A Open Label Extension Study for Subjects That Complete Study MP-101-CL-001

Study Overview
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Brief Summary
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MP-101 will be evaluated in this study to see if it is safe and tolerable.

Official Title
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A Phase 3, Open Label Extension Study for Subjects That Complete Study MP-101-CL-001

Conditions
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Short Bowel Syndrome, Short Gut Syndrome, SBS, Short Gut

Intervention / Treatment
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* Drug: 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be male or female adults, 18 years of age or older Have SBS that is inadequately controlled on current antidiarrheal medication (e.g., loperamide or diphenoxylate), including subjects with ileostomies Must have been deemed a completer of study protocol MP-101-CL-001. 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: Surgically sterile (hysterectomy or bilateral oophorectomy) Surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation) Intrauterine device (IUD) in place for at least 3 months Abstinence (not having sexual intercourse) Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening and through study completion Stable hormonal contraceptive for at least 3 months prior to study and through study completion Vasectomized partner Females of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at Visit 1. Be able to understand and provide signed informed consent Exclusion Criteria: 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 Are currently taking antibiotics for bacterial overgrowth Have known or suspected pregnancy, planned pregnancy, or lactation Have a planned surgery during the course of the study Have a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Subjects<br>Assigned to receive open-label 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized) | Drug: 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)<br>* 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events |  | Up to 120 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SBS, Short Bowel Syndrome, Chronic Diarrhea, Short Bowel, Short Gut, Short Gut Syndrome, Anti-Diarrheal, Opium Tincture, loperamide, diphenoxylate, ileostomies, tincture of opium, DTO, codeine, morphine, opiate