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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lubiprostone | Active Comparator |
| |
| Sugar pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lubiprostone | Drug | 24 mcg twice daily for 21 days. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew D Goodman, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
After inclusion criteria and screening, subjects were instructed to D/C all over the counter and Rx bowel medications except for fiber supplements for 14 days. Any subject with >2 BM/Week were excluded. 40 patients screened and 21 randomization, 18 were ineligible D/T a high baseline SBM count, and 1 was unable to reschedule.
Recruitment occured in the Multiple Sclerosis Clinic at the University of Rochester, which began on 08/30/2010 until the last subject was enrolled on 12/27/2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lubiprostone | Lubiprostone : 24 mcg twice daily for 21 days. |
| FG001 | Sugar Pill | Placebo : matching placebo twice daily for 21 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lubiprostone | Lubiprostone : 24 mcg twice daily for 21 days. |
| BG001 | Sugar Pill | Placebo : matching placebo twice daily for 21 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | per protocol | Posted | Mean | Standard Deviation | spontaneous bowel movements | 21 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lubiprostone | Lubiprostone : 24 mcg twice daily for 21 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Goodman, MD | University of Rochester | 585-275-7854 | andrew_goodman@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000068238 | Lubiprostone |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D000527 | Alprostadil |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
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| Placebo | Drug | matching placebo twice daily for 21 days. |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | per protocol | Posted | Number | participants | 21 days |
|
|
|
| 0 |
| 11 |
| 8 |
| 11 |
| EG001 | Sugar Pill | Placebo : matching placebo twice daily for 21 days. | 0 | 10 | 2 | 10 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008055 |
| Lipids |
| D002241 | Carbohydrates |