 weeks baseline, 4 weeks treatment	Intent to treat analysis	percentage of bowel movements	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group68

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

Outcome	Group	Category	Value	Spread	Units
Mean Fecal Incontinence and Constipation Assessment (FICA) Score	Oral Clonidine	4 weeks baseline	8.1	Standard Error 0.4	units on a scale
Mean Fecal Incontinence and Constipation Assessment (FICA) Score	Oral Placebo	4 weeks baseline	9.1	Standard Error 0.3	units on a scale
Mean Fecal Incontinence and Constipation Assessment (FICA) Score	Oral Clonidine	4 weeks treatment	6.5	Standard Error 0.6	units on a scale
Mean Fecal Incontinence and Constipation Assessment (FICA) Score	Oral Placebo	4 weeks treatment	7.6	Standard Error 0.5	units on a scale
Mean Number of Days With Fecal Incontinence	Oral Clonidine	4 weeks baseline	13	Standard Error 1	days
Mean Number of Days With Fecal Incontinence	Oral Placebo	4 weeks baseline	16	Standard Error 2	days
Mean Number of Days With Fecal Incontinence	Oral Clonidine	4 weeks treatment	8	Standard Error 1	days
Mean Number of Days With Fecal Incontinence	Oral Placebo	4 weeks treatment	11	Standard Error 2	days
Mean Number of Fecal Incontinence Episodes	Oral Clonidine	4 weeks baseline	20	Standard Error 3	number of episodes
Mean Number of Fecal Incontinence Episodes	Oral Placebo	4 weeks baseline	31	Standard Error 5	number of episodes

1 to 10 of 68Source ClinicalTrials.gov

See all 68 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Oral Clonidine	22
Overall Study	STARTED	Oral Placebo	22
Overall Study	COMPLETED	Oral Clonidine	22
Overall Study	COMPLETED	Oral Placebo	21
Overall Study	NOT COMPLETED	Oral Clonidine	0
Overall Study	NOT COMPLETED	Oral Placebo	1

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	Dry Mouth	Gastrointestinal disorders	Oral Clonidine	16	22	16
other	Dry Mouth	Gastrointestinal disorders	Oral Placebo	1	22	1
other	Drowsiness	General disorders	Oral Clonidine	5	22	5
other	Drowsiness	General disorders	Oral Placebo	3	22	3
other	Lightheadedness	General disorders	Oral Clonidine	6	22	6
other	Lightheadedness	General disorders	Oral Placebo	2	22	2
other	Fatigue	General disorders	Oral Clonidine	8	22	8
other	Fatigue	General disorders	Oral Placebo	5	22	5

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Oral Clonidine
Total, all-cause mortality	Oral Placebo
Total, other adverse events	Oral Clonidine	19	22
Total, other adverse events	Oral Placebo	7	22
Total, serious adverse events	Oral Clonidine	0	22
Total, serious adverse events	Oral Placebo	0	22

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23891925	DERIVED

Source PubMed

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 comparisons1

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

Comparison
Oral Clonidine vs Oral Placebo: serious adverse events

Source 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.

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