Bowel Preparation Before ColonoscopyPhase 2NCT02910440
A Safety and Efficacy Study of DCL-101 Compared to GoLYTELY
A Phase 2 study testing DCL-101 vs Golytely in people with Bowel Preparation Before Colonoscopy, run by Dark Canyon Laboratories, LLC at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bowel Preparation Before Colonoscopy
- What is being tested?
- DCL-101 vs Golytely
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2017to Nov 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
- Serious underlying disease that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study
- 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
- Pregnant or lactating women
- Prior enrolment in the current study and had received study treatment
- Cognitive barriers that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study
- Inability to either read or understand English
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Asheville Gastroenterology
Asheville, North Carolina, 28801
Cumberland Research Associates LLC
Fayetteville, North Carolina, 28304
Wake Research Associates
Raleigh, North Carolina, 27612
Trial Management Associates
Wilmington, North Carolina, 28403
About this study
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
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
- Being tested
- DCL-101 vs Golytely
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCL-101 vs GolytelyDrug
| Study group | Role | What they receive |
|---|---|---|
| DCL-101 | Experimental | Not described Receives: Drug: DCL-101 vs Golytely |
| GoLytely | Active comparator | Not described Receives: Drug: DCL-101 vs Golytely |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 2-6 hours after completion of investigational agent administration
Secondary outcomes (28)
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"
Measured: 1-2 days after completion of investigational agent administration
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"
Measured: 7 days after completion of investigational agent administration
Incidence of Serious Adverse Events
Scale: Events that are life-threatening, lead to hospitalization, cause permanent injury, or death
Measured: 2-6 hours after completion of investigational agent administration
Incidence of Serious Adverse Events
Scale: Events that are life-threatening, lead to hospitalization, cause permanent injury, or death
Measured: 1-2 days after completion of investigational agent administration
Incidence of Serious Adverse Events
Scale: Events that are life-threatening, lead to hospitalization, cause permanent injury, or death
Measured: 7 days after completion of investigational agent administration
Incidence of abnormal blood chemistries
Scale: Normal range, as established by study reference laboratory
Measured: 2-6 hours after completion of investigational agent administration
Incidence of abnormal blood chemistries
Scale: Normal range, as established by study reference laboratory
Measured: 1-2 days after completion of investigational agent administration
Incidence of abnormal blood chemistries
Scale: Normal range, as established by study reference laboratory
Measured: 7 days after completion of investigational agent administration
Incidence of abnormal urinalysis
Scale: Normal range, as established by study reference laboratory
Measured: 2-6 hours after completion of investigational agent administration
Incidence of abnormal urinalysis
Scale: Normal range, as established by study reference laboratory
Measured: 1-2 days after completion of investigational agent administration
Incidence of abnormal urinalysis
Scale: Normal range, as established by study reference laboratory
Measured: 7 days after completion of investigational agent administration
Incidence of clinically significant electrocardiogram (ECG) changes
Scale: Comparison with baseline ECG
Measured: 2-6 hours after completion of investigational agent administration
Incidence of clinically significant electrocardiogram (ECG) changes
Scale: Comparison with baseline ECG
Measured: 7 days after completion of investigational agent administration
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.
Measured: 2-6 hours after completion of investigational agent administration
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.
Measured: 1-2 days after completion of investigational agent administration
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.
Measured: 7 days after completion of investigational agent administration
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.
Measured: 2-6 hours after completion of investigational agent administration
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
Measured: 2-6 hours after completion of investigational agent administration
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.
Measured: 2-6 hours after completion of investigational agent administration
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
Measured: At time of colonoscopy
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.
Measured: At time of colonoscopy
The mean total score on the centrally read Ottawa Bowel Preparation Quality Scale (OBPQS)
Measured: 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
Measured: At time of colonoscopy
The mean segmental scores and the mean colonic fluid quantity score from the centrally read OBPQS
Measured: At time of colonoscopy
The proportion of subjects achieving a score of 8 or greater on the Boston Bowel Preparation Scale (BBPS)
Measured: At time of colonoscopy
The proportion of subjects with segmental scores of 2 or greater on the BBPS for every one of the segments
Measured: At time of colonoscopy
The mean total score on the BBPS
Measured: At time of colonoscopy
The Aronchick score (excellent, good, fair, poor, unsatisfactory)
Measured: At time of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startJan 2017
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bowel Preparation Before ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dark Canyon Laboratories, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip N Calvillo, Study chair, Alimentiv Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910440
- Sponsor's protocol ID
- DCL-101-201
- Status last verified
- May 2020
- First submitted
- 20 Sep 2016
- Last updated
- 13 May 2020
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02910440
- Acronym / sponsor ID
- DCL-101-201
- Conditions
- Bowel Preparation Before Colonoscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Dark Canyon Laboratories, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCL-101 | Experimental | Drug: DCL-101 vs Golytely |
| GoLytely | Active comparator | Drug: DCL-101 vs Golytely |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCL-101 vs Golytely | Drug | DCL-101, GoLytely |
Primary outcome
Incidence of Graded Adverse Events
Time frame: 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"
28 secondary outcomes
Incidence of Graded Adverse Events
Time frame: 1-2 days after completion of investigational agent administration
Incidence of Graded Adverse Events
Time frame: 7 days after completion of investigational agent administration
Incidence of Serious Adverse Events
Time frame: 2-6 hours after completion of investigational agent administration
Incidence of Serious Adverse Events
Time frame: 1-2 days after completion of investigational agent administration
Incidence of Serious Adverse Events
Time frame: 7 days after completion of investigational agent administration
Incidence of abnormal blood chemistries
Time frame: 2-6 hours after completion of investigational agent administration
Incidence of abnormal blood chemistries
Time frame: 1-2 days after completion of investigational agent administration
Incidence of abnormal blood chemistries
Time frame: 7 days after completion of investigational agent administration
Incidence of abnormal urinalysis
Time frame: 2-6 hours after completion of investigational agent administration
Incidence of abnormal urinalysis
Time frame: 1-2 days after completion of investigational agent administration
Incidence of abnormal urinalysis
Time frame: 7 days after completion of investigational agent administration
Incidence of clinically significant electrocardiogram (ECG) changes
Time frame: 2-6 hours after completion of investigational agent administration
Incidence of clinically significant electrocardiogram (ECG) changes
Time frame: 7 days after completion of investigational agent administration
Incidence of orthostatic hypotension
Time frame: 2-6 hours after completion of investigational agent administration
Incidence of orthostatic hypotension
Time frame: 1-2 days after completion of investigational agent administration
Incidence of orthostatic hypotension
Time frame: 7 days after completion of investigational agent administration
Between group difference in the aggregate tolerability score (ATS) of the Lawrance Colonoscopy Preparation Patient Tolerability Questionnaire
Time frame: 2-6 hours after completion of investigational agent administration
Between group difference in score in individual aspects of the Lawrance Colonoscopy Preparation Patient Tolerability Questionnaire
Time frame: 2-6 hours after completion of investigational agent administration
Between group difference in the Symptom Score of the Mayo Clinic Bowel Prep Tolerability Questionnaire
Time frame: 2-6 hours after completion of investigational agent administration
Proportion of subjects compliant with 90% of the study treatment regimen
Time frame: At time of colonoscopy
Proportion of subjects compliant with 100% of the study treatment regimen
Time frame: At time of colonoscopy
The mean total score on the centrally read Ottawa Bowel Preparation Quality Scale (OBPQS)
Time frame: 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
Time frame: At time of colonoscopy
The mean segmental scores and the mean colonic fluid quantity score from the centrally read OBPQS
Time frame: At time of colonoscopy
The proportion of subjects achieving a score of 8 or greater on the Boston Bowel Preparation Scale (BBPS)
Time frame: At time of colonoscopy
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
The mean total score on the BBPS
Time frame: At time of colonoscopy
The Aronchick score (excellent, good, fair, poor, unsatisfactory)
Time frame: At time of colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Derived from this study: PubMed 33512795Bachwich 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.
Related trials for Bowel Preparation Before Colonoscopy
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
RecruitingPhase 3
A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy
Bowel Cleansing Prior to Clinical Procedures
Recruiting
Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation
Bowel Preparation Before Colonoscopy
Active, not recruiting
The Efficacy of AI-Driven Feces Identification for Bowel Preparation Prior to Colonoscopy
AI App Improves Bowel Preparation Quality for Colonoscopy
Not yet recruitingObservational study
The Effect of pH Value of Water Consumed During Bowel Preparation Before Colonoscopy on Colon Cleansing
Colonoscopy, Bowel Cleansing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip N Calvillo study chair
Alimentiv Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DCL-101 vs Golytely in people with Bowel Preparation Before Colonoscopy, run by Dark Canyon Laboratories, LLC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Graded Adverse Events (time frame: 2-6 hours after completion of investigational agent administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02910440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.