40513
document
Safety and efficacy of a new 3.3 g b.i.d . tablet formulation in patients with mild-to-moderately-active ulcerative colitis : a multicenter , randomized , double-blind , placebo-controlled study . OBJECTIVES To evaluate the safety and efficacy of a new twice-daily balsalazide disodium 1.1 g tablet dosing regimen ( 6.6 g/day , 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 > or =2 for both rectal bleeding and mucosal appearance were randomized to receive 3.3 g of balsalazide or placebo tablets twice daily for 8 weeks . The primary end point was the proportion of patients achieving clinical improvement ( > or =3 point improvement in MMDAI ) and improvement in rectal bleeding ( > or =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 > or =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 % , P=0.02 ) . The most common adverse events reported were worsening of UC and headache ; both were reported more often in the placebo group . CONCLUSIONS Balsalazide disodium 1.1 g tablets administered as 3.3 g 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 .
40514
Intervention_Pharmacological
new 3.3 g b.i.d . tablet formulation
40515
Intervention_Pharmacological
balsalazide disodium 1.1 g tablet
40516
Intervention_Pharmacological
balsalazide
40517
Intervention_Pharmacological
placebo
40518
Intervention_Pharmacological
balsalazide
40519
Intervention_Control
placebo
40520
Intervention_Pharmacological
balsalazide
40521
Intervention_Control
placebo
40522
Intervention_Control
placebo
40523
Intervention_Pharmacological
Balsalazide disodium
40524
Intervention_Pharmacological
placebo
40525
Outcome_Other
Safety and efficacy
40526
Outcome_Other
safety and efficacy
40527
Outcome_Physical
mean MMDAI score
40528
Outcome_Physical
clinical improvement
40529
Outcome_Physical
improvement in rectal bleeding
40530
Outcome_Adverse-effects
worsening of UC
40531
Outcome_Adverse-effects
headache
40532
Outcome_Other
effective
40533
Outcome_Other
well tolerated
40534
Outcome_Physical
better
40535
Outcome_Physical
signs and symptoms of mild-to-moderately-active UC
40536
Outcome_Other
convenience
40537
Outcome_Mental
compliance
40538
Participant_Condition
ulcerative colitis
40539
Participant_Condition
acute UC
40540
Participant_Sample-size
249
40541
Participant_Sample-size
166
40542
Participant_Sample-size
83
40543
Participant_Condition
active UC