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A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults

Primary Purpose

Constipation

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

BLI801 laxative - low dose

BLI801 laxative - high dose

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female subjects at least 18 years of age

Constipated, defined by ROME definition:

Otherwise in good health, as determined by physical exam and medical history

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

Subjects who are allergic to any BLI801 component

Subjects currently taking narcotic analgesics or other medications known to cause constipation

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

Subjects with an active history of drug or alcohol abuse

Sites / Locations

Anaheim Clinical Trials
Commonwealth Clinical Studies
Clinsearch
Memphis Gastroenterology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

BLI801 laxative - low dose

BLI801 laxative - high dose

Arm Description

BLI801 laxative - oral solution

Outcomes

Primary Outcome Measures

Treatment Success

percent of patients experiencing a response in 3 out of 4 weeks of treatment

Secondary Outcome Measures

serum chemistry

Full Information

NCT ID

NCT01687985

First Posted

September 14, 2012

Last Updated

July 14, 2014

Sponsor

Braintree Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT01687985

Brief Title

A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults

Official Title

A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Braintree Laboratories

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A pilot study to evaluate the safety and efficacy of multiple BLI801 doses in constipated adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BLI801 laxative - low dose

Arm Type

Experimental

Arm Description

BLI801 laxative - oral solution

Arm Title

BLI801 laxative - high dose

Arm Type

Experimental

Arm Description

BLI801 laxative - oral solution

Intervention Type

Drug

Intervention Name(s)

BLI801 laxative - low dose

Intervention Description

BLI801 laxative - oral solution

Intervention Type

Drug

Intervention Name(s)

BLI801 laxative - high dose

Other Intervention Name(s)

BLI801

Intervention Description

BLI801 laxative - oral solution

Primary Outcome Measure Information:

Title

Treatment Success

Description

percent of patients experiencing a response in 3 out of 4 weeks of treatment

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

serum chemistry

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects at least 18 years of age Constipated, defined by ROME definition: Otherwise in good health, as determined by physical exam and medical history 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 Subjects who are allergic to any BLI801 component Subjects currently taking narcotic analgesics or other medications known to cause constipation 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 Subjects with an active history of drug or alcohol abuse

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John McGowan, MPH

Organizational Affiliation

Braintree Laboratories, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Anaheim Clinical Trials

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Commonwealth Clinical Studies

City

Brockton

State/Province

Massachusetts

ZIP/Postal Code

02302

Country

United States

Facility Name

Clinsearch

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37421

Country

United States

Facility Name

Memphis Gastroenterology

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults

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