A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults

September 24, 2009 updated by: Braintree Laboratories
To compare the safety and efficacy of BLI-801 administered at 4 dose levels in constipated adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States
    • Rhode Island
      • Cranston, Rhode Island, United States
      • Cumberland, Rhode Island, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects at least 18 years of age
  • Constipated according to ROME I criteria
  • Otherwise in good health, as determined by physical exam and medical history
  • If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
  • Negative urine pregnancy test at screening, if applicable
  • In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

  • Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
  • Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study
  • Subjects who are pregnant or lactating, or intending to become pregnant during the study
  • Subjects of childbearing potential who refuse a pregnancy test
  • Subjects who are allergic to any BLI-801 component.
  • Subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures
  • Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
BLI-801 Dose 1
Drug: BLI-801
Dose 1
Drug: BLI-801
Dose 2
Drug: BLI-801
Dose 3
Drug: BLI-801
Dose 4
Experimental: 2
BLI-801 Dose 2
Drug: BLI-801
Dose 1
Drug: BLI-801
Dose 2
Drug: BLI-801
Dose 3
Drug: BLI-801
Dose 4
Experimental: 3
BLI-801 Dose 3
Drug: BLI-801
Dose 1
Drug: BLI-801
Dose 2
Drug: BLI-801
Dose 3
Drug: BLI-801
Dose 4
Experimental: 4
BLI-801 Dose 4
Drug: BLI-801
Dose 1
Drug: BLI-801
Dose 2
Drug: BLI-801
Dose 3
Drug: BLI-801
Dose 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bowel Movement Count
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Braintree Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 28, 2007

First Posted (Estimate)

December 31, 2007

Study Record Updates

Last Update Posted (Estimate)

September 28, 2009

Last Update Submitted That Met QC Criteria

September 24, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BLI-801-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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