Short Bowel SyndromePhase 3NCT02246816
A Open Label Extension Study for Subjects That Complete Study MP-101-CL-001
A Phase 3 study testing 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized) in people with Short Bowel Syndrome and Short Gut Syndrome, run by Marathon Pharmaceuticals, LLC at 5 sites in United States.
Trial summary
MP-101 will be evaluated in this study to see if it is safe and tolerable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short Bowel Syndrome, Short Gut Syndrome, SBS
- What is being tested?
- 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2015to Feb 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Indiana University
Indianapolis, Indiana, 46202
Regional Infectious Disease Infusion Center
Lima, Ohio, 45801
Vanderbilt Center for Human Nutrition
Nashville, Tennessee, 37212-1150
About this study
Official title: 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.
- Conditions
- Short Bowel Syndrome, Short Gut Syndrome, SBS, Short Gut
- Being tested
- 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)
- 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
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| All Subjects | Experimental | Assigned to receive open-label 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized) Receives: Drug: 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Measured: Up to 120 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startFeb 2015
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Why it stopped: Transfer of IND to different marketing authorization representative.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marathon Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246816
- Sponsor's protocol ID
- MP-101-CL-002OLE
- Status last verified
- Nov 2014
- First submitted
- 19 Sep 2014
- Last updated
- 18 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open Label Extension Study for Subjects That Complete Study MP-101-CL-001
- ClinicalTrials.gov ID
- NCT02246816
- Acronym / sponsor ID
- MP-101-CL-002OLE
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Transfer of IND to different marketing authorization representative.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Marathon Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 23 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MP-101 will be evaluated in this study to see if it is safe and tolerable.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Subjects | Experimental | Drug: 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)Assigned to receive open-label 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | All Subjects |
Primary outcome
Number of Participants with Adverse Events
Time frame: Up to 120 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
Related trials for Short Bowel Syndrome
Active, not recruitingPhase 3
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
Short Bowel Syndrome
Not yet recruitingPhase 2
Efficacy and Safety of TRA16 Administered Orally in Patients With Enteric Hyperoxaluria (EH).
Enteric Hyperoxaluria
RecruitingPhase 3
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
Short Bowel Syndrome
Active, not recruitingObservational study
Registry for Participants With Short Bowel Syndrome
Short Bowel Syndrome
Active, not recruitingPhase 3
A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome
Short Bowel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized) in people with Short Bowel Syndrome and Short Gut Syndrome, run by Marathon Pharmaceuticals, LLC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: Up to 120 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2015.