Constipation, Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Constipation, Multiple Sclerosis Associated Constipation
Brief 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 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.
Interventions
DRUGLubiprostone
24 mcg twice daily for 21 days.
DRUGPlacebo
matching placebo twice daily for 21 days.
Sponsors
Takeda
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Diarrheic Events. | 21 days | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Lubiprostone Lubiprostone : 24 mcg twice daily for 21 days. | 11 |
| Sugar Pill Placebo : matching placebo twice daily for 21 days. | 10 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
Baseline characteristics
| Characteristic | Sugar Pill | Lubiprostone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 11 Participants | 21 Participants |
| Age, Continuous | 41.6 years STANDARD_DEVIATION 8.8 | 47.6 years STANDARD_DEVIATION 14.8 | 44.7 years STANDARD_DEVIATION 12.4 |
| Region of Enrollment United States | 10 participants | 11 participants | 21 participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 11 | 2 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 |
Outcome results
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.
Time frame: 21 days
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day. | 3.4 spontaneous bowel movements | Standard Deviation 0.7 |
| Sugar Pill | Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day. | 3.2 spontaneous bowel movements | Standard Deviation 0.6 |
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.
Time frame: 21 days
Population: per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lubiprostone | Number of Participants With Diarrheic Events. | 8 participants |
| Sugar Pill | Number of Participants With Diarrheic Events. | 2 participants |