Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sucampo Pharma Americas, LLC
With
Takeda
Sucampo AG
To assess the efficacy and safety of oral lubiprostone, as compared to matching placebo, when administered orally (at 8 mcg twice daily \[BID\]) in subjects diagnosed with IBS-M/IBS-U.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject meets the diagnosis of IBS-M or IBS-U as confirmed using the adapted ROME III Diagnostic Questionnaire for Adult Functional GI Disorders.
Subject Screening diary entries must show an average worst abdominal pain in the past 24 hours score of at least 4 on a 11-point scale.
Subject must be on a stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors if taking antidepressants.
You may not be if
Subject has current diagnosis of IBS with diarrhea (IBS-D) or IBS with constipation (IBS-C), according to Rome III Criteria.
Any gastrointestinal (GI) condition, other than IBS-related, affecting GI motility or defecation.
Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.
Clareo Health | Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome
