NCT01607060 is a Phase 3 clinical trial of Lactulone in Constipation, sponsored by Federal University of São Paulo.

Who is sponsoring NCT01607060?

NCT01607060 is sponsored by Federal University of São Paulo.

What drugs are being tested in NCT01607060?

Interventions in NCT01607060: Lactulone.

What condition does NCT01607060 study?

NCT01607060 studies Constipation.

Is NCT01607060 still recruiting?

NCT01607060 is currently completed. Last updated 5 January 2015.

Last reviewed 2015-01-05 · How we verify

NCT01607060

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

Impact of Laxative Therapy With Lactulose in the Evolution of Organ Dysfunction in Critically Ill Patients.

Completed Phase 3 Last updated 5 January 2015

What this trial tests

Phase 3 trial testing Lactulone in Constipation in 88 participants. Completed.

Timeline

1 September 2008

Primary endpoint
1 April 2012

Quick facts

Lead sponsor	Federal University of São Paulo
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	88
Start date	1 September 2008
Primary completion	1 April 2012
Sites	1 location across Brazil

Drugs / interventions tested

Lactulone — full drug profile →

Conditions studied

Constipation — all drugs for Constipation →

Sponsor

Federal University of São Paulo

Who can join

18 and older, 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.

change in SOFA score
Time frame: At the moment of inclusion and 14 days latter
Will evaluate the change in SOFA score between the time of enrollment and 14 days after enrollment, or discharge, or death if it occurs before that date.

Sponsor's own description

MAIN FEATURES OF THE STUDY: therapeutic intervention. Constipation is a frequent complication in critical ill patients. The disaccharide lactulose has a laxative osmotic activity. Given the scant evidence and the potential risk associated with constipation in seriously ill patients, this study aims to assess the impact of laxative therapy in the prognosis of critically ill patients. Study hypothesis: Constipation is part of the clinical spectrum of intestinal dysfunction and if treated can result in improved prognosis for critically ill patients.

Publications & conference data

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

Daily laxative therapy reduces organ dysfunction in mechanically ventilated patients: a phase II randomized controlled trial.
de Azevedo RP, Freitas FG, Ferreira EM, Pontes de Azevedo LC, et al · · 2015 · cited 21× · PMID 26373705 · DOI 10.1186/s13054-015-1047-x

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 Federal University of São Paulo trials

Trials by the same sponsor.

NCT07376811 — Effect Of Sleeping Posture Guidance On Sleep Quality In Patients With Rotator Cuff Syndrome · NA · not yet recruiting
NCT06805656 — Multi Interventional Approaches to Mitigate HIV Reservoirs Aiming the Sustained HIV Remission Without Antiretrovirals · Phase 2 · not yet recruiting
NCT06970964 — Fermented Milk Drink With Lacticaseibacillus Paracasei Strain Shirota Helps Triathletes With Cold-Like Symptoms Before a · NA · completed
NCT06905860 — Intra-articular Infiltration of Platelet-Rich Fibrin vs Corticosteroid in Mild to Moderate Knee Osteoarthritis · Phase 4 · not yet recruiting
NCT06829992 — Effects of Applying Kinesio Tapping on Primary Dysmenorrhea in Football Players · NA · 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 NCT01607060 (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 Federal University of São Paulo
Last refreshed: 5 January 2015

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/NCT01607060.

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