Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    dark canyon
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02910440
Recruitment Status : Active, not recruiting
First Posted : September 22, 2016
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Dark Canyon Laboratories, LLC

Brief Summary:
The primary objective of this study is to compare the efficacy of DCL-101 to GoLYTELY in preparing the large bowel for colonoscopy. Additional secondary objectives will compare the safety of DCL-101 to GoLYTELY in preparing the large bowel for colonoscopy and compare the tolerability of DCL-101 to GoLYTELY in preparing the large bowel for colonoscopy.

Condition or disease Intervention/treatment Phase
Bowel Preparation Before Colonoscopy Drug: DCL-101 vs Golytely Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 357 participants
Primary Purpose: Treatment
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
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: GoLytely

Arm Intervention/treatment
Experimental: DCL-101 Drug: DCL-101 vs Golytely
Active Comparator: GoLytely Drug: DCL-101 vs Golytely



Primary Outcome Measures :
  1. Overall bowel cleansing success rate, comparing DCL-101 to GoLYTELY, using the centrally read Ottawa Bowel Preparation Quality Score (OBPQS) with success equal to a score of 4 or less (good or excellent). [ Time Frame: At time of colonoscopy ]

Secondary Outcome Measures :
  1. The mean total score on the centrally read OBPQS [ Time Frame: At time of colonoscopy ]
  2. 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 ]
  3. The mean segmental scores and the mean colonic fluid quantity score from the centrally read OBPQS [ Time Frame: At time of colonoscopy ]
  4. The proportion of subjects achieving a score of 8 or greater on the Boston Bowel Preparation Scale (BBPS) [ Time Frame: At time of colonoscopy ]
  5. 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 ]
  6. The mean total score on the BBPS [ Time Frame: At time of colonoscopy ]
  7. The Aronchick score (excellent, good, fair, poor, unsatisfactory) [ Time Frame: At time of colonoscopy ]
  8. Between group difference in the aggregate tolerability score (ATS) of the Lawrance Colonoscopy Preparation Patient Tolerability Questionnaire [ Time Frame: At time of colonoscopy ]
  9. Between group difference in score in individual aspects of the Lawrance Colonoscopy Preparation Patient Tolerability Questionnaire [ Time Frame: At time of colonoscopy ]
  10. Between group difference in the aggregate score of the Mayo Clinic Bowel Prep Tolerability Questionnaire [ Time Frame: At time of colonoscopy ]
  11. Proportion of subjects compliant with 90% of the study treatment regimen (a minimum of 3600 mL of PEG solution or 212 g of powder and 43 capsules, as applicable) [ Time Frame: At time of colonoscopy ]
  12. Proportion of subjects compliant with 100% of the study treatment regimen (4000 mL of PEG solution and 48 capsules, as applicable. [ Time Frame: At time of colonoscopy ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910440


Locations
Layout table for location information
United States, California
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
United States, North Carolina
Asheville Gastroenterology
Asheville, North Carolina, United States, 28801
Cumberland Research Associates LLC
Fayetteville, North Carolina, United States, 28304
Wake Research Associates
Raleigh, North Carolina, United States, 27612
Trial Management Associates
Wilmington, North Carolina, United States, 28403
Sponsors and Collaborators
Dark Canyon Laboratories, LLC
Investigators
Layout table for investigator information
Study Chair: Philip N Calvillo Robarts Clinical Trials Inc.

Layout table for additonal information
Responsible Party: Dark Canyon Laboratories, LLC
ClinicalTrials.gov Identifier: NCT02910440     History of Changes
Other Study ID Numbers: DCL-101-201
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017