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



Status:Not yet recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:2/8/2015
Start Date:February 2015
End Date:February 2018
Contact:Cherie Young
Email:cherie.young@ppdi.com
Phone:512-656-2789

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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.


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
We found this trial at
5
sites
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Chicago, IL
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Lima, OH
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Nashville, Tennessee 37212
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Nashville, TN
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