Evaluation of Clinical Equivalence Between Two Lubiprostone Products

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 compared to the marketed formulation AMITIZA® (lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed chronic idiopathic constipation.

Key facts

Study ID

NCT01372423

Run by

Anchen Pharmaceuticals, Inc

People needed

808

Starts

2011-05-01

Expected to finish

2012-06-01

Last updated by the study team

2012-07-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Novum Investigator Site — Huntsville, Alabama, United States
• Novum Investigator Site — Mobile, Alabama, United States
• Novum Investigator Site — 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 — 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 — 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 Invesitgator Site — San Ramon, California, United States
• Novum Investigator Site — Santa Ana, California, United States
• Novum Investigator Site — Westlake Village, California, United States
• Novum Investigator Site — Denver, Colorado, United States
• Novum Investigator Site — Wheat Ridge, Colorado, United States
• Novum Investigator Site — Adventura, Florida, United States
• Novum Investigator Site — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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