NEWS HIGHLIGHTS
Published Studies Related to Lialda (Mesalamine)
Once-daily dosing of delayed-release oral mesalamine (400-mg tablet) is as effective as twice-daily dosing for maintenance of remission of ulcerative colitis. [2010.04]
BACKGROUND & AIMS: The practice of dosing mesalamines in divided doses for the treatment of ulcerative colitis (UC) began with sulfasalazine and was driven by sulfapyridine toxicity. This convention and the assumption that dosing multiple times a day is necessary to treat UC had not been challenged until recently. This study was conducted to determine the efficacy and safety of once-daily dosing of delayed-release mesalamine (Asacol 400-mg tablets) compared with twice-daily dosing for maintaining remission in UC patients... CONCLUSIONS: Once-daily dosing of delayed-release mesalamine at doses of 1.6-2.4 g/day was shown to be as effective as twice-daily dosing for maintenance of clinical remission in patients with UC. 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.
Survival of the probiotic Escherichia coli Nissle 1917 (EcN) in the gastrointestinal tract given in combination with oral mesalamine to healthy volunteers. [2010.02]
BACKGROUND: Mesalamine and the probiotic E. coli Nissle 1917 (EcN) are both effective agents for the treatment of ulcerative colitis. A combined therapy may have more than additive efficacy. However, mesalamine may have antimicrobial effects on EcN... CONCLUSIONS: The combination of EcN and mesalamine has no significant effect on the survival of EcN in healthy volunteers.
Direct comparison of two different mesalamine formulations for the induction of
remission in patients with ulcerative colitis: a double-blind, randomized study. [2010]
formulations for the induction of remission in patients with UC... CONCLUSIONS: Higher dose of the pH-dependent release formulation was more
Delayed-release oral mesalamine 4.8 g/day (800-mg tablet) is effective for patients with moderately active ulcerative colitis. [2009.12]
BACKGROUND AND AIMS: It is not clear what induction dose of mesalamine is optimal for treating patients with mildly and moderately active ulcerative colitis (UC). This study was conducted to determine the efficacy and safety of mesalamine 4.8 g/day compared with 2.4 g/day for the treatment of moderately active UC... CONCLUSIONS: Delayed-release mesalamine 4.8 g/day (800-mg tablet) is efficacious and well-tolerated in patients with moderately active UC.
Mesalamine once daily is more effective than twice daily in patients with quiescent ulcerative colitis. [2009.07]
BACKGROUND & AIMS: Oral mesalamine (5-aminosalicylate) is the current standard of care for mild-to-moderate ulcerative colitis. We investigated the efficacy and safety of once daily administration of prolonged-release mesalamine granules in maintenance of remission in patients with quiescent ulcerative colitis, compared with the well established twice daily dosing regimen... CONCLUSIONS: Patients with ulcerative colitis given prolonged-release oral mesalamine 2 g once daily had better remission rates, acceptability, and self-reported adherence to therapy compared with patients given oral mesalamine 1 g twice daily.
Clinical Trials Related to Lialda (Mesalamine)
A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s Disease [Completed]
The primary objective of the clinical trial is the assessment of the acceptability of the new
Pentasa formulation - PentasaR Sachets in comparison with the reference PentasaR tablets 500
mg in children with Crohn's disease. After the screening period (which includes medical
history, physical examination, basic haematology, serum chemistry , urine analysis and stool
microbiology , PCD Activity Index )patients will receive (visit I) Pentasa sachets 1g or
Pentasa tablets 500mg for next 4 weeks according to the randomisation scheme in common dose
2× 1 g of PentasaR Sachets 1 g or PentasaR tablets 500 mg. The formulation of Pentasa will be
switched at Visit 2, patients will receive the medication for next 4 weeks. Patients will
record the acceptability of the both forms of the medication.
In 6 patients from each group (selected by the randomization), stool and urine will be taken
to assess concentrations of mesalazine and N-acetylmesalazine during Visit 2 and Visit 3.
Adverse events will be recorded during the whole course of the treatment period.
Sulfamethoxazole Drug Interaction Study With MMX� Mesalazine/Mesalamine [Recruiting]
This is a drug interaction study evaluating the pharmacokinetic profiles of Sulfamethoxazole
administered alone & in combination with MMX Mesalazine/mesalamine.
Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis [Recruiting]
The purpose of this study is to determine whether low dose Asacol® (27 mg/kg - 71 mg/kg) and high dose Asacol® (53 mg/kg - 118 mg/kg) are safe and effective when dosed as 400 mg
delayed-release tablets given twice daily for 26 weeks to children and adolescents for the
maintenance of remission of ulcerative colitis.
Canadian Active & Maintenance Modified Pentasa Study [Recruiting]
The purpose of this study is to demonstrate that the new modified oral extended-release
Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg
tablet in active mild to moderate Ulcerative Colitis and also in maintenance of quiescent
disease.
Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis [Recruiting]
This study was designed to evaluate if subjects who achieve complete remission after 8 weeks
of acute therapy with MMX mesalamine/mesalazine 4. 8g/day given QD have better long-term
outcomes and remain in remission longer compared with subjects who demonstrate only partial
remission after acute therapy with MMX mesalamine/mesalazine 4. 8g/day given QD. Therefore,
subjects who achieve either complete or partial remission will enter into a 12-month
maintenance phase, during which they will receive MMX mesalamine/mesalazine 2. 4g/day given
QD. Remission status for the 2 groups will be evaluated and compared at the end of this
12-month maintenance period. The data obtained from this study will provide scientifically
meaningful information to demonstrate that achieving complete remission (clinical and
endoscopic remission) is important for a better long-term prognosis, or that the current
paradigm of symptomatic treatment is appropriate.
Reports of Suspected Lialda (Mesalamine) Side Effects
Inappropriate Schedule of Drug Administration (12),
Diarrhoea (12),
Colitis Ulcerative (11),
OFF Label USE (9),
Abdominal Pain (6),
Drug Ineffective (6),
Condition Aggravated (6),
Colitis (6),
Weight Decreased (5),
Pyrexia (5), more >>
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