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Completed

NCT Number: NCT01301781

BLI801 Laxative in Constipated Adults

A pilot study to evaluate the safety and efficacy of BLI801 vs. placebo in constipated adults.

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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

Advanced Clinical Research Institute, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

BLI801

Drug

BLI801 laxative - oral solution

Placebo

Drug

BLI801 placebo - oral solution

Primary outcomes

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

    Time frame: 3 hours

Secondary outcomes

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

    Time frame: 3 hours

  2. serum chemistry

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Braintree Laboratories

Industry

Registry information

Official study title

A Pilot Efficacy Evaluation of BLI801 Laxative in Constipated Adults

Important dates

Study start
2011
Primary completion
2011
First posted
Feb 23, 2011
Registry last updated
Oct 1, 2012

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.

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