MP-101 will be evaluated in this study to see if it is safe, tolerable, and can help people with Short Bowel Syndrome. This study will also find out if taking MP-101 can improve the symptoms of Short Bowel Syndrome and reduce the number of times subjects experience bowel movements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Treatment A - 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized) QID oral drops, followed by Treatment B - 0.6 mL, MP-101, 1/12 dilution, (0.833 mg/mL, OT), USP (Deodorized) QID oral drops, followed by Treatment C - 0.6 mL, MP-101 (10 mg/mL Opium Tincture with reduced uncharacterized material) QID oral drops
Treatment B - 0.6 mL, MP-101, 1/12 dilution, (0.833 mg/mL, OT), USP (Deodorized) QID oral drops, followed by Treatment A - 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized) QID oral drops, followed by Treatment C - 0.6 mL, MP-101 (10 mg/mL Opium Tincture with reduced uncharacterized material) QID oral drops
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Cleveland Clinic
Cleveland, Ohio, United States
Regional Infectious Diseases Infusion Center
Lima, Ohio, United States
Percentage of responders between Treatments A and B for the Intent-To-Treat (ITT) population
30% or greater reduction in 24-hour stool volume from baseline
Time frame: Last day of Periods 1 (Days 16-17) and 2 (Days 25-26)
Percentage of responders between Treatments A and B for the Modified-Intent-To-Treat (mITT) population
30% or greater reduction in 24-hour stool volume from baseline for subjects who complete both periods 1 and 2 of the randomized, blinded, crossover portion of the study
Time frame: Last day of Periods 1 (Days 16-17) and 2 (Days 25-26)
Establish non-inferiority of the percentage of responders between Treatment A and Treatment C
30% or greater reduction in stool volume from baseline between Treatment A (with uncharacterized material) and Treatment C (with reduced uncharacterized material) for ITT and mITT efficacy population (subjects from the ITT population who complete both Treatments A and C)
Time frame: Last day of Period 3 (Day 34-35)
24-hour stool volume comparison between Treatment A and B for ITT and mITT
Comparison of stool volume measurements
Time frame: Last day of Periods 1 (Day 16-17) and 2 (Day 25-26)
24-hour fecal events between Treatment A and B for ITT and mITT
Changes in the number of 24-hour fecal events for ITT and mITT
Time frame: Period 1 (Day 10-16) and 2 (Day 19-25)
24-hour nocturnal fecal events between Treatment A and B for ITT and mITT
Changes in the number of 24-hour nocturnal (ad defined for each subject) fecal events for ITT and mITT
Time frame: Period 1 (Day 10-16) and 2 (Day 19-25)
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Vanderbilt Center for Human Nutrition
Nashville, Tennessee, United States
Single and multiple dose Pharmacokinetic (PK) parameters
Evaluate the pharmacokinetics of morphine, codeine, thebaine and papaverine after single dose and multiple dose administration of MP-101
Time frame: Day-1, Day 1, Day 7, Day 57-59
Number of Participants with Adverse Events
Review of safety events throughout the course of the study
Time frame: Up to 60 Days
Number of Participants Up-Titrated
Review of safety events throughout the course of the study
Time frame: Days 35-60