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WithdrawnNCT02246816Updated Feb 18, 2015

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

A Phase 3 interventional study of 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized) in Short Bowel Syndrome, Short Gut Syndrome and SBS, sponsored by Marathon Pharmaceuticals, LLC. Withdrawn at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-18.

Sponsored by Marathon Pharmaceuticals, LLC · Phase 3, Interventional, and Treatment

Why this study was withdrawn
Transfer of IND to different marketing authorization representative.
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • 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
03

In context

Short Bowel Syndrome

149 studies on the registry are indexed under Short Bowel Syndrome; 25 are open to participants now.

Browse Short Bowel Syndrome studies →

Lead sponsor

Marathon Pharmaceuticals, LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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)

Interventions

  • Drug0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)

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

06

What researchers measure

Primary outcomes

  1. Number of Participants with Adverse Events

    Time frame: Up to 120 Days

07

Study locations

5 sites
  • Northwestern University Feinberg School of Medicine
    Chicago, Illinois 60611, United States
  • Indiana University
    Indianapolis, Indiana 46202, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • Regional Infectious Disease Infusion Center
    Lima, Ohio 45801, United States
  • Vanderbilt Center for Human Nutrition
    Nashville, Tennessee 37212-1150, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02246816
Lead sponsor
Marathon Pharmaceuticals, LLC
Responsible party
Sponsor
First posted
Sep 23, 2014
Start date
Feb 2015
Primary completion
Feb 2018 (estimated)
Completion
Feb 2018 (estimated)
Last update
Feb 18, 2015
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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