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Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation

NCT01674530 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 909

Last updated 2014-04-03

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 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

Conditions

  • Chronic Idiopathic Constipation

Interventions

DRUG

Lubiprostone

24 mcg Capsules to be given in the experimental arm with Placebo Of AMITIZA

DRUG

Lubiprostone

24 mcg Capsules with placebo of Lubiprostone ( Manufactured by Dr Reddy's Laboratories Ltd)

DRUG

Placebo

24 mcg capsules of both experimental Lubiprostone and AMITIZA

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Ashis Patnaik, M.D · Dr. Reddy's Laboratories Limited

  • Shilpi Dhawan, M.D · Dr. Reddy's Laboratories Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-01-31
Completion
2014-03-31

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 NCT01674530 on ClinicalTrials.gov