NCT00712543 is a Phase 4 clinical trial of lactulose (Kristalose®) in Constipation, sponsored by Cumberland Pharmaceuticals.

Who is sponsoring NCT00712543?

NCT00712543 is sponsored by Cumberland Pharmaceuticals.

What drugs are being tested in NCT00712543?

Interventions in NCT00712543: lactulose (Kristalose®), liquid lactulose.

What condition does NCT00712543 study?

NCT00712543 studies Constipation.

Is NCT00712543 still recruiting?

NCT00712543 is currently completed. Last updated 19 August 2011.

Are results published for NCT00712543?

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

Last reviewed 2011-08-19 · How we verify

NCT00712543

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

A Preference Study Comparing Kristalose® and Liquid Lactulose in the Treatment of Constipation

Completed Phase 4 Results posted Last updated 19 August 2011

What this trial tests

Phase 4 trial testing lactulose (Kristalose®) in Constipation in 50 participants. Completed in 1 September 2009.

Timeline

1 June 2009

Primary endpoint
1 September 2009

1 September 2009

Quick facts

Lead sponsor	Cumberland Pharmaceuticals
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 June 2009
Primary completion	1 September 2009
Estimated completion	1 September 2009
Sites	3 locations across United States

Drugs / interventions tested

lactulose (Kristalose®) — full drug profile →
liquid lactulose — full drug profile →

Conditions studied

Constipation — all drugs for Constipation →

Sponsor

Cumberland Pharmaceuticals — full company profile →

Who can join

Adults 18 to 70, any sex, with Constipation. 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.

Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
Time frame: 14 days

Sponsor's own description

This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Comparison of preference and safety of powder and liquid lactulose in adult patients with chronic constipation.
Barish CF, Voss B, Kaelin B. · · 2010 · cited 3× · PMID 21694860 · DOI 10.2147/ceg.s13568

Verify or expand the search:

Other recruiting trials for Constipation

Currently open trials in the same condition.

NCT07462481 — Probiotic Improve Constipation · NA · recruiting
NCT07466914 — Constipation in Children With Cerebral Palsy · active not recruiting
NCT07215351 — Impact of the Inno Cleanse Dietary Supplement on Gut Health and Associated Variables in Healthy Men and Women · NA · recruiting
NCT07135362 — The Efficacy Evaluation of TCI604 Probiotic on Intestinal Function Improvement · NA · recruiting
NCT07091084 — A Study of Herbal Supplements in Cancer Survivors With Constipation · 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 NCT00712543 (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 Cumberland Pharmaceuticals
Last refreshed: 19 August 2011

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/NCT00712543.

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