Bowel Preparation Before Colonoscopy
Conditions
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.
Interventions
DRUGDCL-101 vs Golytely
Sponsors
Dark Canyon Laboratories, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Graded Adverse Events | 2-6 hours after completion of investigational agent administration | Scale: Common Terminology Criteria for Adverse Events, a 5-point scale with Grade 1 equal to mild and Grade 5 equal to death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Serious Adverse Events | 2-6 hours after completion of investigational agent administration | Scale: Events that are life-threatening, lead to hospitalization, cause permanent injury, or death |
| Incidence of Graded Adverse Events | 1-2 days after completion of investigational agent administration | Scale: Common Terminology Criteria for Adverse Events, a 5-point scale with Grade 1 equal to mild and Grade 5 equal to death |
| Incidence of abnormal blood chemistries | 2-6 hours after completion of investigational agent administration | Scale: Normal range, as established by study reference laboratory |
| Incidence of abnormal urinalysis | 2-6 hours after completion of investigational agent administration | Scale: Normal range, as established by study reference laboratory |
| Incidence of clinically significant electrocardiogram (ECG) changes | 2-6 hours after completion of investigational agent administration | Scale: Comparison with baseline ECG |
| Incidence of orthostatic hypotension | 2-6 hours after completion of investigational agent administration | 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. |
| Between group difference in the aggregate tolerability score (ATS) of the Lawrance Colonoscopy Preparation Patient Tolerability Questionnaire | 2-6 hours after completion of investigational agent administration | 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. |
| Between group difference in score in individual aspects of the Lawrance Colonoscopy Preparation Patient Tolerability Questionnaire | 2-6 hours after completion of investigational agent administration | Nine symptoms during bowel preparation on a 5-point Likert scale by patient |
| The Aronchick score (excellent, good, fair, poor, unsatisfactory) | At time of colonoscopy | — |
| Proportion of subjects compliant with 90% of the study treatment regimen | At time of colonoscopy | Consumption of a minimum of 90% of GoLYTELY solution or 90% of DCL-101 kit, as applicable |
| Proportion of subjects compliant with 100% of the study treatment regimen | At time of colonoscopy | Consumption of 100% of GoLYTELY solution or 100% of DCL-101 kit, as applicable. |
| The mean total score on the centrally read Ottawa Bowel Preparation Quality Scale (OBPQS) | At time of colonoscopy | — |
| 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 | — |
| The mean segmental scores and the mean colonic fluid quantity score from the centrally read OBPQS | At time of colonoscopy | — |
| The proportion of subjects achieving a score of 8 or greater on the Boston Bowel Preparation Scale (BBPS) | At time of colonoscopy | — |
| The proportion of subjects with segmental scores of 2 or greater on the BBPS for every one of the segments | At time of colonoscopy | — |
| The mean total score on the BBPS | At time of colonoscopy | — |
| Between group difference in the Symptom Score of the Mayo Clinic Bowel Prep Tolerability Questionnaire | 2-6 hours after completion of investigational agent administration | 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. |
Countries
United States
Outcome results
None listed