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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03097861

Public ClinicalTrials.gov record NCT03097861. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 2:37 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo, in Adult Subjects With Chronic Idiopathic Constipation

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT03097861
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sucampo Pharma Americas, LLC
Industry
Enrollment
552 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 13, 2017 (Actual)
Primary completion
Aug 17, 2017 (Actual)
Completion
Aug 17, 2017 (Actual)
Last update posted
Jan 14, 2020

2017

United States locations

U.S. sites
67
U.S. states
24
U.S. cities
61
Facility City State ZIP Site status
Investigative Site Birmingham Alabama 35216 —
Investigative Site Foley Alabama 36535 —
Investigative Site Little Rock Arkansas 72212 —
Investigative Site Anaheim California 92805 —
Investigative Sitee Chula Vista California 91910 —
Investigative Site Garden Grove California 92840 —
Investigative Site Long Beach California 90806 —
Investigative Site Los Angeles California 90057 —
Investigative Site Panorama City California 91402 —
Investigative Site San Diego California 92103 —
Investigative Site San Marcos California 92078 —
Investigative Site Upland California 91786 —
Investigative Site Colorado Springs Colorado 80909 —
Investigative Site New London Connecticut 06320 —
Investigative Site Clearwater Florida 33765 —
Investigative Site Coral Springs Florida 33065 —
Investigative Site DeLand Florida 32720 —
Investigative Site Hialeah Florida 33012 —
Investigative Site Jupiter Florida 33458 —
Investigative Site Miami Florida 33142 —
Investigative Site 2 Miami Florida 33143 —
Investigative Site Miami Florida 33143 —
Investigative Site Miami Florida 33165 —
Investigative Site Orlando Florida 32806 —
Investigative Site Plantation Florida 33322 —
Investigative Sitee Port Orange Florida 32129 —
Investigative Site Port Saint Lucie Florida 34952 —
Investigative Site Tampa Florida 33609 —
Investigative Site Tampa Florida 33634 —
Investigative Site West Palm Beach Florida 33409 —
Investigative Site Athens Georgia 30607 —
Investigative Site Snellville Georgia 30078 —
Investigative Site Stockbridge Georgia 30281 —
Investigative Site Blackfoot Idaho 83221 —
Investigative Site Boise Idaho 83712 —
Investigative Site Meridian Idaho 83642 —
Investigative Site Lake Charles Louisiana 70601 —
Investigative Site New Orleans Louisiana 70124 —
Investigative Site Shreveport Louisiana 71101 —
Investigative Site Chevy Chase Maryland 20815 —
Investigative Site Hagerstown Maryland 21742 —
Investigative Site New Bedford Massachusetts 02740 —
Investigative Site Jackson Missouri 39202 —
Investigative Sitee Bellevue Nebraska 68005 —
Investigative Site Las Vegas Nevada 89119 —
Investigative Site The Bronx New York 10459 —
Investigative Sitee High Point North Carolina 27262 —
Investigative Site Raleigh North Carolina 27612 —
Investigative Site Cleveland Ohio 44122 —
Investigative Site Mentor Ohio 44060 —
Investigative Site Midwest City Oklahoma 73110 —
Investigative Site Philadelphia Pennsylvania 19152 —
Investigative Site Charleston South Carolina 29406 —
Investigative Site Spartanburg South Carolina 29303 —
Investigative Site Chattanooga Tennessee 37421 —
Investigative Site 2 Jackson Tennessee 38305 —
Investigative Site Jackson Tennessee 38305 —
Investigative Site Houston Texas 77058 —
Investigative Site Houston Texas 77099 —
Investigative Site Longview Texas 75605 —
Investigative Site McAllen Texas 78504 —
Investigative Site Sugar Land Texas 77479 —
Investigative Site Layton Utah 84041 —
Investigative Site Taylorsville Utah 84123 —
Investigative Site West Jordan Utah 84088 —
Investigative Site Newport News Virginia 23606 —
Investigative Site Richmond Virginia 23220 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03097861, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 14, 2020 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03097861 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →