Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo

• Status: Completed
• Trial end date: 2017-08-17
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo, when administered orally in participants with Chronic Idiopathic Constipation (CIC).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sucampo AG; Sucampo Pharma Americas, LLC
• Collaborators: Sucampo AG; Sucampo Pharmaceuticals, Inc.; Takeda
• Treatments: Lubiprostone

Criteria

Inclusion Criteria:

• Either has medically-confirmed diagnosis of chronic constipation (per Rome III), or meets the diagnosis as confirmed using the Rome III constipation module questionnaire during the Screening period.

• Is male or female, 18 or older years of age

• Should be on stable dose of fiber supplement or a concomitant medication for the indication of lowering blood pressure

Exclusion Criteria:

• Has any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation

• Is unable to eat or drink, take oral medications, or to hold down oral medications due to vomiting