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CompletedNCT00756548Updated Dec 27, 2013Results posted

BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

A Phase 3 interventional study of BLI850 and polyethylene glycol 3350 based bowel preparation in Colon Cancer, sponsored by Braintree Laboratories. Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-27.

Sponsored by Braintree Laboratories · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
386
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.

02

Conditions studied

  • Colon Cancer

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Keywords

  • colonoscopy
  • screening
03

In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's enrollment of 386 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Braintree Laboratories is the lead sponsor of 47 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.

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

Inclusion criteria

  1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication, including:

    • Evaluation of barium enema results
    • GI bleeding
    • Anemia of unknown etiology
    • Neoplastic disease surveillance
    • Abnormal Endosonography
    • Inflammatory bowel disease
    • Unknown diarrhea or constipation etiology
    • Polypectomy
    • Laser therapy
    • Routine screening
  2. At least 18 years of age.
  3. Otherwise in good health, as determined by physical exam and medical history.
  4. If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, intra-uterine device, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse).
  5. Negative urine pregnancy test at screening, if applicable.
  6. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon.
  2. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
  3. Subjects who are undergoing colonoscopy for foreign body removal or decompression.
  4. Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
  5. Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, colectomy, gastric bypass).
  6. Subjects who are pregnant or lactating, or intending to become pregnant during the study.
  7. Subjects of childbearing potential who refuse a pregnancy test.
  8. Subjects who are allergic to any preparation components
  9. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
  10. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
386 participants (actual)

Study arms

  • Experimental
    1

    multi-dose preparation for oral administration prior to colonoscopy

    Drug: BLI850

  • Active comparator
    2

    multi-dose preparation for oral administration prior to colonoscopy

    Drug: polyethylene glycol 3350 based bowel preparation

Interventions

  • DrugBLI850

    multi-dose preparation for oral administration prior to colonoscopy

  • Drugpolyethylene glycol 3350 based bowel preparation

    multi-dose preparation for oral administration prior to colonoscopy

06

What researchers measure

Primary outcomes

  1. Efficacy - Preparation Quality Using a 4 Point Scale

    Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent")

    Time frame: 2 days

Secondary outcomes

  1. Serum Chemistry Results (mEq/L)

    Change from Baseline

    Time frame: 2 days

  2. Hematology Results (%)

    Change from Baseline

    Time frame: 2 days

  3. Serum Chemistry Results (U/L)

    Change from Baseline

    Time frame: 2 days

  4. Serum Chemistry Results (mg/dL)

    Change from Baseline

    Time frame: 2 days

  5. Serum Chemistry Results (g/dL)

    Change from Baseline

    Time frame: 2 days

  6. Serum Chemistry Results - Glomerular Filtration Rate

    Change from Baseline

    Time frame: 2 days

  7. Hematology Results - Hemoglobin

    Change from Baseline

    Time frame: 2 days

  8. Hematology Results (1000/MCL)

    Change from Baseline

    Time frame: 2 days

  9. Hematology Results - Red Blood Cells

    Change from Baseline

    Time frame: 2 days

  10. Serum Chemistry Results (Osmolality)

    Change from Baseline

    Time frame: 2 days

07

Results

Posted Dec 27, 2013

Participant flow

Participant flow — Overall Study
MilestoneBLI850Polyethylene Glycol 3350 Based Bowel Preparation
Started186185
Completed184185
Not completed20

Outcome measures

PrimaryEfficacy - Preparation Quality Using a 4 Point Scale

Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent")

Time frame:
2 days
Reported as:
Number · percentage of participants
Efficacy - Preparation Quality Using a 4 Point Scale
percentage of participantsBLI850Polyethylene Glycol 3350 Based Bowel Preparation
Efficacy - Preparation Quality Using a 4 Point Scale94 (89 to 97)94 (89 to 97)
SecondarySerum Chemistry Results (mEq/L)

Change from Baseline

Time frame:
2 days
Reported as:
Mean · milliequivalent/L
Serum Chemistry Results (mEq/L)
milliequivalent/LBLI850Polyethylene Glycol 3350 Based Bowel Preparation
Anion Gap (mEq/L)0.39 ± 3.210.92 ± 2.66
Bicarbonate (mEq/L)-0.23 ± 2.9-1.69 ± 2.8
Chloride (mEq/L)-0.01 ± 2.61.58 ± 2.3
Magnesium (mEq/L)-0.01 ± 0.12-0.04 ± 0.14
Potassium (mEq/L)-0.15 ± 0.43-0.11 ± 0.43
Sodium (mEq/L)0.15 ± 2.40.81 ± 2.4
SecondaryHematology Results (%)

Change from Baseline

Time frame:
2 days
Reported as:
Mean · Percentage of cells
Hematology Results (%)
Percentage of cellsBLI850Polyethylene Glycol 3350 Based Bowel Preparation
Basophils-0.00 ± 0.48-0.01 ± 0.48
Eosinophils-0.06 ± 0.98-0.08 ± 0.88
Hematocrit0.31 ± 2.90.33 ± 2.5
Lymphocytes-0.83 ± 6.40.05 ± 6.1
Monocytes0.04 ± 1.870.07 ± 1.91
Neutrophils0.82 ± 7.3-0.03 ± 7.1
SecondarySerum Chemistry Results (U/L)

Change from Baseline

Time frame:
2 days
Reported as:
Mean · U/L
Serum Chemistry Results (U/L)
U/LBLI850Polyethylene Glycol 3350 Based Bowel Preparation
Alkaline phosphatase2.13 ± 10.50.67 ± 8.3
ALT4.34 ± 23.93.86 ± 8.6
Amylase-9.98 ± 11.8-6.55 ± 13.7
AST4.11 ± 8.44.22 ± 7.4
Creatine kinase-5.1 ± 724.2 ± 165
GGT0.01 ± 6.61.95 ± 10.4
SecondarySerum Chemistry Results (mg/dL)

Change from Baseline

Time frame:
2 days
Reported as:
Mean · mg/dL
Serum Chemistry Results (mg/dL)
mg/dLBLI850Polyethylene Glycol 3350 Based Bowel Preparation
Blood urea nitrogen-3.91 ± 3.9-3.01 ± 3.4
Calcium-0.14 ± 0.46-0.17 ± 0.47
Creatinine0.05 ± 0.140.00 ± 0.11
Direct bilirubin0.05 ± 0.070.04 ± 0.06
Glucose-3.78 ± 24-4.98 ± 30
Phosphate-0.20 ± 0.62-0.13 ± 0.62
Total bilirubin0.28 ± 0.340.15 ± 0.20
Uric acid0.33 ± 0.740.00 ± 0.73
SecondarySerum Chemistry Results (g/dL)

Change from Baseline

Time frame:
2 days
Reported as:
Mean · g/dL
Serum Chemistry Results (g/dL)
g/dLBLI850Polyethylene Glycol 3350 Based Bowel Preparation
Albumin0.07 ± 0.220.05 ± 0.20
Total protein0.13 ± 0.340.10 ± 0.32
SecondarySerum Chemistry Results - Glomerular Filtration Rate

Change from Baseline

Time frame:
2 days
Reported as:
Mean · ml/min
Serum Chemistry Results - Glomerular Filtration Rate
ml/minBLI850Polyethylene Glycol 3350 Based Bowel Preparation
Serum Chemistry Results - Glomerular Filtration Rate-0.53 ± 12.6-0.23 ± 11.1
SecondaryHematology Results - Hemoglobin

Change from Baseline

Time frame:
2 days
Reported as:
Mean · g/dL
Hematology Results - Hemoglobin
g/dLBLI850Polyethylene Glycol 3350 Based Bowel Preparation
Hematology Results - Hemoglobin0.22 ± 0.720.12 ± 0.65
SecondaryHematology Results (1000/MCL)

Change from Baseline

Time frame:
2 days
Reported as:
Mean · 1000/MCL
Hematology Results (1000/MCL)
1000/MCLBLI850Polyethylene Glycol 3350 Based Bowel Preparation
Platelets0.69 ± 38-1.00 ± 34
White Blood Cells-0.39 ± 1.65-0.48 ± 1.42
SecondaryHematology Results - Red Blood Cells

Change from Baseline

Time frame:
2 days
Reported as:
Mean · million/microliter
Hematology Results - Red Blood Cells
million/microliterBLI850Polyethylene Glycol 3350 Based Bowel Preparation
Hematology Results - Red Blood Cells0.07 ± 0.240.03 ± 0.22
SecondarySerum Chemistry Results (Osmolality)

Change from Baseline

Time frame:
2 days
Reported as:
Mean · mOsm/kg
Serum Chemistry Results (Osmolality)
mOsm/kgBLI850Polyethylene Glycol 3350 Based Bowel Preparation
Serum Chemistry Results (Osmolality)-2.12 ± 8.6-0.11 ± 7.9

Adverse events

Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BLI850—1/186 (0.5%)155/186 (83.3%)
Polyethylene Glycol 3350 Based Bowel Preparation—0/185 (0%)147/185 (79.5%)
Most frequent serious events
Most frequent serious events
EventBLI850Polyethylene Glycol 3350 Based Bowel Preparation
abdominal crampingGastrointestinal disorders1/1860/185
Most frequent other events
Most frequent other events
EventBLI850Polyethylene Glycol 3350 Based Bowel Preparation
Overall discomfortGastrointestinal disorders116/186121/185
Abdominal distensionGastrointestinal disorders96/186112/185
NauseaGastrointestinal disorders86/18672/185
Abdominal painGastrointestinal disorders70/18679/185
VomitingGastrointestinal disorders26/18613/185

Baseline characteristics

Intent-to-treat population

Age, Categorical
Age, Categorical(Participants)BLI850Polyethylene Glycol 3350 Based Bowel PreparationTotal
<=18 years000
Between 18 and 65 years144136280
>=65 years424991
Age, Continuous
Age, Continuous(years)BLI850Polyethylene Glycol 3350 Based Bowel PreparationTotal
Mean56.9 ± 11.456.8 ± 11.056.9 ± 11.2
Sex: Female, Male
Sex: Female, Male(Participants)BLI850Polyethylene Glycol 3350 Based Bowel PreparationTotal
Female85108193
Male10177178
Region of Enrollment
Region of Enrollment(participants)BLI850Polyethylene Glycol 3350 Based Bowel PreparationTotal
United States186185371
08

Study locations

12 sites
  • Advanced Clinical Research Institute
    Anaheim, California 92801, United States
  • Advanced Clinical Research Institute
    Orange, California 92869, United States
  • Indiana University Medical Center
    Indianapolis, Indiana 46202, United States
  • Gastrointestinal Associates
    Jackson, Mississippi 39202, United States
  • Options Health Research
    Tulsa, Oklahoma 74104, United States
  • Northwest Gastroenterology Clinic
    Portland, Oregon 97210, United States
  • Franklin Gastroenterology
    Franklin, Tennessee 37067, United States
  • Memphis Gastroenterology Group
    Germantown, Tennessee 38138, United States
  • The Frist Clinic
    Nashville, Tennessee 37203, United States
  • Houston Medical Research Associates
    Houston, Texas 77090, United States
  • Charlottesville Medical Research
    Charlottesville, Virginia 22911, United States
  • Northwest Gastroenterology Associates
    Bellevue, Washington 98004, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00756548
Lead sponsor
Braintree Laboratories
Responsible party
Sponsor
First posted
Sep 22, 2008
Start date
Aug 2008
Primary completion
Nov 2008
Results posted
Dec 27, 2013
Last update
Dec 27, 2013

Oversight

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

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