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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02246816
Recruitment Status : Withdrawn (Transfer of IND to different marketing authorization representative.)
First Posted : September 23, 2014
Last Update Posted : February 18, 2015
Sponsor:
Information provided by (Responsible Party):
Marathon Pharmaceuticals, LLC

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

Condition or disease Intervention/treatment Phase
Short Bowel Syndrome Short Gut Syndrome SBS Short Gut Drug: 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open Label Extension Study for Subjects That Complete Study MP-101-CL-001
Study Start Date : February 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Opium

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)




Primary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: Up to 120 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246816


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

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Responsible Party: Marathon Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT02246816     History of Changes
Other Study ID Numbers: MP-101-CL-002OLE
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: November 2014
Keywords provided by Marathon Pharmaceuticals, LLC:
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
Additional relevant MeSH terms:
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Short Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Opium
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidiarrheals
Gastrointestinal Agents
Antitussive Agents
Respiratory System Agents