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

February 16, 2015 updated by: Marathon Pharmaceuticals, LLC

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Lima, Ohio, United States, 45801
        • Regional Infectious Disease Infusion Center
    • Tennessee
      • Nashville, Tennessee, United States, 37212-1150
        • Vanderbilt Center for Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All Subjects
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)
0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events
Time Frame: Up to 120 Days
Up to 120 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marathon Pharmaceuticals, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

September 19, 2014

First Submitted That Met QC Criteria

September 22, 2014

First Posted (Estimate)

September 23, 2014

Study Record Updates

Last Update Posted (Estimate)

February 18, 2015

Last Update Submitted That Met QC Criteria

February 16, 2015

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-101-CL-002OLE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Short Bowel Syndrome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe