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

January 10, 2020 updated by: Sucampo Pharma Americas, LLC

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

552

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lubiprostone Capsule
Lubiprostone 24 mcg capsule twice daily (BID) for 7 days.
Drug: Lubiprostone
24 mcg administered orally BID
Other Names:
  • Amitiza
Experimental: Lubiprostone Sprinkle
Lubiprostone 24 mcg sprinkle BID for 7 days.
Drug: Lubiprostone
24 mcg administered orally BID
Other Names:
  • Amitiza
Placebo Comparator: Placebo
Placebo matching to lubiprostone (sprinkle/capsule) BID for 7 days.
Drug: Placebo
24 mcg administered orally BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week
Time Frame: during the 1-week treatment period
Observed SBM count was based on the observed data reported in the electronic daily diary for the actual number of SBMs during the 1-week treatment period.
during the 1-week treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean SBM Consistency Score Within 1 Week
Time Frame: during the 1-week treatment period
Stool consistency associated with SBMs was rated according to the 7-point Bristol Stool Form Scale (1-7) where 1 = Separate hard lumps, like nuts (hard to pass), 2 = Sausage-shaped but lumpy, 3 = Like a sausage but with cracks on the surface, 4 = Like a sausage or snake, smooth and soft, 5 = Soft blobs with clear-cut edges (passed easily), 6 = Fluffy pieces with ragged edges, a mushy stool, 7 = Watery, no solid pieces; entirely liquid. Scores in the mid-range of this scale indicate better stool consistency.
during the 1-week treatment period
Mean SBM Straining Score Within 1 Week
Time Frame: during the 1-week treatment period
Bowel straining associated with SBMs was rated on a scale of 0-4 where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very severe. Higher score indicates more straining, so a worse condition.
during the 1-week treatment period
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: From first dose of study medication to follow-up (up to 15 days)
An adverse event (AE) is any untoward medical occurrence (including clinically significant changes in laboratory values or other clinical tests) experienced by a participant administered a pharmaceutical product regardless of causal relationship with the treatment. A TEAE is an episode which occur after the administration of the first dose of study medication and within 7 days after final dose.
From first dose of study medication to follow-up (up to 15 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sucampo Pharma Americas, LLC

Collaborators

Sucampo AG
Sucampo Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2017

Primary Completion (Actual)

August 17, 2017

Study Completion (Actual)

August 17, 2017

Study Registration Dates

First Submitted

March 27, 2017

First Submitted That Met QC Criteria

March 30, 2017

First Posted (Actual)

March 31, 2017

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCMP-0211-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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