Clinical trial

Once-daily mesalamine granules for maintenance of remission of ulcerative colitis - A 6-month placebo-controlled trial

G. R. Lichtenstein, G. L. Gordon, S. Zakko, U. Murthy, S. Sedghi, Ronald Pruitt, K. Merchant, A. Shaw, E. Bortey, W. P. Forbes

    Research output: Contribution to journalArticle

    41 Citations (Scopus)

    Abstract

    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. Methods Randomized, double-blind, placebo-controlled trial of patients (n = 209 MG, n = 96 placebo) with UC in remission [revised Sutherland Disease Activity Index (SDAI) rectal bleeding = 0, mucosal appearance <2] who took MG 1.5 g or placebo once-daily for up to 6 months. Primary efficacy endpoint: the percentage of patients who remained relapse-free at month 6/end of treatment. Relapse was defined as SDAI rectal bleeding score ≥1 and a mucosal appearance score ≥2, a UC flare, or initiation of medication to treat a UC flare. Results The percentage of relapse-free patients at month 6/end of treatment was higher with MG than placebo (78.9% vs. 58.3%, P < 0.001) in the intent-to-treat analysis. Significant differences (P ≤ 0.025) favouring MG were observed for most secondary endpoints including improvement in rectal bleeding, physician's disease activity rating, stool frequency, the SDAI at month 6/end of treatment, patients classified as a treatment success and relapse-free duration. The incidence of adverse events was similar between groups. Conclusions Once-daily mesalamine (mesalazine) was effective in maintaining remission of UC for 6 months.

    Original languageEnglish (US)
    Pages (from-to)990-999
    Number of pages10
    JournalAlimentary Pharmacology and Therapeutics
    Volume32
    Issue number8
    DOIs
    StatePublished - Oct 15 2010

    Fingerprint

    Mesalamine
    Ulcerative Colitis
    Placebos
    Maintenance
    Clinical Trials
    Recurrence
    Hemorrhage
    Therapeutics
    Double-Blind Method
    Physicians
    Incidence

    All Science Journal Classification (ASJC) codes

    • Hepatology
    • Gastroenterology
    • Pharmacology (medical)

    Cite this

    Clinical trial : Once-daily mesalamine granules for maintenance of remission of ulcerative colitis - A 6-month placebo-controlled trial. / Lichtenstein, G. R.; Gordon, G. L.; Zakko, S.; Murthy, U.; Sedghi, S.; Pruitt, Ronald; Merchant, K.; Shaw, A.; Bortey, E.; Forbes, W. P.

    In: Alimentary Pharmacology and Therapeutics, Vol. 32, No. 8, 15.10.2010, p. 990-999.

    Research output: Contribution to journalArticle

    Lichtenstein, GR, Gordon, GL, Zakko, S, Murthy, U, Sedghi, S, Pruitt, R, Merchant, K, Shaw, A, Bortey, E & Forbes, WP 2010, 'Clinical trial: Once-daily mesalamine granules for maintenance of remission of ulcerative colitis - A 6-month placebo-controlled trial', Alimentary Pharmacology and Therapeutics, vol. 32, no. 8, pp. 990-999. https://doi.org/10.1111/j.1365-2036.2010.04438.x
    Lichtenstein, G. R. ; Gordon, G. L. ; Zakko, S. ; Murthy, U. ; Sedghi, S. ; Pruitt, Ronald ; Merchant, K. ; Shaw, A. ; Bortey, E. ; Forbes, W. P. / Clinical trial : Once-daily mesalamine granules for maintenance of remission of ulcerative colitis - A 6-month placebo-controlled trial. In: Alimentary Pharmacology and Therapeutics. 2010 ; Vol. 32, No. 8. pp. 990-999.
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    abstract = "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. Methods Randomized, double-blind, placebo-controlled trial of patients (n = 209 MG, n = 96 placebo) with UC in remission [revised Sutherland Disease Activity Index (SDAI) rectal bleeding = 0, mucosal appearance <2] who took MG 1.5 g or placebo once-daily for up to 6 months. Primary efficacy endpoint: the percentage of patients who remained relapse-free at month 6/end of treatment. Relapse was defined as SDAI rectal bleeding score ≥1 and a mucosal appearance score ≥2, a UC flare, or initiation of medication to treat a UC flare. Results The percentage of relapse-free patients at month 6/end of treatment was higher with MG than placebo (78.9{\%} vs. 58.3{\%}, P < 0.001) in the intent-to-treat analysis. Significant differences (P ≤ 0.025) favouring MG were observed for most secondary endpoints including improvement in rectal bleeding, physician's disease activity rating, stool frequency, the SDAI at month 6/end of treatment, patients classified as a treatment success and relapse-free duration. The incidence of adverse events was similar between groups. Conclusions Once-daily mesalamine (mesalazine) was effective in maintaining remission of UC for 6 months.",
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    T2 - Once-daily mesalamine granules for maintenance of remission of ulcerative colitis - A 6-month placebo-controlled trial

    AU - Lichtenstein, G. R.

    AU - Gordon, G. L.

    AU - Zakko, S.

    AU - Murthy, U.

    AU - Sedghi, S.

    AU - Pruitt, Ronald

    AU - Merchant, K.

    AU - Shaw, A.

    AU - Bortey, E.

    AU - Forbes, W. P.

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    N2 - 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. Methods Randomized, double-blind, placebo-controlled trial of patients (n = 209 MG, n = 96 placebo) with UC in remission [revised Sutherland Disease Activity Index (SDAI) rectal bleeding = 0, mucosal appearance <2] who took MG 1.5 g or placebo once-daily for up to 6 months. Primary efficacy endpoint: the percentage of patients who remained relapse-free at month 6/end of treatment. Relapse was defined as SDAI rectal bleeding score ≥1 and a mucosal appearance score ≥2, a UC flare, or initiation of medication to treat a UC flare. Results The percentage of relapse-free patients at month 6/end of treatment was higher with MG than placebo (78.9% vs. 58.3%, P < 0.001) in the intent-to-treat analysis. Significant differences (P ≤ 0.025) favouring MG were observed for most secondary endpoints including improvement in rectal bleeding, physician's disease activity rating, stool frequency, the SDAI at month 6/end of treatment, patients classified as a treatment success and relapse-free duration. The incidence of adverse events was similar between groups. Conclusions Once-daily mesalamine (mesalazine) was effective in maintaining remission of UC for 6 months.

    AB - 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. Methods Randomized, double-blind, placebo-controlled trial of patients (n = 209 MG, n = 96 placebo) with UC in remission [revised Sutherland Disease Activity Index (SDAI) rectal bleeding = 0, mucosal appearance <2] who took MG 1.5 g or placebo once-daily for up to 6 months. Primary efficacy endpoint: the percentage of patients who remained relapse-free at month 6/end of treatment. Relapse was defined as SDAI rectal bleeding score ≥1 and a mucosal appearance score ≥2, a UC flare, or initiation of medication to treat a UC flare. Results The percentage of relapse-free patients at month 6/end of treatment was higher with MG than placebo (78.9% vs. 58.3%, P < 0.001) in the intent-to-treat analysis. Significant differences (P ≤ 0.025) favouring MG were observed for most secondary endpoints including improvement in rectal bleeding, physician's disease activity rating, stool frequency, the SDAI at month 6/end of treatment, patients classified as a treatment success and relapse-free duration. The incidence of adverse events was similar between groups. Conclusions Once-daily mesalamine (mesalazine) was effective in maintaining remission of UC for 6 months.

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    SN - 0269-2813

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