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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Idiopathic Constipation

In brief

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).

Key facts

Study ID

NCT03097861

Run by

Sucampo Pharma Americas, LLC

People needed

552

Starts

2017-03-13

Expected to finish

2017-08-17

Last updated by the study team

2020-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Investigative Site — Foley, Alabama, United States
• Investigative Site — Little Rock, Arkansas, United States
• Investigative Site — Anaheim, California, United States
• Investigative Sitee — Chula Vista, California, United States
• Investigative Site — Garden Grove, California, United States
• Investigative Site — Long Beach, California, United States
• Investigative Site — Los Angeles, California, United States
• Investigative Site — Panorama City, California, United States
• Investigative Site — San Diego, California, United States
• Investigative Site — San Marcos, California, United States
• Investigative Site — Upland, California, United States
• Investigative Site — Colorado Springs, Colorado, United States
• Investigative Site — New London, Connecticut, United States
• Investigative Site — Clearwater, Florida, United States
• Investigative Site — Coral Springs, Florida, United States
• Investigative Site — DeLand, Florida, United States
• Investigative Site — Hialeah, Florida, United States
• Investigative Site — Jupiter, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site 2 — Miami, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site — Miami, Florida, United States
• Investigative Site — Orlando, Florida, United States
• Investigative Site — Plantation, Florida, United States
• Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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