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Evaluation of Clinical Equivalence Between Two Lubiprostone Products

NCT01372423 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 808

Last updated 2012-07-12

No results posted yet for this study

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

DRUG

Lubiprostone

24 mcg capsules

DRUG

Placebo

24 mcg capsules

Sponsors & Collaborators

  • Novum Pharmaceutical Research Services

    collaborator INDUSTRY

  • Anchen Pharmaceuticals, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01372423 on ClinicalTrials.gov