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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK078924 | U.S. NIH Grant/Contract | View source | |
| UL1RR024150 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| National Center for Research Resources (NCRR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Clonidine | Experimental | Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks. |
|
| Oral Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine | Drug | Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks baseline, 4 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Days With Fecal Incontinence | Values were averaged over 4 week baseline and 4 week treatment periods. | 4 weeks baseline, 4 weeks treatment |
| Mean Number of Fecal Incontinence Episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adil E Bharucha, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23891925 | Derived | Bharucha AE, Fletcher JG, Camilleri M, Edge J, Carlson P, Zinsmeister AR. Effects of clonidine in women with fecal incontinence. Clin Gastroenterol Hepatol. 2014 May;12(5):843-851.e2; quiz e44. doi: 10.1016/j.cgh.2013.06.035. Epub 2013 Jul 23. |
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This study was conducted between January 2009 and April 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Clonidine | Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Clonidine | Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent to treat analysis | Posted | Mean | Standard Error | units on a scale | 4 weeks baseline, 4 weeks treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Clonidine | Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adil E. Bharucha | Mayo Clinic | 507-266-9156 | bharucha.adil@mayo.edu |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Placebo | Drug | 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. |
|
Values were averaged over 4 week baseline and 4 week treatment periods.
| 4 weeks baseline, 4 weeks treatment |
| Mean Percentage of Bowel Movements Which Were Incontinent | Values were averaged over 4 week baseline and 4 week treatment periods. | 4 weeks baseline, 4 weeks treatment |
| 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. | 4 weeks baseline, 4 weeks treatment |
| 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). | 4 weeks baseline |
| 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). | after 4 weeks treatment |
| 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. | 4 weeks baseline, 4 week treatment |
| 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. | 4 weeks baseline, 4 weeks treatment |
| 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. | 4 weeks baseline, 4 weeks treatment |
| 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. | 4 weeks treatment |
| Percentage of Days With Fecal Incontinence (FI) | 4 weeks baseline, 4 weeks treatment |
| 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. | 4 weeks treatment |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Hysterectomy | Number of participants who had previously had a hysterectomy at baseline. | Number | participants |
|
| Functional diarrhea or Diarrhea-predominant Irritable Bowel Syndrome (IBS) | Number | participants |
|
| 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. |
|
|
| Secondary | Mean Number of Days With Fecal Incontinence | Values were averaged over 4 week baseline and 4 week treatment periods. | Intent to treat analysis | Posted | Mean | Standard Error | days | 4 weeks baseline, 4 weeks treatment |
|
|
|
| Secondary | Mean Number of Fecal Incontinence Episodes | Values were averaged over 4 week baseline and 4 week treatment periods. | Intent to treat analysis | Posted | Mean | Standard Error | number of episodes | 4 weeks baseline, 4 weeks treatment |
|
|
|
| Secondary | Mean Percentage of Bowel Movements Which Were Incontinent | Values were averaged over 4 week baseline and 4 week treatment periods. | Intent to treat analysis | Posted | Mean | Standard Error | percentage of bowel movements | 4 weeks baseline, 4 weeks treatment |
|
|
|
| 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. | Intent to treat analysis | Posted | Mean | Standard Error | units on a scale | 4 weeks baseline, 4 weeks treatment |
|
|
|
| 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). | Intent to treat analysis | Posted | Mean | Standard Error | units on a scale | 4 weeks baseline |
|
|
|
| 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). | Intent to treat analysis | Posted | Mean | Standard Error | units on a scale | after 4 weeks treatment |
|
|
|
| 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. | Intent to treat analysis | Posted | Mean | Standard Error | units on a scale | 4 weeks baseline, 4 week treatment |
|
|
|
| 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. | Intent to treat analysis | Posted | Mean | Standard Error | percentage of bowel movements | 4 weeks baseline, 4 weeks treatment |
|
|
|
| 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. | Intent to treat analysis | Posted | Mean | Standard Error | percentage of bowel movements | 4 weeks baseline, 4 weeks treatment |
|
|
|
|
| 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. | Intent to treat analysis | Posted | Mean | Standard Error | percentage of bowel movements | 4 weeks treatment |
|
|
|
|
| Secondary | Percentage of Days With Fecal Incontinence (FI) | Posted | Mean | Standard Error | percentage of days | 4 weeks baseline, 4 weeks treatment |
|
|
|
| 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. | Posted | Mean | Standard Error | percentage of days | 4 weeks treatment |
|
|
|
|
| 0 |
| 22 |
| 19 |
| 22 |
| EG001 | 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. | 0 | 22 | 7 | 22 |
| Drowsiness | General disorders | Systematic Assessment |
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| Lightheadedness | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
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| D006571 |
| Heterocyclic Compounds |
| Depression score |
|
| Embarrassment score |
|
| Depression score |
|
| Embarrassment score |
|
| 4 weeks treatment, subjects without diarrhea |
|
| 4 weeks treatment, subjects with diarrhea |
|
| 95 |
| No |
| Superiority or Other |
| 4 weeks treatment, subjects without diarrhea |
|
| 4 weeks treatment, subjects with diarrhea |
|