NCT00767728 is a Phase 3 clinical trial of Granulated mesalamine in Ulcerative Colitis, sponsored by Bausch Health Americas, Inc..

Who is sponsoring NCT00767728?

NCT00767728 is sponsored by Bausch Health Americas, Inc..

What drugs are being tested in NCT00767728?

Interventions in NCT00767728: Granulated mesalamine, Placebo.

What condition does NCT00767728 study?

NCT00767728 studies Ulcerative Colitis.

Is NCT00767728 still recruiting?

NCT00767728 is currently completed. Last updated 26 November 2019.

Last reviewed 2019-11-26 · How we verify

NCT00767728

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative Colitis

Completed Phase 3 Last updated 26 November 2019

What this trial tests

Phase 3 trial testing Granulated mesalamine in Ulcerative Colitis in 256 participants. Completed in 1 October 2007.

Timeline

1 December 2004

Primary endpoint
1 August 2007

1 October 2007

Quick facts

Lead sponsor	Bausch Health Americas, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	256
Start date	1 December 2004
Primary completion	1 August 2007
Estimated completion	1 October 2007
Sites	1 location across United States

Drugs / interventions tested

Granulated mesalamine — full drug profile →
Placebo

Conditions studied

Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Bausch Health Americas, Inc. — full company profile →

Who can join

18 and older, any sex, with Ulcerative Colitis. 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.

Proportion of subject who were relapse free after 6 months of treatment
Time frame: 6 months

Sponsor's own description

The purpose of this study is to compare the maintenance of mild to moderate ulcerative colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day versus placebo.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Mesalazine granules 1.5 g once-daily maintain remission in patients with ulcerative colitis who switch from other 5-ASA formulations: a pooled analysis from two randomised controlled trials.
Lichtenstein GR, Zakko S, Gordon GL, Murthy U, et al · · 2012 · cited 8× · PMID 22617015 · DOI 10.1111/j.1365-2036.2012.05142.x
Once-daily mesalamine granules for maintaining remission of ulcerative colitis: pooled analysis of efficacy, safety, and prognostic factors.
Zakko SF, Gordon GL, Murthy U, Sedghi S, et al · · 2016 · cited 7× · PMID 26861051 · DOI 10.1080/00325481.2016.1152876
Long-Term Benefit of Mesalamine Granules for Patients Who Achieved Corticosteroid-Induced Ulcerative Colitis Remission.
Lichtenstein GR, Gordon GL, Zakko S, Murthy U, et al · · 2016 · cited 5× · PMID 26563167 · DOI 10.1007/s10620-015-3866-7

Verify or expand the search:

Other recruiting trials for Ulcerative Colitis

Currently open trials in the same condition.

NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) · Phase 2 · recruiting
NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting

Other Bausch Health Americas, Inc. trials

Trials by the same sponsor.

NCT07285785 — Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea · Phase 4 · recruiting
NCT07428538 — Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH) · Phase 3 · recruiting
NCT05098028 — Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients With Sickle Cell Disease · Phase 2 · completed
NCT05027282 — Safety and Effectiveness of the CLEAR + BRILLIANT TOUCH(R) Diode Laser 1440-nm and 1927-nm Combination Wavelength Treatm · NA · completed
NCT05132231 — Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Wor · active not recruiting

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 NCT00767728 (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 Bausch Health Americas, Inc.
Last refreshed: 26 November 2019

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/NCT00767728.

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