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BLI801 Laxative in Constipated Adults

Primary Purpose

Constipation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BLI801
Placebo
Sponsored by
Braintree Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  • Constipated, defined by ROME III definition
  • Subject has < 3 satisfactory BMs during the run-in period

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 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

  • Advanced Clinical Research Institute
  • Jupiter Research
  • United Medical Research
  • Long Island GI Research Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BLI801 laxative

Placebo

Arm Description

BLI801 laxative - oral solution

BLI801 placebo - oral solution

Outcomes

Primary Outcome Measures

percentage of patients experiencing a bowel movement within 3 hours of the first study medication dose

Secondary Outcome Measures

percentage of patients experiencing a complete/satisfactory bowel movement (BM) within 3 hours of first dose
serum chemistry

Full Information

First Posted
February 22, 2011
Last Updated
September 27, 2012
Sponsor
Braintree Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01301781
Brief Title
BLI801 Laxative in Constipated Adults
Official Title
A Pilot Efficacy Evaluation of BLI801 Laxative in Constipated Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Braintree Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A pilot study to evaluate the safety and efficacy of BLI801 vs. placebo 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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BLI801 laxative
Arm Type
Experimental
Arm Description
BLI801 laxative - oral solution
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
BLI801 placebo - oral solution
Intervention Type
Drug
Intervention Name(s)
BLI801
Intervention Description
BLI801 laxative - oral solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
BLI801 placebo - oral solution
Primary Outcome Measure Information:
Title
percentage of patients experiencing a bowel movement within 3 hours of the first study medication dose
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
percentage of patients experiencing a complete/satisfactory bowel movement (BM) within 3 hours of first dose
Time Frame
3 hours
Title
serum chemistry
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Constipated, defined by ROME III definition Subject has < 3 satisfactory BMs during the run-in period 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 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
Facility Information:
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Jupiter Research
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
United Medical Research
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
Long Island GI Research Group
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States

12. IPD Sharing Statement

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BLI801 Laxative in Constipated Adults

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