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A Placebo-Controlled Study of Clonidine for Fecal Incontinence.

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ClinicalTrials.gov Identifier: NCT00884832
Recruitment Status : Completed
First Posted : April 21, 2009
Results First Posted : March 6, 2014
Last Update Posted : March 6, 2014
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Adil Bharucha, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Fecal Incontinence
Interventions Drug: Clonidine
Drug: Placebo
Enrollment 44
Recruitment Details This study was conducted between January 2009 and April 2012.
Pre-assignment Details  
Arm/Group Title Oral Clonidine Oral Placebo
Hide Arm/Group Description Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks. Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
Period Title: Overall Study
Started 22 22
Completed 22 21
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title Oral Clonidine Oral Placebo Total
Hide Arm/Group Description Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks. Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 22 22 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 22 participants 44 participants
58  (10.88) 57  (11.86) 57.38  (11.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Female
22
 100.0%
22
 100.0%
44
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 22 participants 44 participants
22 22 44
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 22 participants 22 participants 44 participants
30.3  (1.09) 28.0  (6.35) 29.14  (5.81)
Hysterectomy   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Hysterectomy 9 11 20
No Hysterectomy 13 11 24
[1]
Measure Description: Number of participants who had previously had a hysterectomy at baseline.
Functional diarrhea or Diarrhea-predominant Irritable Bowel Syndrome (IBS)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Subjects with diarrhea 9 13 22
Subjects without diarrhea 13 9 22
1.Primary Outcome
Title Mean Fecal Incontinence and Constipation Assessment (FICA) Score
Hide Description 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.
Time Frame 4 weeks baseline, 4 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis
Arm/Group Title Oral Clonidine Oral Placebo
Hide Arm/Group Description:
Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
Overall Number of Participants Analyzed 22 22
Mean (Standard Error)
Unit of Measure: units on a scale
4 weeks baseline 8.1  (0.4) 9.1  (0.3)
4 weeks treatment 6.5  (0.6) 7.6  (0.5)
2.Secondary Outcome
Title Mean Number of Days With Fecal Incontinence
Hide Description Values were averaged over 4 week baseline and 4 week treatment periods.
Time Frame 4 weeks baseline, 4 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis
Arm/Group Title Oral Clonidine Oral Placebo
Hide Arm/Group Description:
Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
Overall Number of Participants Analyzed 22 22
Mean (Standard Error)
Unit of Measure: days
4 weeks baseline 13  (1) 16  (2)
4 weeks treatment 8  (1) 11  (2)
3.Secondary Outcome
Title Mean Number of Fecal Incontinence Episodes
Hide Description Values were averaged over 4 week baseline and 4 week treatment periods.
Time Frame 4 weeks baseline, 4 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis
Arm/Group Title Oral Clonidine Oral Placebo
Hide Arm/Group Description:
Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
Overall Number of Participants Analyzed 22 22
Mean (Standard Error)
Unit of Measure: number of episodes
4 weeks baseline 20  (3) 31  (5)
4 weeks treatment 12  (3) 19  (4)
4.Secondary Outcome
Title Mean Percentage of Bowel Movements Which Were Incontinent
Hide Description Values were averaged over 4 week baseline and 4 week treatment periods.
Time Frame 4 weeks baseline, 4 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis
Arm/Group Title Oral Clonidine Oral Placebo
Hide Arm/Group Description:
Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
Overall Number of Participants Analyzed 22 22
Mean (Standard Error)
Unit of Measure: percentage of bowel movements
4 weeks baseline 31  (4) 40  (6)
4 weeks treatment 24  (5) 27  (6)
5.Secondary Outcome
Title Mean Severity of Fecal Incontinence
Hide Description 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.
Time Frame 4 weeks baseline, 4 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis
Arm/Group Title Oral Clonidine Oral Placebo
Hide Arm/Group Description:
Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
Overall Number of Participants Analyzed 22 22
Mean (Standard Error)
Unit of Measure: units on a scale
4 weeks baseline 36.2  (2.7) 37.3  (2.5)
4 weeks treatment 29.3  (2.8) 31.2  (2.7)
6.Secondary Outcome
Title Impact of Fecal Incontinence on Baseline Quality of Life
Hide Description

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).

Time Frame 4 weeks baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis
Arm/Group Title Oral Clonidine Oral Placebo
Hide Arm/Group Description:
Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
Overall Number of Participants Analyzed 22 22
Mean (Standard Error)
Unit of Measure: units on a scale
Lifestyle score 2.8  (0.2) 2.3  (0.2)
Coping score 1.8  (0.1) 1.6  (0.1)
Depression score 3.2  (0.2) 2.9  (0.2)
Embarrassment score 2.2  (0.2) 2.3  (0.2)
7.Secondary Outcome
Title Impact of Fecal Incontinence on Post-Treatment Quality of Life
Hide Description

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).

Time Frame after 4 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis
Arm/Group Title Oral Clonidine Oral Placebo
Hide Arm/Group Description:
Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
Overall Number of Participants Analyzed 22 22
Mean (Standard Error)
Unit of Measure: units on a scale
Lifestyle score 3.1  (0.2) 2.7  (0.2)
Coping score 2.3  (0.2) 2.1  (0.1)
Depression score 3.5  (0.1) 3.2  (0.2)
Embarrassment score 2.8  (0.2) 2.5  (0.2)
8.Secondary Outcome
Title Satisfaction With Treatment
Hide Description 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.
Time Frame 4 weeks baseline, 4 week treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis
Arm/Group Title Oral Clonidine Oral Placebo
Hide Arm/Group Description:
Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
Overall Number of Participants Analyzed 22 22
Mean (Standard Error)
Unit of Measure: units on a scale
4 weeks baseline 22  (6) 18  (4)
4 weeks treatment 47  (6) 38  (6)
9.Secondary Outcome
Title Percentage of Bowel Movements Preceded by Rectal Urgency
Hide Description 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.
Time Frame 4 weeks baseline, 4 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis
Arm/Group Title Oral Clonidine Oral Placebo
Hide Arm/Group Description:
Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
Overall Number of Participants Analyzed 22 22
Mean (Standard Error)
Unit of Measure: percentage of bowel movements
4 weeks baseline 55  (4) 59  (5)
4 weeks treatment 46  (6) 46  (6)
10.Secondary Outcome
Title Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea
Hide Description 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.
Time Frame 4 weeks baseline, 4 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis
Arm/Group Title Oral Clonidine Oral Placebo
Hide Arm/Group Description:
Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
Overall Number of Participants Analyzed 22 22
Mean (Standard Error)
Unit of Measure: percentage of bowel movements
4 weeks baseline, subjects without diarrhea 19.4  (4.9) 25.5  (6.2)
4 weeks baseline, subjects with diarrhea 47.5  (8.1) 51.6  (6.4)
4 weeks treatment, subjects without diarrhea 14  (4.2) 16  (7.2)
4 weeks treatment, subjects with diarrhea 31.2  (7) 49  (5.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oral Clonidine, Oral Placebo
Comments Proportion of semi-formed and loose stools (Bristol Form 5-7) associated with diarrhea subgroup versus no diarrhea subgroup.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Bowel Movements With Semi-formed and Loose Stools Post-treatment Adjusted for Baseline
Hide Description 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. The “adjustment for baseline” was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint.
Time Frame 4 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis
Arm/Group Title Oral Clonidine Oral Placebo
Hide Arm/Group Description:
Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
Overall Number of Participants Analyzed 22 22
Mean (Standard Error)
Unit of Measure: percentage of bowel movements
Subjects with diarrhea 23.6  (4.8) 38.7  (4.3)
Subjects without diarrhea 25.4  (4.3) 22.8  (4.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oral Clonidine, Oral Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oral Clonidine, Oral Placebo
Comments drug*group interactions
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Days With Fecal Incontinence (FI)
Hide Description [Not Specified]
Time Frame 4 weeks baseline, 4 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Clonidine Oral Placebo
Hide Arm/Group Description:
Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
Overall Number of Participants Analyzed 22 22
Mean (Standard Error)
Unit of Measure: percentage of days
4 weeks baseline, subjects without diarrhea 28.7  (5.5) 37.8  (10.6)
4 weeks baseline, subjects with diarrhea 35.4  (7.2) 42.1  (8.1)
4 weeks treatment, subjects without diarrhea 23.2  (7.1) 18.7  (5.4)
4 weeks treatment, subjects with diarrhea 24.3  (8.5) 33.3  (9.8)
13.Secondary Outcome
Title Percentage of Days With FI Post-treatment Adjusted for Baseline
Hide Description The “adjustment for baseline” was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint.
Time Frame 4 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Clonidine Oral Placebo
Hide Arm/Group Description:
Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
Overall Number of Participants Analyzed 22 22
Mean (Standard Error)
Unit of Measure: percentage of days
Subjects without diarrhea 42.54  (5.92) 31.42  (6.97)
Subjects with diarrhea 27.79  (6.97) 39.51  (5.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oral Clonidine, Oral Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.082
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oral Clonidine Oral Placebo
Hide Arm/Group Description Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks. Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
All-Cause Mortality
Oral Clonidine Oral Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Oral Clonidine Oral Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/22 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oral Clonidine Oral Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/22 (86.36%)      7/22 (31.82%)    
Gastrointestinal disorders     
Dry Mouth   16/22 (72.73%)  16 1/22 (4.55%)  1
General disorders     
Drowsiness   5/22 (22.73%)  5 3/22 (13.64%)  3
Lightheadedness   6/22 (27.27%)  6 2/22 (9.09%)  2
Fatigue   8/22 (36.36%)  8 5/22 (22.73%)  5
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Adil E. Bharucha
Organization: Mayo Clinic
Phone: 507-266-9156
EMail: bharucha.adil@mayo.edu
Layout table for additonal information
Responsible Party: Adil Bharucha, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00884832     History of Changes
Other Study ID Numbers: 08-005892
R01DK078924 ( U.S. NIH Grant/Contract )
UL1RR024150 ( U.S. NIH Grant/Contract )
First Submitted: April 17, 2009
First Posted: April 21, 2009
Results First Submitted: October 16, 2013
Results First Posted: March 6, 2014
Last Update Posted: March 6, 2014