A Safety and Efficacy Evaluation of BLI801 Laxative in Co... | NCT01687985

Studies
A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults

NCT01687985

Sponsor

Braintree Laboratories

Status

Completed

Last Update Posted

Jul 16, 2014Estimated

Enrollment

81Actual

Phase

Phase 2

Conditions

Constipation

Interventions

BLI801 laxative - low dose
BLI801 laxative - high dose

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

Jul 2014

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

Aug 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Sep 14, 2012

First Submission Date that Met QC Criteria

Sep 14, 2012

First Posted Date

Sep 19, 2012Estimated

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

Jul 14, 2014

Certification/Extension First Submitted that Passed QC Review

Jul 14, 2014

Certification/Extension First Posted Date

Jul 16, 2014Estimated

Last Update Submitted Date

Jul 14, 2014

Last Update Posted Date

Jul 16, 2014Estimated

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

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BLI801 laxative - low dose	Experimental	BLI801 laxative - oral solution	Drug: BLI801 laxative - low dose
BLI801 laxative - high dose	Experimental	BLI801 laxative - oral solution	Drug: BLI801 laxative - high dose

Interventions

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

Measure	Description	Time Frame
Treatment Success	percent of patients experiencing a response in 3 out of 4 weeks of treatment	4 weeks

Measure	Description	Time Frame
serum chemistry		4 weeks

Eligibility Module

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

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

Facility	Status	City	State	ZIP	Country	Contacts
Anaheim Clinical Trials		Anaheim	California	92801	United States
Commonwealth Clinical Studies

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