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Trial record 37 of 54 for:    colon cancer | ( Map: Mississippi, United States )

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

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ClinicalTrials.gov Identifier: NCT00756548
Recruitment Status : Completed
First Posted : September 22, 2008
Results First Posted : December 27, 2013
Last Update Posted : December 27, 2013
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Colon Cancer
Interventions Drug: BLI850
Drug: polyethylene glycol 3350 based bowel preparation
Enrollment 386
Recruitment Details  
Pre-assignment Details 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
Hide 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
Arm/Group Title BLI850 Polyethylene Glycol 3350 Based Bowel Preparation Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 186 185 371
Hide Baseline Analysis Population Description
Intent-to-treat population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 186 participants 185 participants 371 participants
<=18 years
0
   0.0%
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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 186 participants 185 participants 371 participants
56.9  (11.4) 56.8  (11.0) 56.9  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 186 participants 185 participants 371 participants
Female
85
  45.7%
108
  58.4%
193
  52.0%
Male
101
  54.3%
77
  41.6%
178
  48.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 186 participants 185 participants 371 participants
186 185 371
1.Primary Outcome
Title Efficacy - Preparation Quality Using a 4 Point Scale
Hide Description Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent")
Time Frame 2 days
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 185 185
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
94
(89 to 97)
94
(89 to 97)
2.Secondary Outcome
Title Serum Chemistry Results (mEq/L)
Hide Description Change from Baseline
Time Frame 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BLI850 Polyethylene Glycol 3350 Based Bowel Preparation
Hide Arm/Group Description:
multi-dose preparation for oral administration
multi-dose preparation for oral administration
Overall Number of Participants Analyzed 186 185
Mean (Standard Deviation)
Unit of Measure: milliequivalent/L
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 (%)
Hide Description Change from Baseline
Time Frame 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title BLI850 Polyethylene Glycol 3350 Based Bowel Preparation
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 186 185
Mean (Standard Deviation)
Unit of Measure: Percentage of cells
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)
Hide Description Change from Baseline
Time Frame 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BLI850 Polyethylene Glycol 3350 Based Bowel Preparation
Hide Arm/Group Description:
multi-dose preparation for oral administration
multi-dose preparation for oral administration
Overall Number of Participants Analyzed 186 185
Mean (Standard Deviation)
Unit of Measure: U/L
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)
Hide Description Change from Baseline
Time Frame 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BLI850 Polyethylene Glycol 3350 Based Bowel Preparation
Hide Arm/Group Description:
multi-dose preparation for oral administration
multi-dose preparation for oral administration
Overall Number of Participants Analyzed 186 185
Mean (Standard Deviation)
Unit of Measure: mg/dL
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)
Hide Description Change from Baseline
Time Frame 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BLI850 Polyethylene Glycol 3350 Based Bowel Preparation
Hide Arm/Group Description:
multi-dose preparation for oral administration
multi-dose preparation for oral administration
Overall Number of Participants Analyzed 186 185
Mean (Standard Deviation)
Unit of Measure: g/dL
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
Hide Description Change from Baseline
Time Frame 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BLI850 Polyethylene Glycol 3350 Based Bowel Preparation
Hide Arm/Group Description:
multi-dose preparation for oral administration
multi-dose preparation for oral administration
Overall Number of Participants Analyzed 186 185
Mean (Standard Deviation)
Unit of Measure: ml/min
-0.53  (12.6) -0.23  (11.1)
8.Secondary Outcome
Title Hematology Results - Hemoglobin
Hide Description Change from Baseline
Time Frame 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BLI850 Polyethylene Glycol 3350 Based Bowel Preparation
Hide Arm/Group Description:
multi-dose preparation for oral administration
multi-dose preparation for oral administration
Overall Number of Participants Analyzed 186 185
Mean (Standard Deviation)
Unit of Measure: g/dL
0.22  (0.72) 0.12  (0.65)
9.Secondary Outcome
Title Hematology Results (1000/MCL)
Hide Description Change from Baseline
Time Frame 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BLI850 Polyethylene Glycol 3350 Based Bowel Preparation
Hide Arm/Group Description:
multi-dose preparation for oral administration
multi-dose preparation for oral administration
Overall Number of Participants Analyzed 186 185
Mean (Standard Deviation)
Unit of Measure: 1000/MCL
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
Hide Description Change from Baseline
Time Frame 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BLI850 Polyethylene Glycol 3350 Based Bowel Preparation
Hide Arm/Group Description:
multi-dose preparation for oral administration
multi-dose preparation for oral administration
Overall Number of Participants Analyzed 186 185
Mean (Standard Deviation)
Unit of Measure: million/microliter
0.07  (0.24) 0.03  (0.22)
11.Secondary Outcome
Title Serum Chemistry Results (Osmolality)
Hide Description Change from Baseline
Time Frame 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BLI850 Polyethylene Glycol 3350 Based Bowel Preparation
Hide Arm/Group Description:
multi-dose preparation for oral administration
multi-dose preparation for oral administration
Overall Number of Participants Analyzed 186 185
Mean (Standard Deviation)
Unit of Measure: mOsm/kg
-2.12  (8.6) -0.11  (7.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BLI850 Polyethylene Glycol 3350 Based Bowel Preparation
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
BLI850 Polyethylene Glycol 3350 Based Bowel Preparation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BLI850 Polyethylene Glycol 3350 Based Bowel Preparation
Affected / at Risk (%) Affected / at Risk (%)
Total   1/186 (0.54%)   0/185 (0.00%) 
Gastrointestinal disorders     
abdominal cramping * 1  1/186 (0.54%)  0/185 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
BLI850 Polyethylene Glycol 3350 Based Bowel Preparation
Affected / at Risk (%) Affected / at Risk (%)
Total   155/186 (83.33%)   147/185 (79.46%) 
Gastrointestinal disorders     
Abdominal distension  1  96/186 (51.61%)  112/185 (60.54%) 
Abdominal pain  1  70/186 (37.63%)  79/185 (42.70%) 
Nausea  1  86/186 (46.24%)  72/185 (38.92%) 
Overall discomfort  1  116/186 (62.37%)  121/185 (65.41%) 
Vomiting  1  26/186 (13.98%)  13/185 (7.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: John McGowan, Director, Clinical Research
Organization: Braintree Laboratories, Inc.
Phone: 781-843-2202
Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT00756548     History of Changes
Other Study ID Numbers: BLI850-302
BLI850-302
First Submitted: September 18, 2008
First Posted: September 22, 2008
Results First Submitted: February 19, 2013
Results First Posted: December 27, 2013
Last Update Posted: December 27, 2013