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CompletedNCT02910440Updated May 13, 2020

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

A Phase 2 interventional study of DCL-101 vs Golytely in Bowel Preparation Before Colonoscopy, sponsored by Dark Canyon Laboratories, LLC. Completed at 5 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-13.

Sponsored by Dark Canyon Laboratories, LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • Bowel Preparation Before Colonoscopy
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In context

Lead sponsor

This is the only study on the registry with Dark Canyon Laboratories, LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    DCL-101

    Drug: DCL-101 vs Golytely

  • Active comparator
    GoLytely

    Drug: DCL-101 vs Golytely

Interventions

  • DrugDCL-101 vs Golytely
06

What researchers measure

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"

    Time frame: 2-6 hours after completion of investigational agent administration

Secondary 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"

    Time frame: 1-2 days after completion of investigational agent administration

  2. 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"

    Time frame: 7 days after completion of investigational agent administration

  3. Incidence of Serious Adverse Events

    Scale: Events that are life-threatening, lead to hospitalization, cause permanent injury, or death

    Time frame: 2-6 hours after completion of investigational agent administration

  4. Incidence of Serious Adverse Events

    Scale: Events that are life-threatening, lead to hospitalization, cause permanent injury, or death

    Time frame: 1-2 days after completion of investigational agent administration

  5. Incidence of Serious Adverse Events

    Scale: Events that are life-threatening, lead to hospitalization, cause permanent injury, or death

    Time frame: 7 days after completion of investigational agent administration

  6. Incidence of abnormal blood chemistries

    Scale: Normal range, as established by study reference laboratory

    Time frame: 2-6 hours after completion of investigational agent administration

  7. Incidence of abnormal blood chemistries

    Scale: Normal range, as established by study reference laboratory

    Time frame: 1-2 days after completion of investigational agent administration

  8. Incidence of abnormal blood chemistries

    Scale: Normal range, as established by study reference laboratory

    Time frame: 7 days after completion of investigational agent administration

  9. Incidence of abnormal urinalysis

    Scale: Normal range, as established by study reference laboratory

    Time frame: 2-6 hours after completion of investigational agent administration

  10. Incidence of abnormal urinalysis

    Scale: Normal range, as established by study reference laboratory

    Time frame: 1-2 days after completion of investigational agent administration

  11. Incidence of abnormal urinalysis

    Scale: Normal range, as established by study reference laboratory

    Time frame: 7 days after completion of investigational agent administration

  12. Incidence of clinically significant electrocardiogram (ECG) changes

    Scale: Comparison with baseline ECG

    Time frame: 2-6 hours after completion of investigational agent administration

  13. Incidence of clinically significant electrocardiogram (ECG) changes

    Scale: Comparison with baseline ECG

    Time frame: 7 days after completion of investigational agent administration

  14. 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.

    Time frame: 2-6 hours after completion of investigational agent administration

  15. 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.

    Time frame: 1-2 days after completion of investigational agent administration

  16. 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.

    Time frame: 7 days after completion of investigational agent administration

  17. 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.

    Time frame: 2-6 hours after completion of investigational agent administration

  18. 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

    Time frame: 2-6 hours after completion of investigational agent administration

  19. 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.

    Time frame: 2-6 hours after completion of investigational agent administration

  20. 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

    Time frame: At time of colonoscopy

  21. 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.

    Time frame: At time of colonoscopy

  22. The mean total score on the centrally read Ottawa Bowel Preparation Quality Scale (OBPQS)

    Time frame: At time of colonoscopy

  23. 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

  24. The mean segmental scores and the mean colonic fluid quantity score from the centrally read OBPQS

    Time frame: At time of colonoscopy

  25. The proportion of subjects achieving a score of 8 or greater on the Boston Bowel Preparation Scale (BBPS)

    Time frame: At time of colonoscopy

  26. 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

  27. The mean total score on the BBPS

    Time frame: At time of colonoscopy

  28. The Aronchick score (excellent, good, fair, poor, unsatisfactory)

    Time frame: At time of colonoscopy

07

Study locations

5 sites
  • Anaheim Clinical Trials, LLC
    Anaheim, California 92801, United States
  • Asheville Gastroenterology
    Asheville, North Carolina 28801, United States
  • Cumberland Research Associates LLC
    Fayetteville, North Carolina 28304, United States
  • Wake Research Associates
    Raleigh, North Carolina 27612, United States
  • Trial Management Associates
    Wilmington, North Carolina 28403, United States
08

References and documents

Publications

  • 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. PubMed 33512795 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02910440
Lead sponsor
Dark Canyon Laboratories, LLC
Responsible party
Sponsor
First posted
Sep 22, 2016
Start date
Jan 2017
Primary completion
Nov 2017
Completion
Nov 2017
Last update
May 13, 2020

Study contacts

Philip N Calvillo
study chair · Alimentiv Inc.
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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