Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation
Completed · Phase 3 · Has a placebo group
Conditions studied: Chronic Idiopathic Constipation
In brief
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
Key facts
- Study ID
- NCT01674530
- Run by
- Dr. Reddy's Laboratories Limited
- People needed
- 909
- Starts
- 2012-10-01
- Expected to finish
- 2014-03-01
- Last updated by the study team
- 2014-04-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Digestive Health Specialists of the Southeast — Dothan, Alabama, United States
- Clinical Research Associates — Huntsville, Alabama, United States
- Drug Research Group, LLC — Mobile, Alabama, United States
- Radiant Research — Scottsdale, Arizona, United States
- Adobe Clinical Research , LLC — Tucson, Arizona, United States
- Visions Clinical Research — Tucson, Arizona, United States
- SC Clinical Research, Inc — Tucson, Arizona, United States
- Preferred Research Partners — Little Rock, Arkansas, United States
- Anaheim Clinical Trials — Anaheim, California, United States
- Diagnamics Inc,477 N. El Camino Real,Suite A100 — Encinitas, California, United States
- Advanced Medical Research Institute — Fresno, California, United States
- Research Center of Fresno — Fresno, California, United States
- Translational Research Group — North Hollywood, California, United States
- Staywell Research — Northridge, California, United States
- Elias Research Associates — Orange, California, United States
- Benchmark Research — Sacramento, California, United States
- Medical Center for CR — San Diego, California, United States
- Shawn K Hassler — San Francisco, California, United States
- SC Clinical Research, Inc ,1060 E. Foothill Blvd, Suite 204 — Upland, California, United States
- Progressive Clinical Research — Vista, California, United States
- Horizons Clinical Research Center — Denver, Colorado, United States
- Radiant Research — Denver, Colorado, United States
- Lynn Institute of Denver — Denver, Colorado, United States
- Consultants of Clinical — Boynton Beach, Florida, United States
- Radiant Research — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.