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CompletedNCT00503815Updated Dec 27, 2007

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

A Phase 3 interventional study of BLI-800 and Polyethylene glycol 3350 based bowel preparation in Colonoscopy, sponsored by Braintree Laboratories. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-12-27.

Sponsored by Braintree Laboratories (part of Sebela Pharmaceuticals) · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Colonoscopy

Keywords

  • colonoscopy
  • bowel preparation
  • prep
03

In context

Lead sponsor

Braintree Laboratories is the lead sponsor of 49 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

First submitted before Braintree Laboratories became part of Sebela Pharmaceuticals.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
360 participants (estimated)
06

What researchers measure

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

07

Study locations

10 sites
  • Anaheim, California 92801, United States
  • Orange, California 92869, United States
  • Jackson, Mississippi 39202, United States
  • Portland, Oregon 97210, United States
  • Franklin, Tennessee 37067, United States
  • Germantown, Tennessee 38138, United States
  • Jackson, Tennessee, United States
  • Nashville, Tennessee 37203, United States
  • Houston, Texas 77090, United States
  • Bellevue, Washington 98004, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2007, a primary completion of Nov 2007 and a completion of Nov 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2007
First posted
Jul 19, 2007
Start
Jul 2007
Primary completionActual
Nov 2007
CompletionActual
Nov 2007
Last update
Dec 27, 2007
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 27, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00503815
First posted
Jul 19, 2007
Start date
Jul 2007
Primary completion
Nov 2007
Completion
Nov 2007
Last update
Dec 27, 2007

Study contacts

John D McGowan, B.S.
study director · Braintree Laboratories, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: BLI800

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