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ClinicalTrials.gov record
Completed Phase 3 Interventional

Evaluation of Clinical Equivalence Between Two Lubiprostone Products

ClinicalTrials.gov ID: NCT01372423

Public ClinicalTrials.gov record NCT01372423. 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 Jul 21, 2026, 2:16 PM 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 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

Study identification

NCT ID
NCT01372423
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Anchen Pharmaceuticals, Inc
Industry
Enrollment
808 participants

Conditions and interventions

Interventions

  • Lubiprostone Drug
  • Placebo Drug

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
Apr 30, 2011
Primary completion
May 31, 2012
Completion
May 31, 2012
Last update posted
Jul 11, 2012

2011 – 2012

United States locations

U.S. sites
79
U.S. states
27
U.S. cities
79
Facility City State ZIP Site status
Novum Investigator Site Dothan Alabama
Novum Investigator Site Huntsville Alabama
Novum Investigator Site Mobile Alabama
Novum Investigator Site Chandler Arizona
Novum Investigator Site Gilbert Arizona
Novum Investigator Site Mesa Arizona
Novum Investigator Site Phoenix Arizona
Novum Investigator Site Phoeniz Arizona
Novum Investigator Site Hot Springs Arkansas
Novum Investigator Site Little Rock Arkansas
Novum Investigator Site Mountain Home Arkansas
Novum Investigator Site Sherwood Arkansas
Novum Investigator Site Buena Park California
Novum Investigator Site Fresno California
Novum Investigator Site Garden Grove California
Novum Investigator Site La Palma California
Novum Investigator Site Long Beach California
Novum Investigator Site Sacremento California
Novum Investigator Site San Diego California
Novum Invesitgator Site San Ramon California
Novum Investigator Site Santa Ana California
Novum Investigator Site Westlake Village California
Novum Investigator Site Denver Colorado
Novum Investigator Site Wheat Ridge Colorado
Novum Investigator Site Adventura Florida
Novum Investigator Site Boyton Beach Florida
Novum Investigator Site Bradenton Florida
Novum Investigator Site Brookville Florida
Novum Investigator Site Clearwater Florida
Novum Investigator Site Deerfield Beach Florida
Novum Investigator Site Jupiter Florida
Novum Investigator Site Maimi Florida
Novum Investigator Site Miami Florida
Novum Investigator Site Niceville Florida
Novum Investigator Site Ormond Beach Florida
Novum Investigator Site Panama City Florida
Novum Investigator Site Port Orange Florida
Novum Investigator Site St. Petersburg Florida
Novum Investigator Site Tampa Florida
Novum Investigator Site West Palm Beach Florida
Novum Investigator Site Decauter Georgia
Novum Investigator Site Sandy Springs Georgia
Novum Investigator Site Stockbridge Georgia
Novum Investigator Site Lewiston Idaho
Novum Investigator Site Rockford Illinois
Novum Investigator Site Evansville Indiana
Novum Investigator Site Lexington Kentucky
Novum Investigator Site Shreveport Louisiana
Novum Invesitgator Site Hollywood Maryland
Novum Investigator Site Jackson Mississippi
Novum Investigator Site Mexico Missouri
Novum Investigator Site Washington Missouri
Novum Investigator Site Billings Montana
Novum Investigator Site Lincoln Nebraska
Novum Investigator Site Henderson Nevada
Novum Investigator Site Marlton New Jersey
Novum Investigator Site Newport News New Jersey
Novum Investigator Site Poughkeepsie New York
Novum Investigator Site Cary North Carolina
Novum Investigator Site Charlotte North Carolina
Novum Investigator Site High Point North Carolina
Novum Investigator Site Raleigh North Carolina
Novum Investigator Site Salisbury North Carolina
Novum Investigator Site Wilmington North Carolina
Novum Investigator Site Winstom-Salem North Carolina
Novum Investigator Site Beavercreek Ohio
Novum Investigator Site Centerville Ohio
Novum Investigator Site Sylvania Ohio
Novum Investigator Site Columbia South Carolina
Novum Investigator Site Chattanooga Tennessee
Novum Investigator Site Germantown Tennessee
Novum Investigator Site Hermitage Tennessee
Novum Investigator Site Houston Texas
Novum Investigator Site Longview Texas
Novum Investigator Site San Antonio Texas
Novum Investigator Site Sugarland Texas
Novum Investigator Site Charlottesville Virginia
Novum Investigator Site Virginia Beach Virginia
Novum Investigator Site Mountain Lake Washington

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 NCT01372423, 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 Jul 11, 2012 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01372423 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →