Treating Anorectal Dysfunction in MS

NCT02609607 | Terminated Phase 2 Results DMC

• 1 other identifier: PRO15100104
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Constipation; Fecal Incontinence; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Change From Baseline in Mean PAC-SYM Subscale Scores at 4 Weeks

  Baseline, 4 weeks

• Change From Baseline in Fecal Incontinence Severity Index (FISI) Score at 4 Weeks

  Baseline, 4 Weeks

• Change From Baseline in Fecal Incontinence Quality of Life (FIQL) Score at 4 Weeks

  Baseline, 4 weeks

• Change From Baseline in PAC-QOL Scores at 4 Weeks

  Baseline, 4 weeks

• Change From Baseline in SF-36 Scores at 4 Weeks

  Baseline, 4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Every other day placement of a placebo rectal suppository for 4 weeks

Other: Placebo

Bisacodyl

EXPERIMENTAL

Every other day placement of a bisacodyl 10 mg rectal suppository for 4 weeks

Drug: Bisacodyl

Interventions

Bisacodyl DRUG

Rectal suppository

Also known as: Dulcolax

Bisacodyl

Placebo OTHER

Rectal suppository

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• David Levinthal: lead
• Consortium of Multiple Sclerosis Centers: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Constipation; Fecal Incontinence; Multiple Sclerosis

Interventions

Bisacodyl

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Early Termination due to Difficulty in Recruitment, leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. David Levinthal
• Organization: University of Pittsburgh Medical Center

levinthald@upmc.edu

14123030525

Study Officials

• David J Levinthal, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 20, 2015
• Study Start: June 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 22, 2020
• Results First Posted: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)