NCT01372423

Evaluation of Clinical Equivalence Between Two Lubiprostone Products

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 808 (actual)
• Sponsor: Anchen Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Idiopathic Constipation

Interventions

Type	Name	Description
DRUG	Lubiprostone	24 mcg capsules
DRUG	Placebo	24 mcg capsules

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-06-14
• Last updated: 2012-07-12

Locations

79 sites across 1 country: United States