Last reviewed · How we verify
NCT02910440
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
Phase 2 trial testing DCL-101 vs Golytely in Bowel Preparation Before Colonoscopy in 46 participants. Completed in 1 November 2017.
1 November 2017
Quick facts
| Lead sponsor | Dark Canyon Laboratories, LLC |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 1 January 2017 |
| Primary completion | 1 November 2017 |
| Estimated completion | 1 November 2017 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- DCL-101 vs Golytely — full drug profile →
Conditions studied
- Bowel Preparation Before Colonoscopy — all drugs for Bowel Preparation Before Colonoscopy →
Sponsor
Dark Canyon Laboratories, LLC — full company profile →
Who can join
Adults 18 to 75, any sex, with Bowel Preparation Before Colonoscopy. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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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"
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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A Phase 2 Randomized Trial of DCL-101, a Novel Pill-Based Colonoscopy Prep, vs 4L Polyethylene Glycol-Electrolyte Solution.
Bachwich DR, Lewis JD, Kowal VO, Jacobson BC, et al · · 2020 · PMID 33512795 · DOI 10.14309/ctg.0000000000000264
Verify or expand the search:
- PubMed search for NCT02910440
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Bowel Preparation Before Colonoscopy
Currently open trials in the same condition.
- NCT06794112 — Optimal Bowel Preparation in Geriatric Patients With a Instructional Animation Video Before Colonoscopy · NA · recruiting
- NCT06675227 — Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02910440 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dark Canyon Laboratories, LLC
- Last refreshed: 11 May 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02910440.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing