A Safety and Efficacy Study of DCL-101 Compared to GoLYTELY

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Investigator-blinded, Non-inferiority, Multicenter Study Evaluating the Safety and Efficacy of DCL-101 Compared to GoLYTELY in Adult Outpatients Undergoing Routine Colonoscopy

Conditions
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Bowel Preparation Before Colonoscopy

Intervention / Treatment
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* Drug: DCL-101 vs Golytely


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant, non-lactating females, 18 to 75 years of age. Females of child bearing potential must have a negative urine pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]). Routine, non-urgent, screening or surveillance colonoscopy is indicated and scheduled. Ability of subject to participate fully in all aspects of this clinical trial, including ability and willingness to swallow capsules. Informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization will be obtained and documented from all subjects prior to the start of any study-specific procedures. Exclusion Criteria: Known hypersensitivity or allergy to any of the components of GoLYTELY or DCL-101 Actual or suspected ileus, gastrointestinal obstruction or other major structural gastrointestinal disorders, esophageal stricture, gastric retention, bowel perforation, toxic colitis, ischemic colitis, infectious colitis, toxic mega-colon, or inflammatory bowel disease. Diverticulitis within the past 6 weeks Current or former tobacco users Prior colorectal surgery, esophageal surgery, or gastric surgery. This includes colectomy in the past, colostomy, ulcer surgery (antrectomy or pyloroplasty) or bariatric surgery, including lap band or fundoplication Chronic constipation, gastroparesis, esophageal motility disorders or other gut dysmotility disorders Requiring medications that cannot have the administration schedule safely altered to be compatible with bowel preparation Current or history within the past year of any ongoing clinically relevant electrocardiogram abnormalities Clinically significant electrolyte abnormalities during Screening, defined by the range of normal of the central laboratory Significant psychiatric illness Renal failure or chronic kidney disease (creatinine clearance less than 50 mL/min, unstable angina, acute coronary syndrome/congestive heart failure (New York Heart Association Functional Classification grade III or IV), ascites Received any investigational therapy within 60 days of randomization Blood donation within 56 days prior to randomization Plasma donation within 7 days prior to randomization Received luminal contrast agents such as barium or water-soluble oral contrast agent within 21 days prior to randomization Known to have an impaired gag reflex, or prone to regurgitation or aspiration Serious underlying disease that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study History of alcohol or drug abuse that in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures Pregnant or lactating women Prior enrolment in the current study and had received study treatment Cognitive barriers that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study Inability to either read or understand English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCL-101<br> | Drug: DCL-101 vs Golytely<br> <br> |
| Active Comparator: GoLytely<br> | Drug: DCL-101 vs Golytely<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |