Multiple SclerosisPhase 4NCT01236534
Lubiprostone in Patients With Multiple Sclerosis Associated Constipation
A Phase 4 study testing Lubiprostone in people with Multiple Sclerosis and Constipation, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of the study is to assess how safe and effective the drug Lubiprostone is in people with Multiple Sclerosis (MS)and moderate to severe MS-associated constipation. Lubiprostone is approved by the FDA for the treatment of two common types of constipation in adults, chronic idiopathic constipation and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Constipation
- What is being tested?
- Lubiprostone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Apr 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Multiple Sclerosis
- Chronic Constipation defined as < 3 spontaneous bowel movements per week by history and confirmed by diary during the 14 day washout period.
- Women of child-bearing potential must agree to use adequate birth control.
Who cannot join
- history of other clinically significant medical or psychiatric disorders or suicidal ideation.
- Subjects who have a suspicion of a mechanical bowel obstruction by clinical evaluation prior to dosing that include nausea, vomiting, abdominal pain or distention.
- Subjects with a positive urine pregnancy test prior to dosing.
- Medication changes within one month prior to visit one.
- Corticosteroid use within 2 months prior to visit one.
- Age<18.
- Known intolerance to lubiprostone.
- Inability to perform any required study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-groups Study of Lubiprostone in Patients With Multiple Sclerosis-Associated Constipation
The purpose of the study is to assess how safe and effective the drug Lubiprostone is in people with Multiple Sclerosis (MS)and moderate to severe MS-associated constipation. Lubiprostone is approved by the FDA for the treatment of two common types of constipation in adults, chronic idiopathic constipation and irritable bowel syndrome.
Read the detailed description
Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system. Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the bowel. In people with MS, the covering around the nerve fibers deteriorates, causing nerve impulses to be slowed or stopped. as a result, patients with MS may experiences constipation.
- Conditions
- Multiple Sclerosis, Constipation
- Being tested
- Lubiprostone, Placebo
- Keywords
- Multiple Sclerosis, Constipation, Multiple Sclerosis Associated Constipation
- Medical subject headings
- Multiple Sclerosis, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LubiprostoneDrug
Also called Amitiza
24 mcg twice daily for 21 days.
PlaceboDrug
Also called Sugar pill
matching placebo twice daily for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Lubiprostone | Active comparator | Not described Receives: Drug: Lubiprostone |
| Sugar pill | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day.
Number of of lubiprostone 24 mcg twice daily on spontaneous bowel movements (SBM) in patients with multiple sclerosis (MS)-associated constipation per day. Hypothesis: Lubiprostone-treated patients will have more SBM's than placebo-treated patients.
Measured: 21 days
Secondary outcomes (1)
Number of Participants With Diarrheic Events.
To determine the safety of lubiprostone based on adverse event (AE) type, frequency, and severity. Hypothesis: AE type, frequency, and severity will be comparable in lubiprostone and placebo treated patients.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Principal investigator, Andrew Goodman, University of Rochester
- Investigators
- Andrew D Goodman, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236534
- Sponsor's protocol ID
- URMC08-022LUB
- Status last verified
- Nov 2015
- First submitted
- 4 Nov 2010
- Last updated
- 10 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-groups Study of Lubiprostone in Patients With Multiple Sclerosis-Associated Constipation
- ClinicalTrials.gov ID
- NCT01236534
- Acronym / sponsor ID
- URMC08-022LUB
- Conditions
- Multiple Sclerosis, Constipation
- Keywords
- Multiple Sclerosis, Constipation, Multiple Sclerosis Associated Constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- Nov 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 8 Nov 2010 (estimated)
- Results
- Posted 10 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess how safe and effective the drug Lubiprostone is in people with Multiple Sclerosis (MS)and moderate to severe MS-associated constipation. Lubiprostone is approved by the FDA for the treatment of two common types of constipation in adults, chronic idiopathic constipation and irritable bowel syndrome.
Detailed description
Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system. Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the bowel. In people with MS, the covering around the nerve fibers deteriorates, causing nerve impulses to be slowed or stopped. as a result, patients with MS may experiences constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lubiprostone | Active comparator | Drug: Lubiprostone |
| Sugar pill | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Multiple Sclerosis
- Chronic Constipation defined as < 3 spontaneous bowel movements per week by history and confirmed by diary during the 14 day washout period.
- Women of child-bearing potential must agree to use adequate birth control.
Key exclusion criteria (8 listed)
- history of other clinically significant medical or psychiatric disorders or suicidal ideation.
- Subjects who have a suspicion of a mechanical bowel obstruction by clinical evaluation prior to dosing that include nausea, vomiting, abdominal pain or distention.
- Subjects with a positive urine pregnancy test prior to dosing.
- Medication changes within one month prior to visit one.
- Corticosteroid use within 2 months prior to visit one.
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 |
|---|---|---|
| LubiprostoneAlso: Amitiza24 mcg twice daily for 21 days. | Drug | Lubiprostone |
| PlaceboAlso: Sugar pillmatching placebo twice daily for 21 days. | Drug | Sugar pill |
Primary outcome
Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day.
Time frame: 21 days
Number of of lubiprostone 24 mcg twice daily on spontaneous bowel movements (SBM) in patients with multiple sclerosis (MS)-associated constipation per day. Hypothesis: Lubiprostone-treated patients will have more SBM's than placebo-treated patients.
1 secondary outcome
Number of Participants With Diarrheic Events.
Time frame: 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Andrew D Goodman, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lubiprostone in people with Multiple Sclerosis and Constipation, run by University of Rochester at 1 site 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day. (time frame: 21 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 10 Dec 2015.