Who is sponsoring NCT02123017?

NCT02123017 is sponsored by Cumberland Pharmaceuticals.

What drugs are being tested in NCT02123017?

Interventions in NCT02123017: 90 grams of Crystalline Lactulose, 135 grams of Crystalline Lactulose, 180 grams of Crystalline Lactulose.

What condition does NCT02123017 study?

NCT02123017 studies Colonoscopy Preparation.

Is NCT02123017 still recruiting?

NCT02123017 is currently completed. Last updated 27 January 2016.

Are results published for NCT02123017?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2016-01-27 · How we verify

NCT02123017

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Observer-blinded, Dose-finding Study to Investigate the Safety, Efficacy, and Patient Preference of Lactulose for Oral Solution With Bisacodyl for Cleansing of the Colon as a Preparation for Colonoscopy in Adults

Completed Phase 2 Results posted Last updated 27 January 2016

What this trial tests

Phase 2 trial testing 90 grams of Crystalline Lactulose in Colonoscopy Preparation in 32 participants. Completed in 1 August 2014.

Timeline

1 April 2014

Primary endpoint
1 August 2014

1 August 2014

Quick facts

Lead sponsor	Cumberland Pharmaceuticals
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	single
Primary purpose	treatment
Enrollment	32
Start date	1 April 2014
Primary completion	1 August 2014
Estimated completion	1 August 2014
Sites	1 location across United States

Drugs / interventions tested

90 grams of Crystalline Lactulose — full drug profile →
135 grams of Crystalline Lactulose — full drug profile →
180 grams of Crystalline Lactulose — full drug profile →

Conditions studied

Colonoscopy Preparation — all drugs for Colonoscopy Preparation →

Sponsor

Cumberland Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Colonoscopy Preparation. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy.
Time frame: 10-14 hours post last consumption
Efficacy assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Preparation Scale (BBPS). 9 is the maximum score, representing an fully cleansed colon; 0 is the minimal score, representing a colon with no cleaning.

Sponsor's own description

The purpose of the study is to evaluate the efficacy and safety of bisacodyl combined with escalating doses of lactulose to be used as a preparation for colonoscopy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Colonoscopy Preparation

Currently open trials in the same condition.

NCT07328880 — 4-L Split-dose Polyethylene Glycol and Bisacodyl and Docusate Sodium Regimen Versus 2-L Split-dose Polyethylene Glycol P · NA · recruiting

Other Cumberland Pharmaceuticals trials

Trials by the same sponsor.

NCT03340675 — Oral Ifetroban in Subjects With Duchenne Muscular Dystrophy · Phase 2 · completed
NCT03611010 — Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients · Phase 2 · completed
NCT02583399 — Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients · Phase 4 · completed
NCT03028350 — Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD) · Phase 2 · completed
NCT02802228 — Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02123017 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cumberland Pharmaceuticals
Last refreshed: 27 January 2016

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/NCT02123017.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing