scholarly journals Delayed-Release Oral Mesalamine 4.8 g/day (800 mg tablets) Compared with 2.4 g/day (400 mg tablets) for the Treatment of Mildly to Moderately Active Ulcerative Colitis: The ASCEND I Trial

2007 ◽  
Vol 21 (12) ◽  
pp. 827-834 ◽  
Author(s):  
Stephen B Hanauer ◽  
William J Sandborn ◽  
Christian Dallaire ◽  
André Archambault ◽  
Bruce Yacyshyn ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Initial Dose ◽  
Controlled Trial ◽  
Treatment Success ◽  
Response To Therapy ◽  
Active Ulcerative Colitis ◽  
Double Blind ◽  
Delayed Release ◽  
End Point ◽  
Moderate Disease

BACKGROUND: Delayed-release oral mesalamine 2.4 g/day to 4.8 g/day has been shown to be effective in treating mildly to moderately active ulcerative colitis (UC), but it is unknown whether an initial dose of 4.8 g/day is more effective than 2.4 g/day in patients with mildly to moderately active UC and in the subgroup with moderate disease.PATIENTS AND METHODS: A six-week, multicentre, randomized, double-blind, controlled trial assessing the safety and clinical efficacy of a new dose (ASCEND I) of medication randomly assigned 301 adults with mildly to moderately active UC to delayed-release oral mesalamine 2.4 g/day (400 mg tablet [n=154]) or 4.8 g/day (800 mg tablet [n=147]). The primary efficacy end point was overall improvement (ie, treatment success), defined as complete remission or response to therapy from baseline to week 6. Primary safety end points were adverse events and laboratory evaluations. Data were also analyzed separately for the prespecified subgroup of patients with moderate UC at baseline.RESULTS: Treatment success was not statistically different between the treatment groups at week 6; 51% of the group (77 of 150) who received delayed-release oral mesalamine 2.4 g/day and 56% of the group (76 of 136) who received 4.8 g/day reached the efficacy end point (P=0.441). Among the moderate disease subgroup, however, the higher initial dose was more effective; 57% of patients (53 of 93) given delayed-release oral mesalamine 2.4 g/day and 72% of patients (55 of 76) given 4.8 g/day achieved treatment success (P=0.0384). Both regimens were well tolerated.CONCLUSIONS: Delayed-release oral mesalamine is an effective and well-tolerated initial therapy in patients with mildly to moderately active UC, and a 4.8 g/day dose may enhance treatment success rates in patients with moderate disease compared with mesalamine 2.4 g/day.

scholarly journals A Phase 2a, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of IBD98-M Delayed-Release Capsules to Induce Remission in Patients with Active and Mild to Moderate Ulcerative Colitis

Cells ◽  
2019 ◽  
Vol 8 (6) ◽  
pp. 523 ◽  
Author(s):  
Gionata Fiorino ◽  
Giacomo Carlo Sturniolo ◽  
Fabrizio Bossa ◽  
Andrea Cassinotti ◽  
Antonio Di Sabatino ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Activity Index ◽  
Controlled Trial ◽  
Disease Activity Index ◽  
Fecal Calprotectin ◽  
Summary Score ◽  
Double Blind ◽  
Release Formulation ◽  
Delayed Release

IBD98-M is a delayed-release formulation of mesalamine (mesalazine) and SH with a potential therapeutic role in ulcerative colitis (UC). A total of 51 patients with a modified Ulcerative Colitis Disease Activity Index (UCDAI) score of ≥4 and ≤10, and a modified UCDAI endoscopy subscore ≥1 were randomized for 6 weeks of double-blind treatment with IBD98 0.8 g/day or IBD 1.2 g/day or placebo. The efficacy and safety of IBD98-M in mild to moderate active UC were primarily evaluated. At week 6, 1 (5.9%), 2 (12.5%), and 2 (11.1%) patients receiving IBD98-M 0.8 g, IBD98-M 1.2 g, and placebo, respectively, (p > 0.999) achieved clinical remission. Higher clinical response was seen in IBD98-M 1.2 g (31.3%) versus placebo (16.7%) and endoscopic improvement in IBD98-M 0.8 g (29.4%) versus placebo (22.2%) was seen. Fecal calprotectin levels were reduced in IBD98-M groups versus placebo (p > 0.05). IBD98-M patients achieved significant improvement in physical health summary score component of the SF-36 (p = 0.01 and p = 0.03 respectively) compared to placebo. IBD98-M did not meet the primary end point but had higher clinical response (1.2 g/day) and endoscopic improvement (0.8 g/day) compared to placebo. The safety result shown that IBD98-M treatment was safe and well tolerated in this patient population. No new safety signals or unexpected safety findings were observed during the study. Further trials with different stratification and longer follow-up may be needed to evaluate the efficacy.

Sa1977 A Randomised, Double-Blind Study of High and Low Dose Oral Delayed-Release Mesalamine Does Not Demonstrate a Difference in Treating Mild to Moderately Active Ulcerative Colitis in Children

2012 ◽  
Vol 142 (5) ◽  
pp. S-371-S-372
Author(s):  
Harland S. Winter ◽  
Barbara Iwanczak ◽  
Melvin B. Heyman ◽  
Eduardo Ibarguen-Secchia ◽  
Maciej Kaczmarski ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Low Dose ◽  
Blind Study ◽  
Double Blind Study ◽  
Active Ulcerative Colitis ◽  
Double Blind ◽  
Delayed Release ◽  
Dose Oral

scholarly journals OP34 VARSITY: A double-blind, double-dummy, randomised, controlled trial of vedolizumab versus adalimumab in patients with active ulcerative colitis

2019 ◽  
Vol 13 (Supplement_1) ◽  
pp. S612-S613 ◽  
Author(s):  
Stefan Schreiber ◽  
Laurent Peyrin-Biroulet ◽  
Edward V Loftus ◽  
Silvio Danese ◽  
Jean-Frederic Colombel ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Active Ulcerative Colitis ◽  
Double Blind ◽  
Randomised Controlled

scholarly journals OP30 Lyophilised orally administered faecal microbiota transplantation for Active Ulcerative Colitis (LOTUS study)

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S029-S029
Author(s):  
C Haifer ◽  
A Saikal ◽  
S Paramsothy ◽  
T J Borody ◽  
S Ghaly ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Controlled Trial ◽  
Active Ulcerative Colitis ◽  
Faecal Microbiota ◽  
Double Blind ◽  
Faecal Microbiota Transplantation ◽  
Endoscopic Remission ◽  
Remission Rates ◽  
Pre Treatment

Abstract Background Faecal microbiota transplantation (FMT) administered via the lower GI tract effectively induces remission in ulcerative colitis (UC). Orally administered FMT capsules may improve patient tolerability and facilitate maintenance therapy while it is unclear if pre-FMT antibiotics enhance therapeutic efficacy. Methods We performed a dual-centre randomised, double blind, placebo-controlled trial of oral lyophilised FMT in adults with mild-moderately active UC (total Mayo 4–10). All subjects received 2-weeks of pre-FMT antibiotics (amoxycillin, metronidazole and doxycycline) before 1:1 randomisation to either oral FMT (0.35g stool content per capsule from 1 of 2 healthy donors) or identical placebo for 8 weeks. Enforced tapering and cessation of corticosteroids was mandated. The primary endpoint was week 8 steroid-free clinical remission with endoscopic remission or response (total Mayo score ≤2 with subscores ≤ 1 for rectal bleeding, stool frequency and endoscopic appearance, and ≥1-point reduction from baseline in endoscopy subscore). Responders to FMT induction were re-randomised to either continue maintenance FMT or withdrawal of FMT with final outcomes assessed at week 56. Results Recruitment was paused due to the COVID-19 pandemic. 37 patients were randomised. Baseline patient and disease characteristics were balanced between the randomised groups. The primary outcome was achieved in 8/16 (50%) receiving FMT versus 3/19 (16%) receiving placebo (OR: 4.63; 95%CI: 1.74–12.30; P=0.002). Steroid-free clinical remission rates and endoscopic remission rates were 69% vs 26% (P=0.012) and 44% vs 16% (P=0.074) in the FMT and placebo arms, respectively. Reported SAE were worsening colitis (2 FMT, 1 placebo) and PR bleeding relating to previous anal surgery (placebo). Ten patients entered the maintenance withdrawal study. Steroid-free clinical, endoscopic and histologic remission was achieved in 4/4 patients who continued daily oral FMT, with all 6 patients randomised to FMT withdrawal having a flare of disease with a median time to relapse of 6 months. Conclusion Oral lyophilised FMT following antibiotic pre-treatment for mild-moderately active ulcerative colitis was associated with a significant increased rate of clinical remission with endoscopic remission or response versus antibiotic treatment alone at week 8. Pre-treatment antibiotics had an additive impact upon treatment efficacy compared with previous studies utilising FMT. Maintenance FMT therapy was associated with sustained clinical, endoscopic and histologic remission at week 56. Treatment was well tolerated and there were no new safety signals related to FMT therapy.

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