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The primary objective of this Phase 2 Study was to compare the safety of 3 liter(L) and 4 liter(L) split dose DCL-101 to split dose 4L GoLYTELY in patients preparing for colonoscopy, with secondary objectives to assess tolerability and bowel cleansing efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCL-101 | Experimental |
| |
| GoLytely | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCL-101 vs Golytely | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Graded Adverse Events | Scale: Common Terminology Criteria for Adverse Events, a 5-point scale with Grade 1 equal to "mild" and Grade 5 equal to "death" | 2-6 hours after completion of investigational agent administration |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Graded Adverse Events | Scale: Common Terminology Criteria for Adverse Events, a 5-point scale with Grade 1 equal to "mild" and Grade 5 equal to "death" | 1-2 days after completion of investigational agent administration |
| Incidence of Graded Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip N Calvillo | Alimentiv Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| Asheville Gastroenterology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33512795 | Derived | Bachwich DR, Lewis JD, Kowal VO, Jacobson BC, Calderwood AH, Kochman ML. A Phase 2 Randomized Trial of DCL-101, a Novel Pill-Based Colonoscopy Prep, vs 4L Polyethylene Glycol-Electrolyte Solution. Clin Transl Gastroenterol. 2020 Dec;11(12):e00264. doi: 10.14309/ctg.0000000000000264. |
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Scale: Common Terminology Criteria for Adverse Events, a 5-point scale with Grade 1 equal to "mild" and Grade 5 equal to "death" |
| 7 days after completion of investigational agent administration |
| Incidence of Serious Adverse Events | Scale: Events that are life-threatening, lead to hospitalization, cause permanent injury, or death | 2-6 hours after completion of investigational agent administration |
| Incidence of Serious Adverse Events | Scale: Events that are life-threatening, lead to hospitalization, cause permanent injury, or death | 1-2 days after completion of investigational agent administration |
| Incidence of Serious Adverse Events | Scale: Events that are life-threatening, lead to hospitalization, cause permanent injury, or death | 7 days after completion of investigational agent administration |
| Incidence of abnormal blood chemistries | Scale: Normal range, as established by study reference laboratory | 2-6 hours after completion of investigational agent administration |
| Incidence of abnormal blood chemistries | Scale: Normal range, as established by study reference laboratory | 1-2 days after completion of investigational agent administration |
| Incidence of abnormal blood chemistries | Scale: Normal range, as established by study reference laboratory | 7 days after completion of investigational agent administration |
| Incidence of abnormal urinalysis | Scale: Normal range, as established by study reference laboratory | 2-6 hours after completion of investigational agent administration |
| Incidence of abnormal urinalysis | Scale: Normal range, as established by study reference laboratory | 1-2 days after completion of investigational agent administration |
| Incidence of abnormal urinalysis | Scale: Normal range, as established by study reference laboratory | 7 days after completion of investigational agent administration |
| Incidence of clinically significant electrocardiogram (ECG) changes | Scale: Comparison with baseline ECG | 2-6 hours after completion of investigational agent administration |
| Incidence of clinically significant electrocardiogram (ECG) changes | Scale: Comparison with baseline ECG | 7 days after completion of investigational agent administration |
| Incidence of orthostatic hypotension | Scale: Defined as a drop of >20 mmHg of the systolic blood pressure, or a drop of > 10 mm Hg of the diastolic blood pressure, when going from a supine position to standing for 2 minutes, and measured standing. | 2-6 hours after completion of investigational agent administration |
| Incidence of orthostatic hypotension | Scale: Defined as a drop of >20 mmHg of the systolic blood pressure, or a drop of > 10 mm Hg of the diastolic blood pressure, when going from a supine position to standing for 2 minutes, and measured standing. | 1-2 days after completion of investigational agent administration |
| Incidence of orthostatic hypotension | Scale: Defined as a drop of >20 mmHg of the systolic blood pressure, or a drop of > 10 mm Hg of the diastolic blood pressure, when going from a supine position to standing for 2 minutes, and measured standing. | 7 days after completion of investigational agent administration |
| Between group difference in the aggregate tolerability score (ATS) of the Lawrance Colonoscopy Preparation Patient Tolerability Questionnaire | The Bowel-Preparation Tolerability Questionnaire by Lawrance et. al. (Lawrance Instrument) is a validated questionnaire asking patients to score nine symptoms during bowel preparation on a 5-point Likert scale. These symptom scores are summed for all nine symptoms to arrive at an aggregate tolerability score (ATS), with a lower ATS indicating better tolerability. | 2-6 hours after completion of investigational agent administration |
| Between group difference in score in individual aspects of the Lawrance Colonoscopy Preparation Patient Tolerability Questionnaire | Nine symptoms during bowel preparation on a 5-point Likert scale by patient | 2-6 hours after completion of investigational agent administration |
| Between group difference in the Symptom Score of the Mayo Clinic Bowel Prep Tolerability Questionnaire | The Mayo Clinic Bowel Prep Tolerability Questionnaire (Mayo Instrument) is a validated questionnaire containing 8 items including questions addressing tolerability, ability to consume the entire dose, and willingness to use again. Patients are also asked to score seven symptoms during bowel preparation on a 4-point Likert scale, which are averaged to determine a Symptom Score. | 2-6 hours after completion of investigational agent administration |
| Proportion of subjects compliant with 90% of the study treatment regimen | Consumption of a minimum of 90% of GoLYTELY solution or 90% of DCL-101 kit, as applicable | At time of colonoscopy |
| Proportion of subjects compliant with 100% of the study treatment regimen | Consumption of 100% of GoLYTELY solution or 100% of DCL-101 kit, as applicable. | At time of colonoscopy |
| The mean total score on the centrally read Ottawa Bowel Preparation Quality Scale (OBPQS) | At time of colonoscopy |
| The proportion of subjects achieving an OBPQS score of 2 or less (excellent), with no segment score greater than 1, on the centrally read OBPQS | At time of colonoscopy |
| The mean segmental scores and the mean colonic fluid quantity score from the centrally read OBPQS | At time of colonoscopy |
| The proportion of subjects achieving a score of 8 or greater on the Boston Bowel Preparation Scale (BBPS) | At time of colonoscopy |
| The proportion of subjects with segmental scores of 2 or greater on the BBPS for every one of the segments | At time of colonoscopy |
| The mean total score on the BBPS | At time of colonoscopy |
| The Aronchick score (excellent, good, fair, poor, unsatisfactory) | At time of colonoscopy |
| Asheville |
| North Carolina |
| 28801 |
| United States |
| Cumberland Research Associates LLC | Fayetteville | North Carolina | 28304 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Trial Management Associates | Wilmington | North Carolina | 28403 | United States |