NCT02246816
Withdrawn
Phase 3
A Phase 3, Open Label Extension Study for Subjects That Complete Study MP-101-CL-001
Overview
- Phase
- Phase 3
- Status
- Withdrawn
- Locations
- 5
- Primary Endpoint
- Number of Participants with Adverse Events
Overview
Brief Summary
MP-101 will be evaluated in this study to see if it is safe and tolerable.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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-
- •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
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
Arms & Interventions
All Subjects
Experimental
Assigned to receive open-label 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)
Intervention: 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized) (Drug)
Outcomes
Primary Outcomes
Number of Participants with Adverse Events
Time Frame: Up to 120 Days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (5)
Loading locations...
Similar Trials
Withdrawn
Phase 3
A Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Investigational Product MP-101 in Subjects With Short Bowel Syndrome Who Have Had an Inadequate Response to Anti-DiarrhealsShort Bowel SyndromeShort Gut SyndromeSBSShort BowelShort GutNCT02242656Marathon Pharmaceuticals, LLC
Completed
Phase 3
Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE)Hereditary Angioedema (HAE)NCT02865720Shire8
Unknown
Phase 3
Open-Label Extension of the Phase III Study With Tramiprosate (3APS) in Patients With Mild to Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT00314912Bellus Health Inc. - a GSK company650
Recruiting
Phase 1
TR128 in Patients With Advanced Solid TumorsAdvanced Solid TumorNCT05751356Tarapeutics Science Inc.50
Recruiting
Phase 3
A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary DiseaseNCT05878769Hoffmann-La Roche2,000