Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation
Public ClinicalTrials.gov record NCT01674530. 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,Randomized , Double-blind,Double -Dummy Placebo-controlled,Parallel -Group, Multicenter Study to Evaluate the Clinical Equivalence of Lubiprostone 24 mcg Capsules ( Dr. Reddy's Laboratories Ltd.) 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 manufactured by Dr Reddy's Laboratories Ltd compared to the marketed formulation AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed Chronic Idiopathic Constipation
Study identification
- NCT ID
- NCT01674530
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 909 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
- Oct 2012 (Type not available)
- Primary completion
- Jan 2014 (Actual)
- Completion
- Mar 2014 (Actual)
- Last update posted
- Apr 3, 2014
2012 – 2014
United States locations
- U.S. sites
- 93
- U.S. states
- 23
- U.S. cities
- 74
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Radiant Research | Birmingham | Alabama | 35209 | — |
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | — |
| Clinical Research Associates | Huntsville | Alabama | 35801 | — |
| Drug Research Group, LLC | Mobile | Alabama | 36608 | — |
| Radiant Research | Scottsdale | Arizona | 85251 | — |
| Adobe Clinical Research , LLC | Tucson | Arizona | 85712 | — |
| Visions Clinical Research | Tucson | Arizona | 85712 | — |
| SC Clinical Research, Inc | Tucson | Arizona | 85741 | — |
| Preferred Research Partners | Little Rock | Arkansas | 72211 | — |
| Anaheim Clinical Trials | Anaheim | California | 92801 | — |
| Diagnamics Inc,477 N. El Camino Real,Suite A100 | Encinitas | California | 92024 | — |
| Advanced Medical Research Institute | Fresno | California | 93710 | — |
| Research Center of Fresno | Fresno | California | 93726 | — |
| Translational Research Group | North Hollywood | California | 91606 | — |
| Staywell Research | Northridge | California | v | — |
| Elias Research Associates | Orange | California | 92868 | — |
| Benchmark Research | Sacramento | California | 95816 | — |
| Medical Center for CR | San Diego | California | 92108 | — |
| Shawn K Hassler | San Francisco | California | — | — |
| SC Clinical Research, Inc ,1060 E. Foothill Blvd, Suite 204 | Upland | California | 91786 | — |
| Progressive Clinical Research | Vista | California | 92084 | — |
| Horizons Clinical Research Center | Denver | Colorado | 80220 | — |
| Radiant Research | Denver | Colorado | 80239 | — |
| Lynn Institute of Denver | Denver | Colorado | 80246 | — |
| Consultants of Clinical | Boynton Beach | Florida | 33426 | — |
| PAB Clinical Research | Brandon | Florida | 33511 | — |
| Elite Trials | Clearwater | Florida | 33761 | — |
| Health Care Family Rehabilitation and Research Center | Hialeah | Florida | 33012 | — |
| Medical Research Unlimited, LLC | Hialeah | Florida | 33012 | — |
| Health Awareness ,Inc | Jupiter | Florida | 33458 | — |
| Sunrise Medical Research | Lauderdale Lakes | Florida | 33319 | — |
| San Marcus Research Clinic | Miami | Florida | 33015 | — |
| Pharmax Research Clinic | Miami | Florida | 33126 | — |
| Community Research Foundation , Inc. | Miami | Florida | 33155 | — |
| Florida International Research | Miami | Florida | 33166 | — |
| Columbus Clinical Services | Miami | Florida | 33174 | — |
| South Medical Research Group , Inc | Miami | Florida | 33186 | — |
| Pharma Research International, Inc | Naples | Florida | 34109 | — |
| Pharma Research International, Inc | Naples | Florida | 34110 | — |
| Compass Research | Orlando | Florida | 32806 | — |
| Ormond Medical Arts Pharmaceutical | Ormond Beach | Florida | 32174 | — |
| Clinical Research of Central Florida | Plant City | Florida | 33563 | — |
| Accord Clinical Research,LLC | Port Orange | Florida | 32129 | — |
| Meridian Research | St. Petersburg | Florida | 33709 | — |
| Meridian Research | Tampa | Florida | 33606 | — |
| Clinical Research of Central Florida | Winter Haven | Florida | 33880 | — |
| Mount Vernon Clinical Research | Atlanta | Georgia | 30328 | — |
| Gastroenterology Consultants PC | Atlanta | Georgia | 30342 | — |
| Atlanta Gastroenterology Assoc | Marietta | Georgia | 30067 | — |
| Advanced Digestive Care Center , PC | Stockbridge | Georgia | 30281 | — |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | — |
| Heartland Research Associates | Newton | Kansas | 67114 | — |
| Heartland Research Associates | Wichita | Kansas | 67205 | — |
| Research Integrity | Owensboro | Kentucky | 42303 | — |
| East Jefferson Gastro | Metairie | Louisiana | 70006 | — |
| Boston Clinical Trials Inc | Boston | Massachusetts | 2131 | — |
| Beacon Clinical Research | Brockton | Massachusetts | 02301 | — |
| Bay State Clinical Trials, Inc. | Watertown | Massachusetts | 2472 | — |
| Clinical Research Institute | Chesterfield | Michigan | 48047 | — |
| Bayer Research | Kalamazoo | Michigan | 49009 | — |
| GI Associates and Endoscopy Center | Jackson | Mississippi | 39202 | — |
| Quality Clinical Research, Inc | Omaha | Nebraska | 68114 | — |
| Central Jersey Medical Research Center | Elizabeth | New Jersey | 07202 | — |
| University Hospital,150 Bergen Street,B-134 Pharmacy | Newark | New Jersey | 07103 | — |
| Hosc Inc. | Brooklyn | New York | 11206 | — |
| NY Scientific,189-11 Jamaica Ave | Hollis | New York | 11423 | — |
| Peters Medical Research | High Point | North Carolina | 27262 | — |
| Wake Research Associates | Raleigh | North Carolina | 27612 | — |
| PMG Research of Salisbury | Salisbury | North Carolina | 28144 | — |
| PMG Research of Wilmington | Wilmington | North Carolina | 28401 | — |
| PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina | 27103 | — |
| Valley Medical Research | Centerville | Ohio | 45459 | — |
| Rapid Medical Research , Inc | Cleveland | Ohio | 44122 | — |
| Radiant Research | Columbus | Ohio | 43212 | — |
| Great Lakes Gastroenterology | Mentor | Ohio | 44060 | — |
| Detweiler Family Medicine and Associates, PC | Lansdale | Pennsylvania | 19446 | — |
| Clinical Trials Research Services, LLC | Pittsburgh | Pennsylvania | 15206 | — |
| Radiant Research | Greer | South Carolina | 29650 | — |
| Clinsearch LLC | Chattanooga | Tennessee | 37421 | — |
| HCCA-CRS | Jackson | Tennessee | 38305 | — |
| KRK Medical Research | Dallas | Texas | 75230 | — |
| Gastroenterology Consultants P.A | Houston | Texas | 77034 | — |
| Clinical Trial Network | Houston | Texas | 77074 | — |
| Digestive Health Center | Pasadena | Texas | 77505 | — |
| Paragon Research Center | San Antonio | Texas | 78205 | — |
| Quality Research, Inc | San Antonio | Texas | 78209 | — |
| Sun Research | San Antonio | Texas | 78215 | — |
| Texas Medical Research Associates , LLC | San Antonio | Texas | 78238 | — |
| Breco Research | Sugarland | Texas | 77479 | — |
| Pioneer Research Solutions , Inc | Sugarland | Texas | 77479 | — |
| Charlottesville Medical Research Center | Charlottesville | Virginia | 22911 | — |
| BlueRidge Medical Research | Lynchburg | Virginia | 24502 | — |
| Health Research of Hampton Roads | Newport News | Virginia | 23606 | — |
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 NCT01674530, 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 Apr 3, 2014 · Synced Oct 17, 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 NCT01674530 live on ClinicalTrials.gov.