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| ID | Type | Description | Link |
|---|---|---|---|
| IND 78254 |
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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and size of polyps detected on examination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment |
|
| 2 | Placebo Comparator | split-dose PEG solution without dietary restrictions plus placebo pretreatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lubiprostone | Drug | lubiprostone 24mcg gelcap, 1 gelcap taken at noon the day prior to the colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Overall Cleanliness of the Prep as Measured by the Ottawa Scale | Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid | measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction With the Prep Measured by 5 Point Likert Scale | The participants completed a survey prior to the colonoscopy that graded their overall satisfaction with the bowel preparation. The subjects rated the survey questions on a 5-point Likert scale where 1 = severely distressing, 2=distressing, 3=bothersome, 4=mild, and 5=none. | measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Z Stengel, MD | Brooke Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12492209 | Background | Harewood GC, Wiersema MJ, Melton LJ 3rd. A prospective, controlled assessment of factors influencing acceptance of screening colonoscopy. Am J Gastroenterol. 2002 Dec;97(12):3186-94. doi: 10.1111/j.1572-0241.2002.07129.x. | |
| 16630226 | Background | Tan JJ, Tjandra JJ. Which is the optimal bowel preparation for colonoscopy - a meta-analysis. Colorectal Dis. 2006 May;8(4):247-58. doi: 10.1111/j.1463-1318.2006.00970.x. |
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Gastroenterology Clinic, Brooke Army Medical Center, Fort Sam Houston, TX October 2007 to January 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Amitiza | split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment |
| FG001 | Placebo | split-dose PEG solution without dietary restrictions plus placebo pretreatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Amitiza | split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment |
| BG001 | Placebo | split-dose PEG solution without dietary restrictions plus placebo pretreatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Overall Cleanliness of the Prep as Measured by the Ottawa Scale | Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid | Posted | Mean | Full Range | Ottawa Score | measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amitiza | split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment |
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This study may be limited by the recruitment of outpatients as the only study participants. The study results might have also been affected by limiting the indication for colonoscopy to colorectal cancer screening.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joel Stengel | Carl R Darnall Army Medical Center | 2545531804 | joel.stengel@us.army.mil |
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| ID | Term |
|---|---|
| D000068238 | Lubiprostone |
| ID | Term |
|---|---|
| D000527 | Alprostadil |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
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| placebo | Drug | placebo gelcap, taken at noon the day prior to the colonoscopy |
|
| Procedure Time | Procedure time refers to the total length of time required to complete the colonoscopy | measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period) |
| The Number of Polyps Detected on Examination | The number of colon polyps detected during the colonoscopy. | measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period) |
| 12838218 | Background | El Sayed AM, Kanafani ZA, Mourad FH, Soweid AM, Barada KA, Adorian CS, Nasreddine WA, Sharara AI. A randomized single-blind trial of whole versus split-dose polyethylene glycol-electrolyte solution for colonoscopy preparation. Gastrointest Endosc. 2003 Jul;58(1):36-40. doi: 10.1067/mge.2003.318. |
| 9788383 | Background | Church JM. Effectiveness of polyethylene glycol antegrade gut lavage bowel preparation for colonoscopy--timing is the key! Dis Colon Rectum. 1998 Oct;41(10):1223-5. doi: 10.1007/BF02258217. |
| 17413599 | Background | Lacy BE, Levy LC. Lubiprostone: a chloride channel activator. J Clin Gastroenterol. 2007 Apr;41(4):345-51. doi: 10.1097/01.mcg.0000225665.68920.df. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Amitiza |
split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment |
| OG001 | Placebo | split-dose PEG solution without dietary restrictions plus placebo pretreatment |
|
|
| Secondary | Patient Satisfaction With the Prep Measured by 5 Point Likert Scale | The participants completed a survey prior to the colonoscopy that graded their overall satisfaction with the bowel preparation. The subjects rated the survey questions on a 5-point Likert scale where 1 = severely distressing, 2=distressing, 3=bothersome, 4=mild, and 5=none. | Posted | Mean | Standard Deviation | linkert scale (1-5) | measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period) |
|
|
|
| Secondary | Procedure Time | Procedure time refers to the total length of time required to complete the colonoscopy | Posted | Mean | Standard Deviation | minutes | measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period) |
|
|
|
| Secondary | The Number of Polyps Detected on Examination | The number of colon polyps detected during the colonoscopy. | Posted | Number | number of polyps | measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period) |
|
|
|
| 0 |
| 94 |
| 0 |
| 94 |
| EG001 | Placebo | split-dose PEG solution without dietary restrictions plus placebo pretreatment | 0 | 94 | 0 | 94 |
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| D008055 |
| Lipids |