ASACOL HD SUMMARY
Each Asacol HD delayed-release tablet for oral administration contains 800 mg of mesalamine, an anti-inflammatory drug. Asacol HD delayed-release tablets have an outer protective coat consisting of a combination of acrylic based resins, Eudragit S (methacrylic acid copolymer B, NF) and Eudragit L (methacrylic acid copolymer A, NF). The inner coat consists of an acrylic based resin, Eudragit S, which dissolves at pH 7 or greater, releasing mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon.
Asacol HD is indicated for the treatment of moderately active ulcerative colitis. Safety and effectiveness of Asacol HD beyond 6 weeks has not been established.
Published Studies Related to Asacol HD (Mesalamine)
Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease. [2011.02]
BACKGROUND & AIMS: Comparative data on budesonide vs mesalamine for the treatment of mild-to-moderately active Crohn's disease (CD) are sparse. We assessed the efficacy and safety of each therapy in patients with mildly to moderately active CD... CONCLUSIONS: Budesonide (9 mg/day) was numerically, but not statistically, more effective than Eudragit-L-coated mesalamine (4.5 g/day) in patients with mildly to moderately active CD. Budesonide (9 mg/day), administered once daily, was as effective as the standard (3 times daily) regimen. Copyright (c) 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.
A multicenter, randomized study to evaluate the efficacy and safety of mesalamine suppositories 1 g at bedtime and 500 mg Twice daily in patients with active mild-to-moderate ulcerative proctitis. [2011.02]
BACKGROUND: Ulcerative proctitis (UP) is a prevalent condition associated with increased morbidity and mortality. Topical mesalamine (5-aminosalicylic acid [5-ASA]) inhibits inflammatory processes in UP... CONCLUSIONS: Mesalamine 500-mg BID and 1-g QHS suppositories are safe and effective for patients with UP. Most patients reported significant improvement within 3 weeks and UP remission and reduced disease extension after 6 weeks of treatment. Validity of QHS administration was confirmed.
Clinical trial: a novel high-dose 1 g mesalamine suppository (Salofalk) once daily is as efficacious as a 500-mg suppository thrice daily in active ulcerative proctitis. [2010.11]
BACKGROUND: Mesalamine suppositories are first-line therapy in active ulcerative proctitis; the standard regime still recommends multiple doses per day. The primary objective of this study was to show the noninferiority of once-daily administration of a novel 1 g mesalamine suppository versus thrice-daily administration of the 0.5 g mesalamine suppository... CONCLUSIONS: In active ulcerative proctitis the once-daily administration of a 1 g mesalamine suppository is as effective and safe, yet considerably more convenient, than the standard thrice-daily administration of a 0.5 g mesalamine suppository.
Clinical trial: once-daily mesalamine granules for maintenance of remission of ulcerative colitis - a 6-month placebo-controlled trial. [2010.10]
BACKGROUND: Ulcerative colitis (UC) is a chronic relapsing and remitting idiopathic inflammatory bowel disorder. AIM: To evaluate once-daily mesalamine (mesalazine) granules (MG) for maintenance of remission of UC... CONCLUSIONS: Once-daily mesalamine (mesalazine) was effective in maintaining remission of UC for 6 months. (c) 2010 Salix Pharmaceuticals.
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.
Clinical Trials Related to Asacol HD (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.
Sulfamethoxazole Drug Interaction Study With MMXï¿½ Mesalazine/Mesalamine [Recruiting]
This is a drug interaction study evaluating the pharmacokinetic profiles of Sulfamethoxazole
administered alone & in combination with MMX Mesalazine/mesalamine.
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
Curcumin + Aminosalicylic Acid (5ASA) Versus 5ASA Alone in the Treatment of Mild to Moderate Ulcerative Colitis [Recruiting]
Ulcerative colitis (UC) is a chronic inflammatory disease resulting in increased morbidity
in patients. The current standard treatment for mild to moderate UC (MTMUC) includes
5-aminosalicylic compounds (5ASA) such as olsalazine and mesalamine, yet some patients
continue to experience disease symptoms and flare-ups. These patients require higher
dosages of 5ASA medications and in many cases escalate to steroid and/or immunosuppressant
therapy which comprises higher risk of hazardous side effects.
Curcumin, an active ingredient of the Indian herb Rhizoma Curcuma Longa, has been
extensively studied in the context of inflammatory diseases. In humans, a controlled study
using curcumin as an adjusted therapy to 5ASA medication has shown it to be superior to
placebo in maintaining remission in MTMUC patients . A small, preliminary open label study
has also shown efficacy in reducing disease symptoms and inflammatory markers in this group
of patients .
This data provides bases for investigating an integrative approach to optimize the current
standard treatment in MTMUC patients. We speculate that using a combined therapy of 5ASA
medication and curcumin could benefit this subgroup of patients and reduce morbidity and
perhaps need for escalating pharmacological intervention.
The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study [Recruiting]
The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in
patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will
evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma
cytokines before and after treatment with Lialda.
This study will test long acting mesalamine in the management of PI-IBS. It has the
potential to improve QOL and perhaps gastrointestinal symptoms, in patients with PI-IBS.
The results of this study, if positive, will provide preliminary data for a large scale
This study will also provide information about plasma cytokines in patients with PI-IBS and
whether improvement in symptoms correlates with improvement in plasma cytokines.