Clinical trial NCT02910440: A Safety and Efficacy Study of DCL-101 Compared to GoLYTELY
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bowel Preparation Before Colonoscopy
Lead sponsor: Dark Canyon Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2016-09-22
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Graded Adverse Events
timeFrame: 2-6 hours after completion of investigational agent administration
Secondary outcomes:
measure: Incidence of Graded Adverse Events
timeFrame: 1-2 days after completion of investigational agent administration
measure: Incidence of Graded Adverse Events
timeFrame: 7 days after completion of investigational agent administration
measure: Incidence of Serious Adverse Events
timeFrame: 2-6 hours after completion of investigational agent administration
measure: Incidence of Serious Adverse Events
timeFrame: 1-2 days after completion of investigational agent administration
measure: Incidence of Serious Adverse Events
timeFrame: 7 days after completion of investigational agent administration
measure: Incidence of abnormal blood chemistries
timeFrame: 2-6 hours after completion of investigational agent administration
measure: Incidence of abnormal blood chemistries
timeFrame: 1-2 days after completion of investigational agent administration
measure: Incidence of abnormal blood chemistries
timeFrame: 7 days after completion of investigational agent administration
measure: Incidence of abnormal urinalysis
timeFrame: 2-6 hours after completion of investigational agent administration
measure: Incidence of abnormal urinalysis
timeFrame: 1-2 days after completion of investigational agent administration
measure: Incidence of abnormal urinalysis
timeFrame: 7 days after completion of investigational agent administration
measure: Incidence of clinically significant electrocardiogram (ECG) changes
timeFrame: 2-6 hours after completion of investigational agent administration
measure: Incidence of clinically significant electrocardiogram (ECG) changes
timeFrame: 7 days after completion of investigational agent administration
measure: Incidence of orthostatic hypotension
timeFrame: 2-6 hours after completion of investigational agent administration
measure: Incidence of orthostatic hypotension
timeFrame: 1-2 days after completion of investigational agent administration
measure: Incidence of orthostatic hypotension
timeFrame: 7 days after completion of investigational agent administration
measure: Between group difference in the aggregate tolerability score (ATS) of the Lawrance Colonoscopy Preparation Patient Tolerability Questionnaire
timeFrame: 2-6 hours after completion of investigational agent administration
measure: Between group difference in score in individual aspects of the Lawrance Colonoscopy Preparation Patient Tolerability Questionnaire
timeFrame: 2-6 hours after completion of investigational agent administration
measure: Between group difference in the Symptom Score of the Mayo Clinic Bowel Prep Tolerability Questionnaire
timeFrame: 2-6 hours after completion of investigational agent administration
measure: Proportion of subjects compliant with 90% of the study treatment regimen
timeFrame: At time of colonoscopy
measure: Proportion of subjects compliant with 100% of the study treatment regimen
timeFrame: At time of colonoscopy
measure: The mean total score on the centrally read Ottawa Bowel Preparation Quality Scale (OBPQS)
timeFrame: At time of colonoscopy
measure: 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
timeFrame: At time of colonoscopy
measure: The mean segmental scores and the mean colonic fluid quantity score from the centrally read OBPQS
timeFrame: At time of colonoscopy
measure: The proportion of subjects achieving a score of 8 or greater on the Boston Bowel Preparation Scale (BBPS)
timeFrame: At time of colonoscopy
measure: The proportion of subjects with segmental scores of 2 or greater on the BBPS for every one of the segments
timeFrame: At time of colonoscopy
measure: The mean total score on the BBPS
timeFrame: At time of colonoscopy
measure: The Aronchick score (excellent, good, fair, poor, unsatisfactory)
timeFrame: At time of colonoscopy
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Asheville
country: United States
facility: Asheville Gastroenterology
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates LLC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates
state: North Carolina
Study officials:
affiliation: Alimentiv Inc.
name: Philip N Calvillo
role: STUDY_CHAIR
References:
citation: 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.