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A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

NCT02481947 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 459

Last updated 2020-07-27

Study results available
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Summary

The purpose of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus lubiprostone in constipated adults.

Conditions

  • Chronic Idiopathic Constipation

Interventions

DRUG

BLI400 Laxative

21 gm BLI400 powder

DRUG

Lubiprostone

24 mcg capsule bid

Sponsors & Collaborators

  • Braintree Laboratories

    lead INDUSTRY

Principal Investigators

  • John McGowan, MPH · Braintree Laboratories, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

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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 NCT02481947 on ClinicalTrials.gov