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Poor enrollment; funding ending Dec 31, 2018.
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| Name | Class |
|---|---|
| Consortium of Multiple Sclerosis Centers | OTHER |
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The investigators seek to test whether incorporating the scheduled dosing of a bisacodyl 10 mg rectal suppository every other day improves bowel-related symptoms in patients with multiple sclerosis. Patients will be randomized to receive either a placebo suppository or bisacodyl suppository dosed every other day for 4 weeks.
The majority of patients with multiple sclerosis (MS) suffer from some form of anorectal dysfunction, and these difficulties with bowel function are often ranked as negatively impactful on quality of life as impaired mobility. Despite the significant clinical burden of these symptoms, there remains a paucity of published literature supporting specific therapeutic options to manage anorectal dysfunction in this clinical population. Most bowel regimens rely on either oral laxatives (i.e. PEG-3350) or anti-diarrheal agents (i.e. loperamide). In their study, the investigators propose to establish the efficacy of a bowel regimen that combines both oral agents (as needed; standard care) with scheduled, every other day dosing of a placebo or stimulant laxative rectal suppository -- bisacodyl 10 mg.
Bisacodyl is a stimulant laxative medication that is available over-the-counter. It works by activating nerves in the rectum to elicit rectal contractions which ultimately leading to defecation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Every other day placement of a placebo rectal suppository for 4 weeks |
|
| Bisacodyl | Experimental | Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bisacodyl | Drug | Rectal suppository |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 30% Improvement From Baseline in Bowel Symptoms at 4 Weeks | All subjects were asked the following question at study entry ('baseline') and the end of 4 weeks of intervention: "Using a scale of 1 to 10 (1 being no problem and 10 being maximally impactful symptoms), how would you rate the severity of your bowel symptoms over the past 2 weeks?" The range of reported values was 2-9. We took a response to be a 30% decrease (i.e. improvement) in the subjective symptom score between the baseline and 4 week assessment. | Baseline, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean PAC-SYM Subscale Scores at 4 Weeks | The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) is a validated measure of constipation severity. The questionnaire has a total score and three subscales: Abdominal Symptoms, Rectal Symptoms, and Stool Form. The mean total score and each of the scale subscores are reported in a range of 0-4, with higher scores meaning worse outcomes. A difference (number) of 0.75 in the mean PAC-SYM total and each of the subscale scores is regarded as a clinically significant change. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J Levinthal, MD, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Every other day placement of a placebo rectal suppository for 4 weeks Placebo: Rectal suppository |
| FG001 | Bisacodyl | Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks Bisacodyl: Rectal suppository |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Every other day placement of a placebo rectal suppository for 4 weeks Placebo: Rectal suppository |
| BG001 | Bisacodyl | Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks Bisacodyl: Rectal suppository |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With 30% Improvement From Baseline in Bowel Symptoms at 4 Weeks | All subjects were asked the following question at study entry ('baseline') and the end of 4 weeks of intervention: "Using a scale of 1 to 10 (1 being no problem and 10 being maximally impactful symptoms), how would you rate the severity of your bowel symptoms over the past 2 weeks?" The range of reported values was 2-9. We took a response to be a 30% decrease (i.e. improvement) in the subjective symptom score between the baseline and 4 week assessment. | Posted | Count of Participants | Participants | Baseline, 4 weeks |
|
During trial duration (4 weeks)
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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 | Placebo | Every other day placement of a placebo rectal suppository for 4 weeks Placebo: Rectal suppository |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal cramps | Gastrointestinal disorders | Non-systematic Assessment |
Early Termination due to Difficulty in Recruitment, leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Levinthal | University of Pittsburgh Medical Center | 14123030525 | levinthald@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2018 | Dec 17, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D005242 | Fecal Incontinence |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D001726 | Bisacodyl |
| ID | Term |
|---|---|
| D003408 | Cresols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo | Other | Rectal suppository |
|
| Baseline, 4 weeks |
| Change From Baseline in Fecal Incontinence Severity Index (FISI) Score at 4 Weeks | The Fecal Incontinence Severity Index (FISI) is measures of fecal incontinence severity. The FISI score ranges from 0 to 61, with higher scores interpreted as worse fecal incontinence severity. | Baseline, 4 Weeks |
| Change From Baseline in Fecal Incontinence Quality of Life (FIQL) Score at 4 Weeks | The Fecal Incontinence Quality of Life (FIQL) Scale measures of the impact of fecal incontinence on aspects of quality of life. There are 4 subscales: Lifestyle, Coping/Behavior, Depression/Self-Perception, and Embarrassment, each of which is calculated as an average score ranging from 1 to 5, with higher scores indicating a greater functional status of quality of life. | Baseline, 4 weeks |
| Change From Baseline in PAC-QOL Scores at 4 Weeks | The Patient Assessment of Constipation Quality of Life (PAC-QOL) Questionnaire is a validated measure of the quality of life impact of constipation. The questionnaire is reported a total score, reported as the average item scores and ranging from 0 to 4, where higher scores represent poorer QOL. | Baseline, 4 weeks |
| Change From Baseline in SF-36 Scores at 4 Weeks | The RAND Health Survey (v.1) is a 36 item questionnaire that measures health in multiple domains. The measure is reported as scores on eight subscales: Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Energy/fatigue, Emotional well-being, Social functioning, Pain, and General health. Scores on each subscale range from 0 and 100, with higher scores indicative of better health function in the domain. | Baseline, 4 weeks |
| Change From Baseline In Percent of Subjects With Normal Average Stool Form at 4 Weeks | The Bristol Stool Scale (BSS) is a validated measure of stool form, ranging from 1-7. Normal stool form is regarded as average scores of 3 to 4. Subjects were asked to assess the BSS in their 'bowel diaries' during a preparatory phase of up to 4 weeks prior to study entry and for 4 weeks after intervention, but these 'bowel diaries' were not required for entry into the trial. | Baseline, 4 weeks |
| Change From Baseline In Average Number of Daily Bowel Movements at 4 Weeks | Subjects were asked to record each bowel movement in their 'bowel diaries' during a preparatory phase of up to 4 weeks prior to study entry and for 4 weeks after intervention. We used this information to calculate the average difference in number of bowel movements / day before and after exposure to placebo or Bisacodyl. However, these 'bowel diaries' were not required for entry into the trial. Thus, comparative data for bowel movement frequency was available for 3 of the 6 subjects randomized to placebo, and 2 of the 4 subjects randomized to receive Bisacodyl. | Baseline, 4 weeks |
| Change From Baseline In Average Number of Fecal Incontinence Episodes at 4 Weeks | Subjects were asked to record each episode of fecal incontinence in their 'bowel diaries' during a preparatory phase of up to 4 weeks prior to study entry and for 4 weeks after intervention. We used this information to calculate the mean difference in the average number of fecal incontinence episodes / day. | Baseline, 4 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks Bisacodyl: Rectal suppository |
|
|
| Secondary | Change From Baseline in Mean PAC-SYM Subscale Scores at 4 Weeks | The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) is a validated measure of constipation severity. The questionnaire has a total score and three subscales: Abdominal Symptoms, Rectal Symptoms, and Stool Form. The mean total score and each of the scale subscores are reported in a range of 0-4, with higher scores meaning worse outcomes. A difference (number) of 0.75 in the mean PAC-SYM total and each of the subscale scores is regarded as a clinically significant change. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | Change From Baseline in Fecal Incontinence Severity Index (FISI) Score at 4 Weeks | The Fecal Incontinence Severity Index (FISI) is measures of fecal incontinence severity. The FISI score ranges from 0 to 61, with higher scores interpreted as worse fecal incontinence severity. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 Weeks |
|
|
|
| Secondary | Change From Baseline in Fecal Incontinence Quality of Life (FIQL) Score at 4 Weeks | The Fecal Incontinence Quality of Life (FIQL) Scale measures of the impact of fecal incontinence on aspects of quality of life. There are 4 subscales: Lifestyle, Coping/Behavior, Depression/Self-Perception, and Embarrassment, each of which is calculated as an average score ranging from 1 to 5, with higher scores indicating a greater functional status of quality of life. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | Change From Baseline in PAC-QOL Scores at 4 Weeks | The Patient Assessment of Constipation Quality of Life (PAC-QOL) Questionnaire is a validated measure of the quality of life impact of constipation. The questionnaire is reported a total score, reported as the average item scores and ranging from 0 to 4, where higher scores represent poorer QOL. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | Change From Baseline in SF-36 Scores at 4 Weeks | The RAND Health Survey (v.1) is a 36 item questionnaire that measures health in multiple domains. The measure is reported as scores on eight subscales: Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Energy/fatigue, Emotional well-being, Social functioning, Pain, and General health. Scores on each subscale range from 0 and 100, with higher scores indicative of better health function in the domain. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | Change From Baseline In Percent of Subjects With Normal Average Stool Form at 4 Weeks | The Bristol Stool Scale (BSS) is a validated measure of stool form, ranging from 1-7. Normal stool form is regarded as average scores of 3 to 4. Subjects were asked to assess the BSS in their 'bowel diaries' during a preparatory phase of up to 4 weeks prior to study entry and for 4 weeks after intervention, but these 'bowel diaries' were not required for entry into the trial. | Comparative data was available for only 3 of the 6 subjects randomized to placebo, and only 1 of the 4 subjects randomized to receive Bisacodyl. | Posted | Number | percentage of participants | Baseline, 4 weeks |
|
|
|
| Secondary | Change From Baseline In Average Number of Daily Bowel Movements at 4 Weeks | Subjects were asked to record each bowel movement in their 'bowel diaries' during a preparatory phase of up to 4 weeks prior to study entry and for 4 weeks after intervention. We used this information to calculate the average difference in number of bowel movements / day before and after exposure to placebo or Bisacodyl. However, these 'bowel diaries' were not required for entry into the trial. Thus, comparative data for bowel movement frequency was available for 3 of the 6 subjects randomized to placebo, and 2 of the 4 subjects randomized to receive Bisacodyl. | These 'bowel diaries' were not required for entry into the trial. Thus, comparative data for bowel movement frequency was available for 3 of the 6 subjects randomized to placebo, and 2 of the 4 subjects randomized to receive Bisacodyl. | Posted | Mean | Standard Deviation | bowel movements per day | Baseline, 4 weeks |
|
|
|
| Secondary | Change From Baseline In Average Number of Fecal Incontinence Episodes at 4 Weeks | Subjects were asked to record each episode of fecal incontinence in their 'bowel diaries' during a preparatory phase of up to 4 weeks prior to study entry and for 4 weeks after intervention. We used this information to calculate the mean difference in the average number of fecal incontinence episodes / day. | These 'bowel diaries' were not required for entry into the trial. Thus, comparative data for bowel movement frequency was available for 3 of the 6 subjects randomized to placebo, and 2 of the 4 subjects randomized to receive Bisacodyl. | Posted | Mean | Standard Deviation | incontinence episodes per day | Baseline, 4 weeks |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Bisacodyl | Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks Bisacodyl: Rectal suppository | 0 | 5 | 0 | 5 | 1 | 5 |
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| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| Change in Rectal Subscale |
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| Stool Subscale |
|
| Depression/ Self-Perception |
|
| Embarrassment |
|
| Role limitations due to emotional problems |
|
| Energy/fatigue |
|
| Emotional well-being |
|
| Social functioning |
|
| Pain |
|
| General health |
|