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NCT01372423 Clinical Trial

Evaluation of Clinical Equivalence Between Two Lubiprostone Products

Chronic Idiopathic Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01372423
Other study ID # CS-01-2011
Secondary ID 71060001
Status Completed
Phase Phase 3
First received June 10, 2011
Last updated July 10, 2012
Start date May 2011
Est. completion date June 2012

Study information
Verified date July 2012
Source Anchen Pharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lubiprostone
24 mcg capsules
• Placebo
24 mcg capsules
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Sponsors (2)
Lead Sponsor Collaborator
Anchen Pharmaceuticals, Inc Novum Pharmaceutical Research Services

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary Analysis Clinical equivalence of the Test and Reference treatments and the superiority of each active treatment over the Placebo in the change from baseline in mean number of SBM's during the 7 day randomization period of the study. Day 8 No
Secondary Safety Analysis The frequency and severity of adverse events across treatment groups will be analyzed. Day 8 Yes
See also
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