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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02609607 |
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Date of registration:
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16/11/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Treating Anorectal Dysfunction in MS
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Scientific title:
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Treating Anorectal Dysfunction Associated With Multiple Sclerosis |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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11 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02609607 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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David J Levinthal, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pittsburgh |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- MS patients with mild to moderately severe disease (Multiple Sclerosis Impact Scale
[MSIS-29] physical domain scores <61 or equivalent Extended Disability Severity Score
[EDSS] < 6.5) of any age, gender, disease subtype, duration of illness, current use of
MS disease modifying therapy, or comorbid medical condition AND who also have
anorectal dysfunction (chronic constipation and/or fecal incontinence) are eligible.
Exclusion Criteria:
- MS patients with severe disease (MSIS-29 physical domain scores greater than 61 or
equivalently severe EDSS greater than 6.5), patients with surgically altered anorectal
anatomy (i.e. proctectomy/partial colectomy, ostomy creation), active enteric
infection (i.e., Clostidium Difficile), or inflammatory bowel disease (i.e. ulcerative
proctitis, ulcerative colitis) will also be excluded.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Constipation
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Fecal Incontinence
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Intervention(s)
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Drug: Bisacodyl
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Other: Placebo
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Primary Outcome(s)
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Number of Participants With 30% Improvement From Baseline in Bowel Symptoms at 4 Weeks
[Time Frame: Baseline, 4 weeks]
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Secondary Outcome(s)
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Change From Baseline in PAC-QOL Scores at 4 Weeks
[Time Frame: Baseline, 4 weeks]
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Change From Baseline In Average Number of Fecal Incontinence Episodes at 4 Weeks
[Time Frame: Baseline, 4 weeks]
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Change From Baseline in Fecal Incontinence Severity Index (FISI) Score at 4 Weeks
[Time Frame: Baseline, 4 Weeks]
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Change From Baseline in Fecal Incontinence Quality of Life (FIQL) Score at 4 Weeks
[Time Frame: Baseline, 4 weeks]
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Change From Baseline in Mean PAC-SYM Subscale Scores at 4 Weeks
[Time Frame: Baseline, 4 weeks]
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Change From Baseline in SF-36 Scores at 4 Weeks
[Time Frame: Baseline, 4 weeks]
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Change From Baseline In Average Number of Daily Bowel Movements at 4 Weeks
[Time Frame: Baseline, 4 weeks]
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Change From Baseline In Percent of Subjects With Normal Average Stool Form at 4 Weeks
[Time Frame: Baseline, 4 weeks]
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Secondary ID(s)
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PRO15100104
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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