Evaluation of Clinical Equivalence Between Two Lubiprostone Products

July 10, 2012 updated by: Anchen Pharmaceuticals, Inc

A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of Lubiprostone 24 Mcg Capsules (Anchen Pharmaceuticals, Inc.) With AMITIZA® (Lubiprostone) 24 Mcg Capsules (Sucampo Pharmaceuticals, Inc.) in the Treatment of Chronic Idiopathic Constipation

The objective of this study is to evaluate the clinical equivalence and safety of the Test formulation of lubiprostone 24 mcg capsules compared to the marketed formulation AMITIZA® (lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed chronic idiopathic constipation.

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.
808

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
      • Dothan, Alabama, United States
        • Novum Investigator Site
      • Huntsville, Alabama, United States
        • Novum Investigator Site
      • Mobil, Alabama, United States
        • Novum Investigator Site
    • Arizona
      • Chandler, Arizona, United States
        • Novum Investigator Site
      • Gilbert, Arizona, United States
        • Novum Investigator Site
      • Mesa, Arizona, United States
        • Novum Investigator Site
      • Phoenix, Arizona, United States
        • Novum Investigator Site
      • Phoeniz, Arizona, United States
        • Novum Investigator Site
    • Arkansas
      • Hot Springs, Arkansas, United States
        • Novum Investigator Site
      • Little Rock, Arkansas, United States
        • Novum Investigator Site
      • Mountain Home, Arkansas, United States
        • Novum Investigator Site
      • Sherwood, Arkansas, United States
        • Novum Investigator Site
    • California
      • Buena Park, California, United States
        • Novum Investigator Site
      • Fresno, California, United States
        • Novum Investigator Site
      • Garden Grove, California, United States
        • Novum Investigator Site
      • La Palma, California, United States
        • Novum Investigator Site
      • Long Beach, California, United States
        • Novum Investigator Site
      • Sacremento, California, United States
        • Novum Investigator Site
      • San Diego, California, United States
        • Novum Investigator Site
      • San Ramon, California, United States
        • Novum Invesitgator Site
      • Santa Ana, California, United States
        • Novum Investigator Site
      • Westlake Village, California, United States
        • Novum Investigator Site
    • Colorado
      • Denver, Colorado, United States
        • Novum Investigator Site
      • WheatRidge, Colorado, United States
        • Novum Investigator Site
    • Florida
      • Adventura, Florida, United States
        • Novum Investigator Site
      • Boyton Beach, Florida, United States
        • Novum Investigator Site
      • Bradenton, Florida, United States
        • Novum Investigator Site
      • Brookville, Florida, United States
        • Novum Investigator Site
      • Clearwater, Florida, United States
        • Novum Investigator Site
      • Deerfield Beach, Florida, United States
        • Novum Investigator Site
      • Jupiter, Florida, United States
        • Novum Investigator Site
      • Maimi, Florida, United States
        • Novum Investigator Site
      • Miami, Florida, United States
        • Novum Investigator Site
      • Niceville, Florida, United States
        • Novum Investigator Site
      • Ormond Beach, Florida, United States
        • Novum Investigator Site
      • Panama City, Florida, United States
        • Novum Investigator Site
      • Port Orange, Florida, United States
        • Novum Investigator Site
      • St. Petersburg, Florida, United States
        • Novum Investigator Site
      • Tampa, Florida, United States
        • Novum Investigator Site
      • West Palm Beach, Florida, United States
        • Novum Investigator Site
    • Georgia
      • Decauter, Georgia, United States
        • Novum Investigator Site
      • Sandy Springs, Georgia, United States
        • Novum Investigator Site
      • Stockbridge, Georgia, United States
        • Novum Investigator Site
    • Idaho
      • Lewiston, Idaho, United States
        • Novum Investigator Site
    • Illinois
      • Rockford, Illinois, United States
        • Novum Investigator Site
    • Indiana
      • Evansville, Indiana, United States
        • Novum Investigator Site
    • Kentucky
      • Lexington, Kentucky, United States
        • Novum Investigator Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Novum Investigator Site
    • Maryland
      • Hollywood, Maryland, United States
        • Novum Invesitgator Site
    • Mississippi
      • Jackson, Mississippi, United States
        • Novum Investigator Site
    • Missouri
      • Mexico, Missouri, United States
        • Novum Investigator Site
      • Washington, Missouri, United States
        • Novum Investigator Site
    • Montana
      • Billings, Montana, United States
        • Novum Investigator Site
    • Nebraska
      • Lincoln, Nebraska, United States
        • Novum Investigator Site
    • Nevada
      • Henderson, Nevada, United States
        • Novum Investigator Site
    • New Jersey
      • Marlton, New Jersey, United States
        • Novum Investigator Site
      • Newport News, New Jersey, United States
        • Novum Investigator Site
    • New York
      • Poughkeepsie, New York, United States
        • Novum Investigator Site
    • North Carolina
      • Cary, North Carolina, United States
        • Novum Investigator Site
      • Charlotte, North Carolina, United States
        • Novum Investigator Site
      • High Point, North Carolina, United States
        • Novum Investigator Site
      • Raleigh, North Carolina, United States
        • Novum Investigator Site
      • Salisbury, North Carolina, United States
        • Novum Investigator Site
      • Wilmington, North Carolina, United States
        • Novum Investigator Site
      • Winstom-Salem, North Carolina, United States
        • Novum Investigator Site
    • Ohio
      • BeaverCreek, Ohio, United States
        • Novum Investigator Site
      • Centerville, Ohio, United States
        • Novum Investigator Site
      • Sylvania, Ohio, United States
        • Novum Investigator Site
    • South Carolina
      • Columbia, South Carolina, United States
        • Novum Investigator Site
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Novum Investigator Site
      • Germantown, Tennessee, United States
        • Novum Investigator Site
      • Hermitage, Tennessee, United States
        • Novum Investigator Site
    • Texas
      • Houston, Texas, United States
        • Novum Investigator Site
      • Longview, Texas, United States
        • Novum Investigator Site
      • San Antonio, Texas, United States
        • Novum Investigator Site
      • Sugarland, Texas, United States
        • Novum Investigator Site
    • Virginia
      • Charlottesville, Virginia, United States
        • Novum Investigator Site
      • Virginia Beach, Virginia, United States
        • Novum Investigator Site
    • Washington
      • Mountain Lake, Washington, United States
        • Novum Investigator 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  1. 1. Male or non-pregnant females aged 18 and older with a clinical diagnosis of chronic idiopathic constipation defined as, on average, < 3 spontaneous bowel movements (SBMs) per week for the past 6 months and confirmed by daily diary during the 14 day baseline lead-in period. An SBM is defined as any bowel movement that did not occur within 24 hours after rescue medication use.

  2. Have 1 or more of the following symptoms related to bowel movements for at least 6 months before the baseline visit and confirmed by daily diary during the 14 Day baseline period:

    • very hard (little balls) and/or hard stools for at least 25 percent of the bowel movements
    • sensation of incomplete evacuation following at least 25 percent of the bowel movements
    • straining at defecation at least a quarter of the time
  3. Women of child-bearing potential must have a negative pregnancy test prior to beginning therapy and agree to use effective contraceptive methods during the study.
  4. For patients aged < 50 years, documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed within the 5 years prior to dosing, showing no mechanical bowel obstruction or organic disorders of the large Bowel.
  5. For patients aged >/= 50 years, documentation of the results of either a barium enema with flexible sigmoidoscopy or colonoscopy performed within 1 year prior to dosing, showing no mechanical bowel obstruction or organic disorders of the large bowel.

Main Exclusion Criteria:

  1. Females who are Pregnant, breast feeding, or planning a pregnancy.
  2. Patients of any age with evidence of weight loss, anemia, or rectal bleeding AND without documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed during the 6 months prior to dosing.
  3. Patients that have documented mechanical bowel obstruction (e.g., bowel obstruction due to tumor, hernia), megacolon/megarectum, or diagnosis of pseudo-obstruction.
  4. Any known or suspected organic disorders of the large or small bowel (e.g., inflammatory bowel disease, ulcerative colitis, Crohn's Disease) or constipation secondary to a documented cause (e.g., surgery, bowel resection)or acute hernia.
  5. History of bowel resection.
  6. Patients who are regularly using medications know to cause constipation (narcotics, calcium channel blockers, tricyclic antidepressants).
  7. Hospitalized for any gastrointestinal or abdominal surgical procedure during the 3 months prior to dosing.
  8. Clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or clinically significant laboratory abnormalities.
  9. Use of a systemic antibiotic within 4 weeks prior to the Screening Visit.
  10. Participation in a study with any investigational medication within the past 30 days of screening for this study or previous participation in this study.

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: Double

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: AMITIZA
Manufactured by Sucampo Pharmaceuticals (24 mcg administered for 7 days)
Drug: Lubiprostone
24 mcg capsules
Placebo Comparator: Placebo
Manufactured by Anchen Pharmaceuticals (24 mcg administered for 7 days)
Drug: Placebo
24 mcg capsules
Experimental: Lubiprostone
Manufactured by Anchen Pharmaceuticals (24 mcg administered for 7 days)
Drug: Lubiprostone
24 mcg capsules

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
Primary Analysis
Time Frame: Day 8
Clinical equivalence of the Test and Reference treatments and the superiority of each active treatment over the Placebo in the change from baseline in mean number of SBM's during the 7 day randomization period of the study.
Day 8

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
Safety Analysis
Time Frame: Day 8
The frequency and severity of adverse events across treatment groups will be analyzed.
Day 8

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.
Anchen Pharmaceuticals, Inc

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.
Novum Pharmaceutical Research Services

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

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.
May 1, 2011

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.
June 1, 2012

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.
June 1, 2012

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).
June 10, 2011

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.
June 13, 2011

First Posted (Estimate)

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.
June 14, 2011

Study Record Updates

Last Update Posted (Estimate)

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.
July 12, 2012

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.
July 10, 2012

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.
July 1, 2012

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.
  • CS-01-2011
  • 71060001 (Other Identifier: Novum Pharmaceutical Research Services)

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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