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

Phase 3

Withdrawn

• Conditions: Short Gut Syndrome; Short Bowel Syndrome; SBS; Short Gut
• Interventions: Drug: 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)

• Registration Number: NCT02246816
• Lead Sponsor: Marathon Pharmaceuticals, LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-19
• Study First Submitted QC: 2014-09-22
• Study First Posted: 2014-09-23
• Status Verified: 2014-11
• Study Start: 2015-02
• Last Update Submitted: 2015-02-16
• Last Update Posted: 2015-02-18
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Subjects	0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)	Assigned to receive open-label 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	Up to 120 Days

Trial Locations

Locations (5)

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Regional Infectious Disease Infusion Center; 🇺🇸 Lima, Ohio, United States

Vanderbilt Center for Human Nutrition; 🇺🇸 Nashville, Tennessee, United States