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

Dark Canyon Laboratories, LLC46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bowel Preparation Before Colonoscopy

Interventions

DCL-101 vs GolytelyDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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 \[defined as a minimum of one year since the last menstrual period\]). 2. Routine, non-urgent, screening or surveillance colonoscopy is indicated and scheduled. 3. Ability of subject to participate fully in all aspects of this clinical trial, including ability and willingness to swallow capsules. 4. 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: 1. Known hypersensitivity or allergy to any of the components of GoLYTELY or DCL-101 2. 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 3. Current or former tobacco users 4. 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 5. Chronic constipation, gastroparesis, esophageal motility disorders or other gut dysmotility disorders 6. Requiring medications that cannot have the administration schedule safely altered to be compatible with bowel preparation 7. Current or history within the past year of any ongoing clinically relevant electrocardiogram abnormalities 8. Clinically significant electrolyte abnormalities during Screening, defined by the range of normal of the central laboratory 9. Significant psychiatric illness 10. 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 11. Received any investigational therapy within 60 days of randomization 12. Blood donation within 56 days prior to randomization 13. Plasma donation within 7 days prior to randomization 14. Received luminal contrast agents such as barium or water-soluble oral contrast agent within 21 days prior to randomization 15. Known to have an impaired gag reflex, or prone to regurgitation or aspiration 16. Serious underlying disease that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study 17. 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 18. Pregnant or lactating women 19. Prior enrolment in the current study and had received study treatment 20. Cognitive barriers that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study 21. Inability to either read or understand English

Locations (5)

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Asheville Gastroenterology

Asheville, North Carolina, United States

Cumberland Research Associates LLC

Fayetteville, North Carolina, United States

Wake Research Associates

Raleigh, North Carolina, United States

Outcomes

Primary Outcomes

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"

Time frame: 2-6 hours after completion of investigational agent administration

Secondary Outcomes

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"

Time frame: 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"

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 7 days after completion of investigational agent administration

Incidence of abnormal blood chemistries

Data from ClinicalTrials.gov

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Trial Management Associates

Wilmington, North Carolina, United States

Scale: Normal range, as established by study reference laboratory

Time frame: 2-6 hours after completion of investigational agent administration

Incidence of abnormal blood chemistries

Scale: Normal range, as established by study reference laboratory

Time frame: 1-2 days after completion of investigational agent administration

Incidence of abnormal blood chemistries

Scale: Normal range, as established by study reference laboratory

Time frame: 7 days after completion of investigational agent administration

Incidence of abnormal urinalysis

Scale: Normal range, as established by study reference laboratory

Time frame: 2-6 hours after completion of investigational agent administration

Incidence of abnormal urinalysis

Scale: Normal range, as established by study reference laboratory

Time frame: 1-2 days after completion of investigational agent administration

Incidence of abnormal urinalysis

Scale: Normal range, as established by study reference laboratory

Time frame: 7 days after completion of investigational agent administration

Incidence of clinically significant electrocardiogram (ECG) changes

Scale: Comparison with baseline ECG

Time frame: 2-6 hours after completion of investigational agent administration

Incidence of clinically significant electrocardiogram (ECG) changes

Scale: Comparison with baseline ECG

Time frame: 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.

Time frame: 2-6 hours after completion of investigational agent administration

Incidence of orthostatic hypotension

Time frame: 1-2 days after completion of investigational agent administration

Incidence of orthostatic hypotension

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: At time of colonoscopy

The mean total score on the centrally read Ottawa Bowel Preparation Quality Scale (OBPQS)

Time frame: 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

Time frame: At time of colonoscopy

The mean segmental scores and the mean colonic fluid quantity score from the centrally read OBPQS

Time frame: At time of colonoscopy

The proportion of subjects achieving a score of 8 or greater on the Boston Bowel Preparation Scale (BBPS)

Time frame: At time of colonoscopy

The proportion of subjects with segmental scores of 2 or greater on the BBPS for every one of the segments

Time frame: At time of colonoscopy

The mean total score on the BBPS

Time frame: At time of colonoscopy

The Aronchick score (excellent, good, fair, poor, unsatisfactory)

Time frame: At time of colonoscopy