Safety and efficacy of a new 3.3g b.i.d. tablet formulation in patients with mild-to-moderately-active ulcerative colitis

A multicenter, randomized, double-blind, placebo-controlled study

Ellen J. Scherl, Ronald Pruitt, Glenn L. Gordon, Mark Lamet, Audrey Shaw, Shirley Huang, Shadreck Mareya, William P. Forbes

    Research output: Contribution to journalArticle

    25 Citations (Scopus)

    Abstract

    OBJECTIVES:To evaluate the safety and efficacy of a new twice-daily balsalazide disodium 1.1g tablet dosing regimen (6.6gday, three tablets twice daily) for the treatment of mild-to-moderately-active ulcerative colitis (UC).METHODS:In a double-blind, multicenter study patients with symptoms of acute UC and a baseline Modified Mayo Disease Activity Index (MMDAI) score between 6 and 10, inclusive, with a subscale rating of 2 for both rectal bleeding and mucosal appearance were randomized to receive 3.3g of balsalazide or placebo tablets twice daily for 8 weeks. The primary end point was the proportion of patients achieving clinical improvement (3 point improvement in MMDAI) and improvement in rectal bleeding (1 point improvement) at 8 weeks. Safety assessments were conducted from baseline through 2-weeks post-treatment.RESULTS:A total of 249 patients (166 balsalazide, 83 placebo) received at least 1 dose of study medication. The mean MMDAI score at baseline was 7.9; 62 of patients had a score 8.0 (moderate disease). A significantly larger proportion of patients achieved clinical improvement and improvement in rectal bleeding in the balsalazide group vs. the placebo group (55 vs. 40, P0.02). The most common adverse events reported were worsening of UC and headache; both were reported more often in the placebo group.CONCLUSIONS: Balsalazide disodium 1.1g tablets administered as 3.3g twice daily are effective, well tolerated and significantly better than placebo for improving signs and symptoms of mild-to-moderately-active UC. This new formulation with a reduced pill and dosing burden offers the potential to improve convenience and compliance in patients with active UC.

    Original languageEnglish (US)
    Pages (from-to)1452-1459
    Number of pages8
    JournalAmerican Journal of Gastroenterology
    Volume104
    Issue number6
    DOIs
    StatePublished - Jun 1 2009

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    Ulcerative Colitis
    Tablets
    Placebos
    Safety
    Hemorrhage
    Patient Compliance
    Double-Blind Method
    Multicenter Studies
    Signs and Symptoms
    Headache
    balsalazide
    Therapeutics

    All Science Journal Classification (ASJC) codes

    • Hepatology
    • Gastroenterology

    Cite this

    Safety and efficacy of a new 3.3g b.i.d. tablet formulation in patients with mild-to-moderately-active ulcerative colitis : A multicenter, randomized, double-blind, placebo-controlled study. / Scherl, Ellen J.; Pruitt, Ronald; Gordon, Glenn L.; Lamet, Mark; Shaw, Audrey; Huang, Shirley; Mareya, Shadreck; Forbes, William P.

    In: American Journal of Gastroenterology, Vol. 104, No. 6, 01.06.2009, p. 1452-1459.

    Research output: Contribution to journalArticle

    Scherl, Ellen J. ; Pruitt, Ronald ; Gordon, Glenn L. ; Lamet, Mark ; Shaw, Audrey ; Huang, Shirley ; Mareya, Shadreck ; Forbes, William P. / Safety and efficacy of a new 3.3g b.i.d. tablet formulation in patients with mild-to-moderately-active ulcerative colitis : A multicenter, randomized, double-blind, placebo-controlled study. In: American Journal of Gastroenterology. 2009 ; Vol. 104, No. 6. pp. 1452-1459.
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    abstract = "OBJECTIVES:To evaluate the safety and efficacy of a new twice-daily balsalazide disodium 1.1g tablet dosing regimen (6.6gday, three tablets twice daily) for the treatment of mild-to-moderately-active ulcerative colitis (UC).METHODS:In a double-blind, multicenter study patients with symptoms of acute UC and a baseline Modified Mayo Disease Activity Index (MMDAI) score between 6 and 10, inclusive, with a subscale rating of 2 for both rectal bleeding and mucosal appearance were randomized to receive 3.3g of balsalazide or placebo tablets twice daily for 8 weeks. The primary end point was the proportion of patients achieving clinical improvement (3 point improvement in MMDAI) and improvement in rectal bleeding (1 point improvement) at 8 weeks. Safety assessments were conducted from baseline through 2-weeks post-treatment.RESULTS:A total of 249 patients (166 balsalazide, 83 placebo) received at least 1 dose of study medication. The mean MMDAI score at baseline was 7.9; 62 of patients had a score 8.0 (moderate disease). A significantly larger proportion of patients achieved clinical improvement and improvement in rectal bleeding in the balsalazide group vs. the placebo group (55 vs. 40, P0.02). The most common adverse events reported were worsening of UC and headache; both were reported more often in the placebo group.CONCLUSIONS: Balsalazide disodium 1.1g tablets administered as 3.3g twice daily are effective, well tolerated and significantly better than placebo for improving signs and symptoms of mild-to-moderately-active UC. This new formulation with a reduced pill and dosing burden offers the potential to improve convenience and compliance in patients with active UC.",
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    T1 - Safety and efficacy of a new 3.3g b.i.d. tablet formulation in patients with mild-to-moderately-active ulcerative colitis

    T2 - A multicenter, randomized, double-blind, placebo-controlled study

    AU - Scherl, Ellen J.

    AU - Pruitt, Ronald

    AU - Gordon, Glenn L.

    AU - Lamet, Mark

    AU - Shaw, Audrey

    AU - Huang, Shirley

    AU - Mareya, Shadreck

    AU - Forbes, William P.

    PY - 2009/6/1

    Y1 - 2009/6/1

    N2 - OBJECTIVES:To evaluate the safety and efficacy of a new twice-daily balsalazide disodium 1.1g tablet dosing regimen (6.6gday, three tablets twice daily) for the treatment of mild-to-moderately-active ulcerative colitis (UC).METHODS:In a double-blind, multicenter study patients with symptoms of acute UC and a baseline Modified Mayo Disease Activity Index (MMDAI) score between 6 and 10, inclusive, with a subscale rating of 2 for both rectal bleeding and mucosal appearance were randomized to receive 3.3g of balsalazide or placebo tablets twice daily for 8 weeks. The primary end point was the proportion of patients achieving clinical improvement (3 point improvement in MMDAI) and improvement in rectal bleeding (1 point improvement) at 8 weeks. Safety assessments were conducted from baseline through 2-weeks post-treatment.RESULTS:A total of 249 patients (166 balsalazide, 83 placebo) received at least 1 dose of study medication. The mean MMDAI score at baseline was 7.9; 62 of patients had a score 8.0 (moderate disease). A significantly larger proportion of patients achieved clinical improvement and improvement in rectal bleeding in the balsalazide group vs. the placebo group (55 vs. 40, P0.02). The most common adverse events reported were worsening of UC and headache; both were reported more often in the placebo group.CONCLUSIONS: Balsalazide disodium 1.1g tablets administered as 3.3g twice daily are effective, well tolerated and significantly better than placebo for improving signs and symptoms of mild-to-moderately-active UC. This new formulation with a reduced pill and dosing burden offers the potential to improve convenience and compliance in patients with active UC.

    AB - OBJECTIVES:To evaluate the safety and efficacy of a new twice-daily balsalazide disodium 1.1g tablet dosing regimen (6.6gday, three tablets twice daily) for the treatment of mild-to-moderately-active ulcerative colitis (UC).METHODS:In a double-blind, multicenter study patients with symptoms of acute UC and a baseline Modified Mayo Disease Activity Index (MMDAI) score between 6 and 10, inclusive, with a subscale rating of 2 for both rectal bleeding and mucosal appearance were randomized to receive 3.3g of balsalazide or placebo tablets twice daily for 8 weeks. The primary end point was the proportion of patients achieving clinical improvement (3 point improvement in MMDAI) and improvement in rectal bleeding (1 point improvement) at 8 weeks. Safety assessments were conducted from baseline through 2-weeks post-treatment.RESULTS:A total of 249 patients (166 balsalazide, 83 placebo) received at least 1 dose of study medication. The mean MMDAI score at baseline was 7.9; 62 of patients had a score 8.0 (moderate disease). A significantly larger proportion of patients achieved clinical improvement and improvement in rectal bleeding in the balsalazide group vs. the placebo group (55 vs. 40, P0.02). The most common adverse events reported were worsening of UC and headache; both were reported more often in the placebo group.CONCLUSIONS: Balsalazide disodium 1.1g tablets administered as 3.3g twice daily are effective, well tolerated and significantly better than placebo for improving signs and symptoms of mild-to-moderately-active UC. This new formulation with a reduced pill and dosing burden offers the potential to improve convenience and compliance in patients with active UC.

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    U2 - 10.1038/ajg.2009.83

    DO - 10.1038/ajg.2009.83

    M3 - Article

    VL - 104

    SP - 1452

    EP - 1459

    JO - American Journal of Gastroenterology

    JF - American Journal of Gastroenterology

    SN - 0002-9270

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