Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT01236534
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01236534
Study Brief:
Protocol Section:
NCT01236534