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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

Tracking Information
First Submitted Date  ICMJE November 4, 2010
First Posted Date  ICMJE November 8, 2010
Results First Submitted Date  ICMJE January 31, 2013
Results First Posted Date  ICMJE December 10, 2015
Last Update Posted Date December 10, 2015
Study Start Date  ICMJE November 2010
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2010)
To determine the effect of lubiprostone 24 mcg twice daily on spontaneous bowel movements in patients with MS-associated constipation [ Time Frame: 21 days ]
Change History Complete list of historical versions of study NCT01236534 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2015)
Number of Participants With Diarrheic Events. [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2010)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lubiprostone in Patients With Multiple Sclerosis Associated Constipation
Official Title  ICMJE Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-groups Study of Lubiprostone in Patients With 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Sclerosis
  • Constipation
Intervention  ICMJE
  • Drug: Lubiprostone
    24 mcg twice daily for 21 days.
    Other Name: Amitiza
  • Drug: Placebo
    matching placebo twice daily for 21 days.
    Other Name: Sugar pill
Study Arms  ICMJE
  • Active Comparator: Lubiprostone
    Intervention: Drug: Lubiprostone
  • Placebo Comparator: Sugar pill
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2015)
21
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2010)
40
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01236534
Other Study ID Numbers  ICMJE URMC08-022LUB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrew Goodman, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE Takeda
Investigators  ICMJE
Principal Investigator: Andrew D Goodman, MD University of Rochester
PRS Account University of Rochester
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP