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

Short Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02246816
• Other study ID #: MP-101-CL-002OLE
• Status: Withdrawn
• Phase: Phase 3
• First received: September 19, 2014
• Last updated: February 16, 2015
• Start date: February 2015
• Est. completion date: February 2018

Study information

• Verified date: November 2014
• Source: Marathon Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• SBS
• Short Bowel Syndrome
• Short Gut
• Short Gut Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Indiana University	Indianapolis	Indiana
United States	Regional Infectious Disease Infusion Center	Lima	Ohio
United States	Vanderbilt Center for Human Nutrition	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Marathon Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events		Up to 120 Days	Yes