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

Bowel Preparation Before Colonoscopy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910440
• Other study ID #: DCL-101-201
• Status: Completed
• Phase: Phase 2
• Start date: January 2017
• Est. completion date: November 2017

Study information

• Verified date: May 2020
• Source: Dark Canyon Laboratories, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bowel Preparation Before Colonoscopy

Intervention

Drug:
• DCL-101 vs Golytely

Locations

Country	Name	City	State
United States	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	Trial Management Associates	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Dark Canyon Laboratories, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of abnormal blood chemistries	Scale: Normal range, as established by study reference laboratory	2-6 hours after completion of investigational agent administration
Secondary	Incidence of abnormal blood chemistries	Scale: Normal range, as established by study reference laboratory	1-2 days after completion of investigational agent administration
Secondary	Incidence of abnormal blood chemistries	Scale: Normal range, as established by study reference laboratory	7 days after completion of investigational agent administration
Secondary	Incidence of abnormal urinalysis	Scale: Normal range, as established by study reference laboratory	2-6 hours after completion of investigational agent administration
Secondary	Incidence of abnormal urinalysis	Scale: Normal range, as established by study reference laboratory	1-2 days after completion of investigational agent administration
Secondary	Incidence of abnormal urinalysis	Scale: Normal range, as established by study reference laboratory	7 days after completion of investigational agent administration
Secondary	Incidence of clinically significant electrocardiogram (ECG) changes	Scale: Comparison with baseline ECG	2-6 hours after completion of investigational agent administration
Secondary	Incidence of clinically significant electrocardiogram (ECG) changes	Scale: Comparison with baseline ECG	7 days after completion of investigational agent administration
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The mean total score on the centrally read Ottawa Bowel Preparation Quality Scale (OBPQS)		At time of colonoscopy
Secondary	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
Secondary	The mean segmental scores and the mean colonic fluid quantity score from the centrally read OBPQS		At time of colonoscopy
Secondary	The proportion of subjects achieving a score of 8 or greater on the Boston Bowel Preparation Scale (BBPS)		At time of colonoscopy
Secondary	The proportion of subjects with segmental scores of 2 or greater on the BBPS for every one of the segments		At time of colonoscopy
Secondary	The mean total score on the BBPS		At time of colonoscopy
Secondary	The Aronchick score (excellent, good, fair, poor, unsatisfactory)		At time of colonoscopy