A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults

Constipation Clinical Trial

Official title:

A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687985
• Other study ID #: BLI801-202
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2012
• Last updated: July 14, 2014
• Start date: August 2012
• Est. completion date: March 2013

Study information

• Verified date: July 2014
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• BLI801 laxative - low dose
BLI801 laxative - oral solution
• BLI801 laxative - high dose
BLI801 laxative - oral solution

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California
United States	Commonwealth Clinical Studies	Brockton	Massachusetts
United States	Clinsearch	Chattanooga	Tennessee
United States	Memphis Gastroenterology	Germantown	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Success	percent of patients experiencing a response in 3 out of 4 weeks of treatment	4 weeks	No
Secondary	serum chemistry		4 weeks	Yes