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

NCT02910440 | Completed Phase 2

• 1 other identifier: DCL-101-201
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (28)

• Incidence of Graded Adverse Events

  1-2 days after completion of investigational agent administration

• Incidence of Graded Adverse Events

  7 days after completion of investigational agent administration

• Incidence of Serious Adverse Events

  2-6 hours after completion of investigational agent administration

• Incidence of Serious Adverse Events

  1-2 days after completion of investigational agent administration

• Incidence of Serious Adverse Events

  7 days after completion of investigational agent administration

Study Arms (2)

DCL-101

EXPERIMENTAL

Drug: DCL-101 vs Golytely

GoLytely

ACTIVE COMPARATOR

Drug: DCL-101 vs Golytely

Interventions

DCL-101 vs Golytely DRUG

DCL-101; GoLytely

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dark Canyon Laboratories, LLC: lead

Study Sites (5)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Asheville Gastroenterology

Asheville, North Carolina, 28801, United States

Location

Cumberland Research Associates LLC

Fayetteville, North Carolina, 28304, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Trial Management Associates

Wilmington, North Carolina, 28403, United States

Location

Related Publications (1)

• 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.

  PMID: 33512795 DERIVED

Study Officials

• Philip N Calvillo

  Alimentiv Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 22, 2016
• Study Start: January 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 13, 2020

Record last verified: 2020-05

Locations

US (5)