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

NCT02246816 | Withdrawn Phase 3

• 1 other identifier: MP-101-CL-002OLE
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Short Bowel Syndrome; Short Gut Syndrome; SBS; Short Gut

Keywords

Short Bowel Syndrome; SBS; Chronic Diarrhea; Short Bowel; Short Gut; Short Gut Syndrome; Anti-Diarrheal; Opium Tincture; loperamide; diphenoxylate; ileostomies; tincture of opium; DTO; codeine; morphine; opiate

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events

  Up to 120 Days

Study Arms (1)

All Subjects

EXPERIMENTAL

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)

Interventions

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)

All Subjects

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marathon Pharmaceuticals, LLC: lead

Study Sites (5)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Regional Infectious Disease Infusion Center

Lima, Ohio, 45801, United States

Location

Vanderbilt Center for Human Nutrition

Nashville, Tennessee, 37212-1150, United States

Location

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: September 23, 2014
• Study Start: February 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 18, 2015

Record last verified: 2014-11

Locations

US (5)