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

NCT ID: NCT02910440

Last Updated: 2020-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-11-30

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.

Conditions

Bowel Preparation Before Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DCL-101

Group Type: EXPERIMENTAL

DCL-101 vs Golytely

Intervention Type: DRUG

GoLytely

Group Type: ACTIVE_COMPARATOR

DCL-101 vs Golytely

Intervention Type: DRUG

Interventions

DCL-101 vs Golytely

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dark Canyon Laboratories, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip N Calvillo

Role: STUDY_CHAIR

Alimentiv Inc.

Locations

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, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33512795 (View on PubMed)

Other Identifiers

DCL-101-201

Identifier Type: -

Identifier Source: org_study_id