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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
552

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sucampo Pharma Americas, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 17, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 17, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings