BLI801 Laxative in Constipated Adults | NCT01301781

Studies
BLI801 Laxative in Constipated Adults

NCT01301781

Sponsor

Braintree Laboratories

Status

Completed

Last Update Posted

Oct 1, 2012Estimated

Enrollment

52Actual

Phase

Phase 2

Conditions

Constipation

Interventions

BLI801
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

May 2011Actual

Completion Date

Not provided

First Submitted Date

Feb 22, 2011

First Submission Date that Met QC Criteria

Feb 22, 2011

First Posted Date

Feb 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Sep 27, 2012

Certification/Extension First Submitted that Passed QC Review

Sep 27, 2012

Certification/Extension First Posted Date

Oct 1, 2012Estimated

Last Update Submitted Date

Sep 27, 2012

Last Update Posted Date

Oct 1, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BLI801 laxative	Experimental	BLI801 laxative - oral solution	Drug: BLI801
Placebo	Placebo Comparator	BLI801 placebo - oral solution	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BLI801	Drug	BLI801 laxative - oral solution	BLI801 laxative
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percentage of patients experiencing a bowel movement within 3 hours of the first study medication dose		3 hours

Secondary Outcomes

Measure	Description	Time Frame
percentage of patients experiencing a complete/satisfactory bowel movement (BM) within 3 hours of first dose		3 hours
serum chemistry		7 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Advanced Clinical Research Institute		Anaheim	California	92801	United States
Jupiter Research

Condition Browse Module

MeSH Terms

ID	Term
D003248	Constipation

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided