Colonoscopy
Conditions
Brief summary
The purpose of this study is to evaluate patient experience ratings of BLI800 in adult patients undergoing colonoscopy.
Detailed description
The objective of this study is to evaluate the patient satisfaction and preference of BLI800 in adult patients undergoing colonoscopy.
Interventions
DRUGBLI800
BLI800 Bowel Preparation
Sponsors
Braintree Laboratories
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Primary Inclusion Criteria: * Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication * 18 to 85 years of age (inclusive) * If female, and of child-bearing potential, is using an acceptable form of birth control * 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 Primary
Exclusion criteria
* Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon * Subjects with ongoing severe, acute inflammatory bowel disease * Subjects who had previous significant gastrointestinal surgeries * Subjects with known severe renal, hepatic or cardiac insufficiency * Subjects undergoing insulin therapy for any indication * Subjects with impaired consciousness that predisposes them to pulmonary aspiration * Subjects undergoing colonoscopy for foreign body removal and/or decompression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Preparation Consumption | 2 days | Question: How easy or difficult was it to consume the study preparation? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preparation Compliance | 2 days | Question: Were you able to consume the entire preparation as instructed? |
| Rating of Overall Experience | 2 days | — |
| Comparison to Prior Preparation | 2 days | How did this preparation experience compare to your prior experience? |
| Willingness to Repeat Preparation | 2 days | Would you ask your doctor for this preparation again if you need another colonoscopy in the future? |
| Refuse if Prescribed Again | 2 days | Would you refuse the same preparation again if it were to be prescribed to you in the future? |
| Rating of Aftertaste | 2 days | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BLI800 BLI800
BLI800: BLI800 Bowel Preparation | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | BLI800 |
|---|---|
| Age, Continuous | 50.3 years STANDARD_DEVIATION 12.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 40 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 5 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
Primary
Ease of Preparation Consumption
Question: How easy or difficult was it to consume the study preparation?
Time frame: 2 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BLI800 | Ease of Preparation Consumption | Very Difficult | 3 Participants |
| BLI800 | Ease of Preparation Consumption | Difficult | 5 Participants |
| BLI800 | Ease of Preparation Consumption | Tolerable | 15 Participants |
| BLI800 | Ease of Preparation Consumption | Easy | 7 Participants |
| BLI800 | Ease of Preparation Consumption | Very Easy | 8 Participants |
Secondary
Comparison to Prior Preparation
How did this preparation experience compare to your prior experience?
Time frame: 2 days
Population: Includes only those patients with a prior colonoscopy
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BLI800 | Comparison to Prior Preparation | Better | 12 Participants |
| BLI800 | Comparison to Prior Preparation | Worse | 2 Participants |
| BLI800 | Comparison to Prior Preparation | Same | 8 Participants |
Secondary
Preparation Compliance
Question: Were you able to consume the entire preparation as instructed?
Time frame: 2 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BLI800 | Preparation Compliance | Yes | 36 Participants |
| BLI800 | Preparation Compliance | No | 2 Participants |
Secondary
Rating of Aftertaste
Time frame: 2 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BLI800 | Rating of Aftertaste | Very Pleasant | 1 Participants |
| BLI800 | Rating of Aftertaste | Quite Pleasant | 6 Participants |
| BLI800 | Rating of Aftertaste | Neither Pleasant Nor Unpleasant | 15 Participants |
| BLI800 | Rating of Aftertaste | Quite Unpleasant | 11 Participants |
| BLI800 | Rating of Aftertaste | Very Unpleasant | 5 Participants |
Secondary
Rating of Overall Experience
Time frame: 2 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BLI800 | Rating of Overall Experience | Excellent | 9 Participants |
| BLI800 | Rating of Overall Experience | Good | 20 Participants |
| BLI800 | Rating of Overall Experience | Fair | 6 Participants |
| BLI800 | Rating of Overall Experience | Poor | 3 Participants |
| BLI800 | Rating of Overall Experience | Bad | 0 Participants |
Secondary
Refuse if Prescribed Again
Would you refuse the same preparation again if it were to be prescribed to you in the future?
Time frame: 2 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BLI800 | Refuse if Prescribed Again | Yes | 5 Participants |
| BLI800 | Refuse if Prescribed Again | No | 33 Participants |
Secondary
Willingness to Repeat Preparation
Would you ask your doctor for this preparation again if you need another colonoscopy in the future?
Time frame: 2 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BLI800 | Willingness to Repeat Preparation | Yes | 30 Participants |
| BLI800 | Willingness to Repeat Preparation | No | 8 Participants |