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Completed

NCT Number: NCT00583154

A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults

To compare the safety and efficacy of BLI-801 administered at 4 dose levels in constipated adults.

Completed

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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

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

  • Male or female subjects at least 18 years of age
  • Constipated according to ROME I criteria
  • Otherwise in good health, as determined by physical exam and medical history
  • If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
  • Negative urine pregnancy test at screening, if applicable
  • In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

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 for the duration of the study
  • Subjects who are pregnant or lactating, or intending to become pregnant during the study
  • Subjects of childbearing potential who refuse a pregnancy test
  • Subjects who are allergic to any BLI-801 component.
  • 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

Treatment and study plan

BLI-801

Drug

Dose 1

Primary outcomes

  1. Bowel Movement Count

    Time frame: 24 hours

Secondary outcomes

  1. Adverse events

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Braintree Laboratories

Industry

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 31, 2007
Registry last updated
Sep 28, 2009

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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