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OpenTrials
Completed

NCT Number: NCT00503815

BLI-800-302: BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

This is a randomized, parallel, multi-center, single-blind study, comparing BLI-800 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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 outpatients who are undergoing colonoscopy for a routinely accepted indication, including:

Evaluation of BE results GI bleeding Anemia of unknown etiology Neoplastic disease surveillance Endosonography Inflammatory bowel disease Unknown diarrhea or constipation etiology Polypectomy Laser therapy Routine Screening

  • At least 18 years of age
  • 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, 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, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon.
  • Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
  • Subjects who are undergoing colonoscopy for foreign body removal and decompression.
  • Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
  • Subjects with a history of renal or hepatic insufficiency or congestive heart failure.
  • Subjects who had previous gastrointestinal surgeries
  • 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 preparation components
  • 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-800

Drug

Polyethylene glycol 3350 based bowel preparation

Drug

Primary outcomes

  1. Efficacy - preparation quality using a 4 point scale

    Time frame: 2-Day

Secondary outcomes

  1. Safety-preparation related side effects; laboratory analysis

    Time frame: 30-Day

Sponsors and collaborators

Lead sponsor

Braintree Laboratories

Industry

Registry information

Official study title

A Safety and Efficacy Evaluation of BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 19, 2007
Registry last updated
Dec 27, 2007

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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