NCT02242656
Withdrawn
Phase 3
A Phase 3, Open Label Responder Treatment Period With a Randomized, Blinded, Three-Period Crossover, Followed by an Open Label Safety Period to Evaluate the Clinical Efficacy, Safety, and Pharmacokinetics of Investigational Drug MP-101 (Opium Tincture and Opium Tincture With Reduced Uncharacterized Material) to Treat Chronic Diarrhea in Subjects With Short Bowel Syndrome Who Have Had an Inadequate Response to Anti-Diarrheals
InterventionsOpium Tincture USP Deodorized
Overview
- Phase
- Phase 3
- Status
- Withdrawn
- Locations
- 5
- Primary Endpoint
- Percentage of responders between Treatments A and B for the Intent-To-Treat (ITT) population
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Be male or female adults, 18 years of age or older at the time of consent
- •Have SBS that is inadequately controlled on current antidiarrheal medication (e.g., loperamide or diphenoxylate), including subjects with ileostomies, based on the 7 days prior to Day 1 of the study
- •a. Subjects must be \>3months post intestinal resection
- •Have a history of persistent loose stools for more than 4 weeks
- •Be on a combination of Opium Tincture and an anti-diarrheal (loperamide or diphenoxylate) or an anti-diarrheal agent alone
- •If currently taking Opium Tincture, be willing to stop the continued use of Opium Tincture at screening visit until the start of study treatment and willing to stop the use of any other anti-diarrheal for the duration of the study
- •Be able to maintain their current diet for the duration of the study
- •Be on stable nutritional support (parenteral or oral)
- •Males or non-pregnant, non-lactating females who are postmenopausal, naturally or surgically sterile, or who agree to use effective contraceptive methods throughout the course of the study. Postmenopausal is defined as at least 12 months of natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause (bilateral oophorectomy)
- •Females of childbearing potential must agree to use 1 of the following acceptable birth control methods:
Exclusion Criteria
- •Unable or unwilling to stop the use of Opium Tincture or any anti-diarrheal medication at the screening visit.
- •Have any history of or active neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, or metabolic disease that is considered clinically significant, is not currently controlled by medication, and is stable as deemed by the Investigator
- •Have clinically significant electrocardiogram (ECG) abnormalities as determined by the PI or vital sign abnormalities (systolic blood pressure \< 90 mmHg, diastolic blood pressure \< 60 mmHg, or heart rate \>100 bpm) at screening
- •Have clinically significant elevation of liver enzymes (\> 3 times the upper limit of normal) or clinically relevant renal disease, (creatinine \>1.5) or any other clinically significant abnormal laboratory test results found during medical screening as determined by the Principal Investigator
- •Have a history of major mental illness that in the opinion of the Investigator may affect the ability of the subject to safely participate and reliably complete the study
- •Have a history of alcohol or substance abuse within the past 2 years. Alcohol abuse will be defined as \>14 drinks per week (1 drink = 12 oz. beer, 5.0 oz. wine, or 1.5 oz. distilled spirits)
- •Have a known allergy or intolerance to Opium Tincture or any of the excipients in the formulation (alcohol, opium, or morphine)
- •Is currently taking an opioid derivative (other than Opium Tincture) or any other medication which, in the opinion of the investigator, could interfere with the interpretation of the study results
- •Are currently taking antibiotics for bacterial overgrowth
- •Have participated in another interventional clinical trial within 30 days prior to screening with the exception of observational cohort studies or non-interventional studies.
Arms & Interventions
Group 1
Experimental
Assigned to receive Treatment A (Period 1), Treatment B (Period 2), Treatment C (Period 3)
Intervention: Opium Tincture USP Deodorized (Drug)
Group 2
Experimental
Assigned to receive Treatment B (Period 1), Treatment A (Period 2), Treatment C (Period 3)
Intervention: Opium Tincture USP Deodorized (Drug)
Outcomes
Primary Outcomes
Percentage of responders between Treatments A and B for the Intent-To-Treat (ITT) population
Time Frame: Last day of Periods 1 (Days 16-17) and 2 (Days 25-26)
30% or greater reduction in 24-hour stool volume from baseline
Secondary Outcomes
- Establish non-inferiority of the percentage of responders between Treatment A and Treatment C(Last day of Period 3 (Day 34-35))
- 24-hour fecal events between Treatment A and B for ITT and mITT(Period 1 (Day 10-16) and 2 (Day 19-25))
- Number of Participants with Adverse Events(Up to 60 Days)
- 24-hour nocturnal fecal events between Treatment A and B for ITT and mITT(Period 1 (Day 10-16) and 2 (Day 19-25))
- Percentage of responders between Treatments A and B for the Modified-Intent-To-Treat (mITT) population(Last day of Periods 1 (Days 16-17) and 2 (Days 25-26))
- 24-hour stool volume comparison between Treatment A and B for ITT and mITT(Last day of Periods 1 (Day 16-17) and 2 (Day 25-26))
- Single and multiple dose Pharmacokinetic (PK) parameters(Day-1, Day 1, Day 7, Day 57-59)
- Number of Participants Up-Titrated(Days 35-60)
Investigators
Study Sites (5)
Loading locations...
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