Evaluation of Clinical Equivalence Between Two Lubiprostone Products
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01372423
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 808 participants
Conditions and interventions
Conditions
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
- May 2011 (Type not available)
- Primary completion
- Jun 2012 (Actual)
- Completion
- Jun 2012 (Actual)
- Last update posted
- Jul 12, 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 12, 2012 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01372423 live on ClinicalTrials.gov.