Skip to main content
OpenTrials
Completed

NCT Number: NCT01687985

A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anaheim Clinical Trials, Anaheim, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BLI801 laxative - low dose

Drug

BLI801 laxative - oral solution

BLI801 laxative - high dose

Drug

BLI801 laxative - oral solution

Other names: BLI801

Primary outcomes

  1. Treatment Success

    Time frame: 4 weeks

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

Secondary outcomes

  1. serum chemistry

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Braintree Laboratories

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 19, 2012
Registry last updated
Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.