Expired Study
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Pittsburgh, Pennsylvania 15213


Purpose:

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.


Study summary:

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.


Criteria:

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.


Study is Available At:


Original ID:

PRO15100104


NCT ID:

NCT02609607


Secondary ID:


Study Acronym:


Brief Title:

Treating Anorectal Dysfunction in MS


Official Title:

Treating Anorectal Dysfunction Associated With Multiple Sclerosis


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pittsburgh


Oversight Authority:

United States: Data and Safety Monitoring Board


Reasons Why Stopped:

Poor enrollment; funding ending Dec 31, 2018


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

11


Enrollment Type:

Actual


Overall Contact Information

Official Name:David J Levinthal, MD, PhD
Principal Investigator
University of Pittsburgh

Study Dates

Start Date:June 2016
Completion Date:December 2018
Completion Type:Actual
Primary Completion Date:November 2018
Primary Completion Type:Actual
Verification Date:December 2018
Last Changed Date:December 5, 2018
First Received Date:November 16, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Global Subjective Assessment PRO
Time Frame:4 weeks
Safety Issues:False
Description:"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?"
Outcome Type:Secondary Outcome
Measure:Bowel Function (Bristol Stool Scale)
Time Frame:4 weeks
Safety Issues:False
Description:Daily Bowel Diaries - patients will record the consistency of each stool using the Bristol Stool Scale (numerical coded scale 1-7) during the study period.
Outcome Type:Secondary Outcome
Measure:Bowel Function (daily number of bowel movements)
Time Frame:4 weeks
Safety Issues:False
Description:Daily Bowel Diaries - daily number of bowel movements (BM) will be recorded during the study period.
Outcome Type:Secondary Outcome
Measure:Bowel Function (daily number of fecal incontinence (FI) episodes)
Time Frame:4 weeks
Safety Issues:False
Description:Daily Bowel Diaries - daily number of fecal incontinence (FI) episodes will be recorded during the study period.
Outcome Type:Secondary Outcome
Measure:Constipation Severity (PAC-SYM)
Time Frame:4 weeks
Safety Issues:False
Description:Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM)
Outcome Type:Secondary Outcome
Measure:Fecal Incontinence Severity (FISI)
Time Frame:4 weeks
Safety Issues:False
Description:Fecal Incontinence Severity Index (FISI)
Outcome Type:Secondary Outcome
Measure:Quality of Life (SF-36)
Time Frame:4 weeks
Safety Issues:False
Description:SF-36
Outcome Type:Secondary Outcome
Measure:Constipation-Related Quality of Life (PAC-QOL)
Time Frame:4 weeks
Safety Issues:False
Description:Patient Assessment of Constipation QOL (PAC-QOL)
Outcome Type:Secondary Outcome
Measure:Fecal Incontinence-Related Quality of Life (FIQL)
Time Frame:4 weeks
Safety Issues:False
Description:Rockwood Fecal Incontinence Quality of Life Scale (FIQL)

Study Interventions

Intervention Type:Drug
Name:Bisacodyl
Description:Rectal suppository
Arm Name:Bisacodyl
Other Name:Dulcolax
Intervention Type:Other
Name:Placebo
Description:Rectal suppository
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Every other day placement of a placebo rectal suppository for 4 weeks
Study Arm Type:Experimental
Arm Name:Bisacodyl
Description:Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:David Levinthal
Agency Class:Other
Agency Type:Collaborator
Agency Name:Consortium of Multiple Sclerosis Centers

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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