Trial Outcomes & Findings for Lubiprostone in Patients With Multiple Sclerosis Associated Constipation (NCT NCT01236534)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

21 participants

Primary outcome timeframe

21 days

Results posted on

2015-12-10

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Lubiprostone Lubiprostone : 24 mcg twice daily for 21 days.	Sugar Pill Placebo : matching placebo twice daily for 21 days.
Overall Study STARTED	11	10
Overall Study COMPLETED	8	10
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Lubiprostone Lubiprostone : 24 mcg twice daily for 21 days.	Sugar Pill Placebo : matching placebo twice daily for 21 days.
Overall Study Adverse Event	3	0

Baseline Characteristics

Lubiprostone in Patients With Multiple Sclerosis Associated Constipation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lubiprostone n=11 Participants Lubiprostone : 24 mcg twice daily for 21 days.	Sugar Pill n=10 Participants Placebo : matching placebo twice daily for 21 days.	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	47.6 years STANDARD_DEVIATION 14.8 • n=5 Participants	41.6 years STANDARD_DEVIATION 8.8 • n=7 Participants	44.7 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	10 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 21 days

Population: per protocol

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.

Outcome measures

Outcome measures
Measure	Lubiprostone n=11 Participants Lubiprostone : 24 mcg twice daily for 21 days.	Sugar Pill n=10 Participants Placebo : matching placebo twice daily for 21 days.
Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day.	3.4 spontaneous bowel movements Standard Deviation 0.7	3.2 spontaneous bowel movements Standard Deviation 0.6

SECONDARY outcome

Timeframe: 21 days

Population: per protocol

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.

Outcome measures

Outcome measures
Measure	Lubiprostone n=11 Participants Lubiprostone : 24 mcg twice daily for 21 days.	Sugar Pill n=10 Participants Placebo : matching placebo twice daily for 21 days.
Number of Participants With Diarrheic Events.	8 participants	2 participants

Adverse Events

Lubiprostone

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lubiprostone n=11 participants at risk Lubiprostone : 24 mcg twice daily for 21 days.	Sugar Pill n=10 participants at risk Placebo : matching placebo twice daily for 21 days.
Gastrointestinal disorders diarrhea	72.7% 8/11 • Number of events 8	20.0% 2/10 • Number of events 2

Additional Information

Andrew Goodman, MD

University of Rochester

Phone: 585-275-7854

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60