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Lubiprostone in Patients With Multiple Sclerosis Associated Constipation

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ClinicalTrials.gov Identifier: NCT01236534
Recruitment Status : Completed
First Posted : November 8, 2010
Results First Posted : December 10, 2015
Last Update Posted : December 10, 2015
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Andrew Goodman, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Multiple Sclerosis
Constipation
Interventions Drug: Lubiprostone
Drug: Placebo
Enrollment 21
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.
Arm/Group Title Lubiprostone Sugar Pill
Hide Arm/Group Description Lubiprostone : 24 mcg twice daily for 21 days. Placebo : matching placebo twice daily for 21 days.
Period Title: Overall Study
Started 11 10
Completed 8 [1] 10
Not Completed 3 0
Reason Not Completed
Adverse Event             3             0
[1]
2 subjects stopped treatment due to diarrhea, and 1 stopped treatment due to constipation.
Arm/Group Title Lubiprostone Sugar Pill Total
Hide Arm/Group Description Lubiprostone : 24 mcg twice daily for 21 days. Placebo : matching placebo twice daily for 21 days. Total of all reporting groups
Overall Number of Baseline Participants 11 10 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
10
 100.0%
21
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 21 participants
47.6  (14.8) 41.6  (8.8) 44.7  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
Female
8
  72.7%
8
  80.0%
16
  76.2%
Male
3
  27.3%
2
  20.0%
5
  23.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 10 participants 21 participants
11 10 21
1.Primary Outcome
Title Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Lubiprostone Sugar Pill
Hide Arm/Group Description:
Lubiprostone : 24 mcg twice daily for 21 days.
Placebo : matching placebo twice daily for 21 days.
Overall Number of Participants Analyzed 11 10
Mean (Standard Deviation)
Unit of Measure: spontaneous bowel movements
3.4  (0.7) 3.2  (0.6)
2.Secondary Outcome
Title Number of Participants With Diarrheic Events.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Lubiprostone Sugar Pill
Hide Arm/Group Description:
Lubiprostone : 24 mcg twice daily for 21 days.
Placebo : matching placebo twice daily for 21 days.
Overall Number of Participants Analyzed 11 10
Measure Type: Number
Unit of Measure: participants
8 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lubiprostone Sugar Pill
Hide Arm/Group Description Lubiprostone : 24 mcg twice daily for 21 days. Placebo : matching placebo twice daily for 21 days.
All-Cause Mortality
Lubiprostone Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lubiprostone Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lubiprostone Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/11 (72.73%)      2/10 (20.00%)    
Gastrointestinal disorders     
diarrhea   8/11 (72.73%)  8 2/10 (20.00%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Andrew Goodman, MD
Organization: University of Rochester
Phone: 585-275-7854
Responsible Party: Andrew Goodman, University of Rochester
ClinicalTrials.gov Identifier: NCT01236534     History of Changes
Other Study ID Numbers: URMC08-022LUB
First Submitted: November 4, 2010
First Posted: November 8, 2010
Results First Submitted: January 31, 2013
Results First Posted: December 10, 2015
Last Update Posted: December 10, 2015