Fecal Incontinence
Conditions
Keywords
fecal incontinence, stool leakage, incontinence, FI, Urge predominant fecal incontinence
Brief summary
Fecal incontinence is the involuntary leakage of stool from the anus. Doctors at Mayo Clinic are doing a research study to assess the effects of a medication, clonidine, on fecal incontinence and rectal functions in women. Clonidine has been approved by the Food and Drug Administration (FDA) for treating high blood pressure, but not for treating incontinence and rectal functions. The hypothesis of this study is clonidine will improve fecal incontinence, increase rectal capacity and reduce rectal sensation to a greater extent than placebo in women.
Detailed description
Available therapeutic options for idiopathic fecal incontinence (FI) are limited and unsatisfactory. In addition to weak anal sphincters, our data suggest that reduced rectal capacity may contribute to rectal hypersensitivity and the symptom of rectal urgency in FI. During a 4 week study, oral clonidine restored rectal capacity and improved fecal continence in women with urge-predominant FI. Clonidine improves fecal continence and stool consistency in diarrhea-predominant irritable bowel syndrome (IBS). Therefore, we now propose a placebo-controlled study of clonidine for FI. Our aims are to (i) compare the effects of clonidine and placebo, to be given for 4 weeks, on symptoms, anal pressures, rectal compliance and sensation in women with FI. Forty four women (18-75 y) with urge predominant idiopathic FI and ≥ 4 episodes of FI during a 4 week screening period will be recruited to this study. Thereafter, patients will be treated with clonidine or placebo for 4 weeks. Bowel symptoms will be recorded in a diary. Anal sphincter pressures, rectal compliance and sensation will be evaluated before and during treatment with clonidine.
Interventions
DRUGClonidine
Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
DRUGPlacebo
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 18-75 years with urge predominant FI, as defined by a validated questionnaire, for greater than or equal to 1 year duration will be eligible to participate * Absence of organic disease (i.e., ulcerative colitis, cancer) as evidenced by colonoscopy, or barium enema and sigmoidoscopy within the last 3 years
Exclusion criteria
* History of clinically significant cardiovascular or pulmonary disease or EKG abnormalities within the last 6 months \[i.e., atrial flutter or fibrillation, sinus tachycardia (\> 110/minute) or bradycardia (\< 45 beats/minute), or prolonged corrected QT (QTc) interval (\> 460 msec) * Current or past history of rectal cancer, scleroderma, inflammatory bowel disease, congenital anorectal abnormalities, greater than or equal to Grade 2 rectal prolapse, history of rectal resection or pelvic irradiation * Neurological disorders - Spinal cord injuries, dementia (Mini-mental status score \<20/25), multiple sclerosis, Parkinson's disease, peripheral neuropathy * Conditions precluding safe use of clonidine, i.e., symptomatic hypotension, or systolic blood pressure of \<100 mm Hg on initial screening visit * Pregnant or nursing women * Severe diarrhea during the run in phase defined as greater than 6 liquid stools daily (Bristol 6 or 7) * Medications: Absolute - opioid analgesics, anticholinergic drugs \[low doses of tricyclic antidepressants, e.g., nortriptyline (up to 50 mg/day) or amitriptyline (up to 25 mg/day) will be permitted provided they were begun 3 months prior to the screening period\] * Medications: Relative - other antihypertensive agents (i.e., if there is concern about synergistic effects and hypotension)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Fecal Incontinence Episodes | 4 weeks baseline, 4 weeks treatment | Values were averaged over 4 week baseline and 4 week treatment periods. |
| 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. |
| 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. |
| 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). |
| 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). |
| 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. |
| 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. |
| 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. |
| Percentage of Bowel Movements With Semi-formed and Loose Stools Post-treatment Adjusted for 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. The adjustment for baseline was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint. |
| Percentage of Days With Fecal Incontinence (FI) | 4 weeks baseline, 4 weeks treatment | — |
| Percentage of Days With FI Post-treatment Adjusted for Baseline | 4 weeks treatment | The adjustment for baseline was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint. |
| 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. |
Countries
United States
Participant flow
Recruitment details
This study was conducted between January 2009 and April 2012.
Participants by arm
| Arm | Count |
|---|---|
| Oral Clonidine Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks. | 22 |
| Oral Placebo 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. | 22 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Oral Clonidine | Oral Placebo | Total |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 10.88 | 57 years STANDARD_DEVIATION 11.86 | 57.38 years STANDARD_DEVIATION 11.26 |
| Body Mass Index | 30.3 kg/m^2 STANDARD_DEVIATION 1.09 | 28.0 kg/m^2 STANDARD_DEVIATION 6.35 | 29.14 kg/m^2 STANDARD_DEVIATION 5.81 |
| Functional diarrhea or Diarrhea-predominant Irritable Bowel Syndrome (IBS) Subjects with diarrhea | 9 participants | 13 participants | 22 participants |
| Functional diarrhea or Diarrhea-predominant Irritable Bowel Syndrome (IBS) Subjects without diarrhea | 13 participants | 9 participants | 22 participants |
| Hysterectomy Hysterectomy | 9 participants | 11 participants | 20 participants |
| Hysterectomy No Hysterectomy | 13 participants | 11 participants | 24 participants |
| Region of Enrollment United States | 22 participants | 22 participants | 44 participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 44 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 22 | 7 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Mean Fecal Incontinence and Constipation Assessment (FICA) Score
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
Population: Intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Clonidine | Mean Fecal Incontinence and Constipation Assessment (FICA) Score | 4 weeks baseline | 8.1 units on a scale | Standard Error 0.4 |
| Oral Clonidine | Mean Fecal Incontinence and Constipation Assessment (FICA) Score | 4 weeks treatment | 6.5 units on a scale | Standard Error 0.6 |
| Oral Placebo | Mean Fecal Incontinence and Constipation Assessment (FICA) Score | 4 weeks baseline | 9.1 units on a scale | Standard Error 0.3 |
| Oral Placebo | Mean Fecal Incontinence and Constipation Assessment (FICA) Score | 4 weeks treatment | 7.6 units on a scale | Standard Error 0.5 |
Secondary
Impact of Fecal Incontinence on Baseline Quality of Life
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
Population: Intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Clonidine | Impact of Fecal Incontinence on Baseline Quality of Life | Lifestyle score | 2.8 units on a scale | Standard Error 0.2 |
| Oral Clonidine | Impact of Fecal Incontinence on Baseline Quality of Life | Coping score | 1.8 units on a scale | Standard Error 0.1 |
| Oral Clonidine | Impact of Fecal Incontinence on Baseline Quality of Life | Depression score | 3.2 units on a scale | Standard Error 0.2 |
| Oral Clonidine | Impact of Fecal Incontinence on Baseline Quality of Life | Embarrassment score | 2.2 units on a scale | Standard Error 0.2 |
| Oral Placebo | Impact of Fecal Incontinence on Baseline Quality of Life | Embarrassment score | 2.3 units on a scale | Standard Error 0.2 |
| Oral Placebo | Impact of Fecal Incontinence on Baseline Quality of Life | Lifestyle score | 2.3 units on a scale | Standard Error 0.2 |
| Oral Placebo | Impact of Fecal Incontinence on Baseline Quality of Life | Depression score | 2.9 units on a scale | Standard Error 0.2 |
| Oral Placebo | Impact of Fecal Incontinence on Baseline Quality of Life | Coping score | 1.6 units on a scale | Standard Error 0.1 |
Secondary
Impact of Fecal Incontinence on Post-Treatment Quality of Life
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
Population: Intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Clonidine | Impact of Fecal Incontinence on Post-Treatment Quality of Life | Lifestyle score | 3.1 units on a scale | Standard Error 0.2 |
| Oral Clonidine | Impact of Fecal Incontinence on Post-Treatment Quality of Life | Coping score | 2.3 units on a scale | Standard Error 0.2 |
| Oral Clonidine | Impact of Fecal Incontinence on Post-Treatment Quality of Life | Depression score | 3.5 units on a scale | Standard Error 0.1 |
| Oral Clonidine | Impact of Fecal Incontinence on Post-Treatment Quality of Life | Embarrassment score | 2.8 units on a scale | Standard Error 0.2 |
| Oral Placebo | Impact of Fecal Incontinence on Post-Treatment Quality of Life | Embarrassment score | 2.5 units on a scale | Standard Error 0.2 |
| Oral Placebo | Impact of Fecal Incontinence on Post-Treatment Quality of Life | Lifestyle score | 2.7 units on a scale | Standard Error 0.2 |
| Oral Placebo | Impact of Fecal Incontinence on Post-Treatment Quality of Life | Depression score | 3.2 units on a scale | Standard Error 0.2 |
| Oral Placebo | Impact of Fecal Incontinence on Post-Treatment Quality of Life | Coping score | 2.1 units on a scale | Standard Error 0.1 |
Secondary
Mean Number of Days With Fecal Incontinence
Values were averaged over 4 week baseline and 4 week treatment periods.
Time frame: 4 weeks baseline, 4 weeks treatment
Population: Intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Clonidine | Mean Number of Days With Fecal Incontinence | 4 weeks baseline | 13 days | Standard Error 1 |
| Oral Clonidine | Mean Number of Days With Fecal Incontinence | 4 weeks treatment | 8 days | Standard Error 1 |
| Oral Placebo | Mean Number of Days With Fecal Incontinence | 4 weeks baseline | 16 days | Standard Error 2 |
| Oral Placebo | Mean Number of Days With Fecal Incontinence | 4 weeks treatment | 11 days | Standard Error 2 |
Secondary
Mean Number of Fecal Incontinence Episodes
Values were averaged over 4 week baseline and 4 week treatment periods.
Time frame: 4 weeks baseline, 4 weeks treatment
Population: Intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Clonidine | Mean Number of Fecal Incontinence Episodes | 4 weeks baseline | 20 number of episodes | Standard Error 3 |
| Oral Clonidine | Mean Number of Fecal Incontinence Episodes | 4 weeks treatment | 12 number of episodes | Standard Error 3 |
| Oral Placebo | Mean Number of Fecal Incontinence Episodes | 4 weeks baseline | 31 number of episodes | Standard Error 5 |
| Oral Placebo | Mean Number of Fecal Incontinence Episodes | 4 weeks treatment | 19 number of episodes | Standard Error 4 |
Secondary
Mean Percentage of Bowel Movements Which Were Incontinent
Values were averaged over 4 week baseline and 4 week treatment periods.
Time frame: 4 weeks baseline, 4 weeks treatment
Population: Intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Clonidine | Mean Percentage of Bowel Movements Which Were Incontinent | 4 weeks baseline | 31 percentage of bowel movements | Standard Error 4 |
| Oral Clonidine | Mean Percentage of Bowel Movements Which Were Incontinent | 4 weeks treatment | 24 percentage of bowel movements | Standard Error 5 |
| Oral Placebo | Mean Percentage of Bowel Movements Which Were Incontinent | 4 weeks treatment | 27 percentage of bowel movements | Standard Error 6 |
| Oral Placebo | Mean Percentage of Bowel Movements Which Were Incontinent | 4 weeks baseline | 40 percentage of bowel movements | Standard Error 6 |
Secondary
Mean Severity of Fecal Incontinence
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
Population: Intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Clonidine | Mean Severity of Fecal Incontinence | 4 weeks baseline | 36.2 units on a scale | Standard Error 2.7 |
| Oral Clonidine | Mean Severity of Fecal Incontinence | 4 weeks treatment | 29.3 units on a scale | Standard Error 2.8 |
| Oral Placebo | Mean Severity of Fecal Incontinence | 4 weeks baseline | 37.3 units on a scale | Standard Error 2.5 |
| Oral Placebo | Mean Severity of Fecal Incontinence | 4 weeks treatment | 31.2 units on a scale | Standard Error 2.7 |
Secondary
Percentage of Bowel Movements Preceded by Rectal Urgency
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
Population: Intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Clonidine | Percentage of Bowel Movements Preceded by Rectal Urgency | 4 weeks baseline | 55 percentage of bowel movements | Standard Error 4 |
| Oral Clonidine | Percentage of Bowel Movements Preceded by Rectal Urgency | 4 weeks treatment | 46 percentage of bowel movements | Standard Error 6 |
| Oral Placebo | Percentage of Bowel Movements Preceded by Rectal Urgency | 4 weeks baseline | 59 percentage of bowel movements | Standard Error 5 |
| Oral Placebo | Percentage of Bowel Movements Preceded by Rectal Urgency | 4 weeks treatment | 46 percentage of bowel movements | Standard Error 6 |
Secondary
Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea
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
Population: Intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Clonidine | Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea | 4 weeks baseline, subjects without diarrhea | 19.4 percentage of bowel movements | Standard Error 4.9 |
| Oral Clonidine | Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea | 4 weeks treatment, subjects without diarrhea | 14 percentage of bowel movements | Standard Error 4.2 |
| Oral Clonidine | Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea | 4 weeks baseline, subjects with diarrhea | 47.5 percentage of bowel movements | Standard Error 8.1 |
| Oral Clonidine | Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea | 4 weeks treatment, subjects with diarrhea | 31.2 percentage of bowel movements | Standard Error 7 |
| Oral Placebo | Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea | 4 weeks baseline, subjects with diarrhea | 51.6 percentage of bowel movements | Standard Error 6.4 |
| Oral Placebo | Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea | 4 weeks baseline, subjects without diarrhea | 25.5 percentage of bowel movements | Standard Error 6.2 |
| Oral Placebo | Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea | 4 weeks treatment, subjects with diarrhea | 49 percentage of bowel movements | Standard Error 5.5 |
| Oral Placebo | Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea | 4 weeks treatment, subjects without diarrhea | 16 percentage of bowel movements | Standard Error 7.2 |
Comparison: Proportion of semi-formed and loose stools (Bristol Form 5-7) associated with diarrhea subgroup versus no diarrhea subgroup.p-value: <0.001ANCOVA
Secondary
Percentage of Bowel Movements With Semi-formed and Loose Stools Post-treatment Adjusted for Baseline
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
Population: Intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Clonidine | Percentage of Bowel Movements With Semi-formed and Loose Stools Post-treatment Adjusted for Baseline | Subjects with diarrhea | 23.6 percentage of bowel movements | Standard Error 4.8 |
| Oral Clonidine | Percentage of Bowel Movements With Semi-formed and Loose Stools Post-treatment Adjusted for Baseline | Subjects without diarrhea | 25.4 percentage of bowel movements | Standard Error 4.3 |
| Oral Placebo | Percentage of Bowel Movements With Semi-formed and Loose Stools Post-treatment Adjusted for Baseline | Subjects with diarrhea | 38.7 percentage of bowel movements | Standard Error 4.3 |
| Oral Placebo | Percentage of Bowel Movements With Semi-formed and Loose Stools Post-treatment Adjusted for Baseline | Subjects without diarrhea | 22.8 percentage of bowel movements | Standard Error 4.8 |
p-value: 0.018ANCOVA
Comparison: drug\*group interactionsp-value: 0.047ANCOVA
Secondary
Percentage of Days With Fecal Incontinence (FI)
Time frame: 4 weeks baseline, 4 weeks treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Clonidine | Percentage of Days With Fecal Incontinence (FI) | 4 weeks baseline, subjects without diarrhea | 28.7 percentage of days | Standard Error 5.5 |
| Oral Clonidine | Percentage of Days With Fecal Incontinence (FI) | 4 weeks baseline, subjects with diarrhea | 35.4 percentage of days | Standard Error 7.2 |
| Oral Clonidine | Percentage of Days With Fecal Incontinence (FI) | 4 weeks treatment, subjects without diarrhea | 23.2 percentage of days | Standard Error 7.1 |
| Oral Clonidine | Percentage of Days With Fecal Incontinence (FI) | 4 weeks treatment, subjects with diarrhea | 24.3 percentage of days | Standard Error 8.5 |
| Oral Placebo | Percentage of Days With Fecal Incontinence (FI) | 4 weeks treatment, subjects with diarrhea | 33.3 percentage of days | Standard Error 9.8 |
| Oral Placebo | Percentage of Days With Fecal Incontinence (FI) | 4 weeks baseline, subjects without diarrhea | 37.8 percentage of days | Standard Error 10.6 |
| Oral Placebo | Percentage of Days With Fecal Incontinence (FI) | 4 weeks treatment, subjects without diarrhea | 18.7 percentage of days | Standard Error 5.4 |
| Oral Placebo | Percentage of Days With Fecal Incontinence (FI) | 4 weeks baseline, subjects with diarrhea | 42.1 percentage of days | Standard Error 8.1 |
Secondary
Percentage of Days With FI Post-treatment Adjusted for Baseline
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Clonidine | Percentage of Days With FI Post-treatment Adjusted for Baseline | Subjects without diarrhea | 42.54 percentage of days | Standard Error 5.92 |
| Oral Clonidine | Percentage of Days With FI Post-treatment Adjusted for Baseline | Subjects with diarrhea | 27.79 percentage of days | Standard Error 6.97 |
| Oral Placebo | Percentage of Days With FI Post-treatment Adjusted for Baseline | Subjects without diarrhea | 31.42 percentage of days | Standard Error 6.97 |
| Oral Placebo | Percentage of Days With FI Post-treatment Adjusted for Baseline | Subjects with diarrhea | 39.51 percentage of days | Standard Error 5.94 |
p-value: 0.082ANCOVA
Secondary
Satisfaction With 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.
Time frame: 4 weeks baseline, 4 week treatment
Population: Intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Clonidine | Satisfaction With Treatment | 4 weeks baseline | 22 units on a scale | Standard Error 6 |
| Oral Clonidine | Satisfaction With Treatment | 4 weeks treatment | 47 units on a scale | Standard Error 6 |
| Oral Placebo | Satisfaction With Treatment | 4 weeks baseline | 18 units on a scale | Standard Error 4 |
| Oral Placebo | Satisfaction With Treatment | 4 weeks treatment | 38 units on a scale | Standard Error 6 |