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

• Sponsor: Braintree Laboratories (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00756548
• Collaborator: (none)
• Enrollment: 386
• Locations: 12
• Arms: 2
• Patients Per Site: 32.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer	Drug: BLI850; Drug: polyethylene glycol 3350 based bowel preparation	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 386 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 multi-dose preparation for oral administration prior to colonoscopy	Drug: BLI850; multi-dose preparation for oral administration prior to colonoscopy
Active Comparator: 2 multi-dose preparation for oral administration prior to colonoscopy	Drug: polyethylene glycol 3350 based bowel preparation; multi-dose preparation for oral administration prior to colonoscopy

Outcome Measures

Primary Outcome Measures

1. Efficacy - Preparation Quality Using a 4 Point Scale [2 days]

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

Secondary Outcome Measures

1. Serum Chemistry Results (mEq/L) [2 days]

   Change from Baseline

2. Hematology Results (%) [2 days]

   Change from Baseline

3. Serum Chemistry Results (U/L) [2 days]

   Change from Baseline

4. Serum Chemistry Results (mg/dL) [2 days]

   Change from Baseline

5. Serum Chemistry Results (g/dL) [2 days]

   Change from Baseline

6. Serum Chemistry Results - Glomerular Filtration Rate [2 days]

   Change from Baseline

7. Hematology Results - Hemoglobin [2 days]

   Change from Baseline

8. Hematology Results (1000/MCL) [2 days]

   Change from Baseline

9. Hematology Results - Red Blood Cells [2 days]

   Change from Baseline

10. Serum Chemistry Results (Osmolality) [2 days]

    Change from Baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

1. At least 18 years of age.

2. Otherwise in good health, as determined by physical exam and medical history.

3. 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).

4. Negative urine pregnancy test at screening, if applicable.

5. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Clinical Research Institute	Anaheim	California	United States	92801
2	Advanced Clinical Research Institute	Orange	California	United States	92869
3	Indiana University Medical Center	Indianapolis	Indiana	United States	46202
4	Gastrointestinal Associates	Jackson	Mississippi	United States	39202
5	Options Health Research	Tulsa	Oklahoma	United States	74104
6	Northwest Gastroenterology Clinic	Portland	Oregon	United States	97210
7	Franklin Gastroenterology	Franklin	Tennessee	United States	37067
8	Memphis Gastroenterology Group	Germantown	Tennessee	United States	38138
9	The Frist Clinic	Nashville	Tennessee	United States	37203
10	Houston Medical Research Associates	Houston	Texas	United States	77090
11	Charlottesville Medical Research	Charlottesville	Virginia	United States	22911
12	Northwest Gastroenterology Associates	Bellevue	Washington	United States	98004

Sponsors and Collaborators

• Braintree Laboratories

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Braintree Laboratories
• ClinicalTrials.gov Identifier: NCT00756548
• Other Study ID Numbers: BLI850-302; BLI850-302
• First Posted: Sep 22, 2008
• Last Update Posted: Dec 27, 2013
• Last Verified: Dec 1, 2013

• Keywords provided by Braintree Laboratories: colonoscopy; screening
• Additional relevant MeSH terms: Colonic Neoplasms; Polyethylene glycol 3350

Study Results

Participant Flow

Pre-assignment Detail	386 subjects were randomized. 15 patients did not take the preparation are were excluded from the Intent-to-treat population.

Arm/Group Title	BLI850	Polyethylene Glycol 3350 Based Bowel Preparation
Arm/Group Description	single administration oral preparation - split dose	single administration oral preparation - split dose
Period Title: Overall Study
STARTED	186	185
COMPLETED	184	185
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	BLI850	Polyethylene Glycol 3350 Based Bowel Preparation	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	186	185	371
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	144 77.4%	136 73.5%	280 75.5%
>=65 years	42 22.6%	49 26.5%	91 24.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.9 (11.4)	56.8 (11.0)	56.9 (11.2)
Sex: Female, Male (Count of Participants)
Female	85 45.7%	108 58.4%	193 52%
Male	101 54.3%	77 41.6%	178 48%
Region of Enrollment (participants) [Number]
United States	186 100%	185 100%	371 100%

Outcome Measures

1. Primary Outcome

Title	Efficacy - Preparation Quality Using a 4 Point Scale
Description	Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent")
Time Frame	2 days

Outcome Measure Data

Analysis Population Description

186 patients were included in the BLI850 intent-to-treat population. One patient took the preparation but did not undergo colonoscopy due to insurance coverage issues. This patient is excluded from all efficacy analyses.

Arm/Group Title	BLI850	Polyethylene Glycol 3350 Based Bowel Preparation
Arm/Group Description
Measure Participants	185	185
Number (95% Confidence Interval) [percentage of participants]	94 50.5%	94 50.8%

2. Secondary Outcome

Title	Serum Chemistry Results (mEq/L)
Description	Change from Baseline
Time Frame	2 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BLI850	Polyethylene Glycol 3350 Based Bowel Preparation
Arm/Group Description	multi-dose preparation for oral administration	multi-dose preparation for oral administration
Measure Participants	186	185
Anion Gap (mEq/L)	0.39 (3.21)	0.92 (2.66)
Bicarbonate (mEq/L)	-0.23 (2.9)	-1.69 (2.8)
Chloride (mEq/L)	-0.01 (2.6)	1.58 (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 (2.4)	0.81 (2.4)

3. Secondary Outcome

Title	Hematology Results (%)
Description	Change from Baseline
Time Frame	2 days

Outcome Measure Data

Analysis Population Description

Intent to treat population

Arm/Group Title	BLI850	Polyethylene Glycol 3350 Based Bowel Preparation
Arm/Group Description
Measure Participants	186	185
Basophils	-0.00 (0.48)	-0.01 (0.48)
Eosinophils	-0.06 (0.98)	-0.08 (0.88)
Hematocrit	0.31 (2.9)	0.33 (2.5)
Lymphocytes	-0.83 (6.4)	0.05 (6.1)
Monocytes	0.04 (1.87)	0.07 (1.91)
Neutrophils	0.82 (7.3)	-0.03 (7.1)

4. Secondary Outcome

Title	Serum Chemistry Results (U/L)
Description	Change from Baseline
Time Frame	2 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BLI850	Polyethylene Glycol 3350 Based Bowel Preparation
Arm/Group Description	multi-dose preparation for oral administration	multi-dose preparation for oral administration
Measure Participants	186	185
Alkaline phosphatase	2.13 (10.5)	0.67 (8.3)
ALT	4.34 (23.9)	3.86 (8.6)
Amylase	-9.98 (11.8)	-6.55 (13.7)
AST	4.11 (8.4)	4.22 (7.4)
Creatine kinase	-5.1 (72)	4.2 (165)
GGT	0.01 (6.6)	1.95 (10.4)

5. Secondary Outcome

Title	Serum Chemistry Results (mg/dL)
Description	Change from Baseline
Time Frame	2 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BLI850	Polyethylene Glycol 3350 Based Bowel Preparation
Arm/Group Description	multi-dose preparation for oral administration	multi-dose preparation for oral administration
Measure Participants	186	185
Blood urea nitrogen	-3.91 (3.9)	-3.01 (3.4)
Calcium	-0.14 (0.46)	-0.17 (0.47)
Creatinine	0.05 (0.14)	0.00 (0.11)
Direct bilirubin	0.05 (0.07)	0.04 (0.06)
Glucose	-3.78 (24)	-4.98 (30)
Phosphate	-0.20 (0.62)	-0.13 (0.62)
Total bilirubin	0.28 (0.34)	0.15 (0.20)
Uric acid	0.33 (0.74)	0.00 (0.73)

6. Secondary Outcome

Title	Serum Chemistry Results (g/dL)
Description	Change from Baseline
Time Frame	2 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BLI850	Polyethylene Glycol 3350 Based Bowel Preparation
Arm/Group Description	multi-dose preparation for oral administration	multi-dose preparation for oral administration
Measure Participants	186	185
Albumin	0.07 (0.22)	0.05 (0.20)
Total protein	0.13 (0.34)	0.10 (0.32)

7. Secondary Outcome

Title	Serum Chemistry Results - Glomerular Filtration Rate
Description	Change from Baseline
Time Frame	2 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BLI850	Polyethylene Glycol 3350 Based Bowel Preparation
Arm/Group Description	multi-dose preparation for oral administration	multi-dose preparation for oral administration
Measure Participants	186	185
Mean (Standard Deviation) [ml/min]	-0.53 (12.6)	-0.23 (11.1)

8. Secondary Outcome

Title	Hematology Results - Hemoglobin
Description	Change from Baseline
Time Frame	2 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BLI850	Polyethylene Glycol 3350 Based Bowel Preparation
Arm/Group Description	multi-dose preparation for oral administration	multi-dose preparation for oral administration
Measure Participants	186	185
Mean (Standard Deviation) [g/dL]	0.22 (0.72)	0.12 (0.65)

9. Secondary Outcome

Title	Hematology Results (1000/MCL)
Description	Change from Baseline
Time Frame	2 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BLI850	Polyethylene Glycol 3350 Based Bowel Preparation
Arm/Group Description	multi-dose preparation for oral administration	multi-dose preparation for oral administration
Measure Participants	186	185
Platelets	0.69 (38)	-1.00 (34)
White Blood Cells	-0.39 (1.65)	-0.48 (1.42)

10. Secondary Outcome

Title	Hematology Results - Red Blood Cells
Description	Change from Baseline
Time Frame	2 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BLI850	Polyethylene Glycol 3350 Based Bowel Preparation
Arm/Group Description	multi-dose preparation for oral administration	multi-dose preparation for oral administration
Measure Participants	186	185
Mean (Standard Deviation) [million/microliter]	0.07 (0.24)	0.03 (0.22)

11. Secondary Outcome

Title	Serum Chemistry Results (Osmolality)
Description	Change from Baseline
Time Frame	2 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BLI850	Polyethylene Glycol 3350 Based Bowel Preparation
Arm/Group Description	multi-dose preparation for oral administration	multi-dose preparation for oral administration
Measure Participants	186	185
Mean (Standard Deviation) [mOsm/kg]	-2.12 (8.6)	-0.11 (7.9)

Adverse Events

Arm/Group Title	BLI850		Polyethylene Glycol 3350 Based Bowel Preparation
Arm/Group Description
All Cause Mortality
	BLI850		Polyethylene Glycol 3350 Based Bowel Preparation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	BLI850		Polyethylene Glycol 3350 Based Bowel Preparation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/186 (0.5%)		0/185 (0%)
Gastrointestinal disorders
abdominal cramping	1/186 (0.5%)		0/185 (0%)
Other (Not Including Serious) Adverse Events
	BLI850		Polyethylene Glycol 3350 Based Bowel Preparation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	155/186 (83.3%)		147/185 (79.5%)
Gastrointestinal disorders
Abdominal distension	96/186 (51.6%)		112/185 (60.5%)
Abdominal pain	70/186 (37.6%)		79/185 (42.7%)
Nausea	86/186 (46.2%)		72/185 (38.9%)
Overall discomfort	116/186 (62.4%)		121/185 (65.4%)
Vomiting	26/186 (14%)		13/185 (7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 360 days from the time submitted to the sponsor for review. The sponsor cannot extent the embargo.