Clinical trial NCT02246816: A Open Label Extension Study for Subjects That Complete Study MP-101-CL-001
Official title: A Phase 3, Open Label Extension Study for Subjects That Complete Study MP-101-CL-001
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
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
Lead sponsor: Marathon Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2014-09-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Up to 120 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Lima
country: United States
facility: Regional Infectious Disease Infusion Center
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt Center for Human Nutrition
state: Tennessee
Study officials:
References: