Clinical trial: Randomized-controlled clinical study comparing the efficacy and safety of a low-volume vs. a high-volume mesalazine foam in active distal ulcerative colitis

Alimentary Pharmacology and Therapeutics

Volumn 26, Issue 9, 2007, Pages 1237-1249

  Eliakim, R ^a   Tulassay, Z ^b   Kupcinskas, L ^c   Adamonis, K ^d   Pokrotnieks, J ^e   Bar Meir, S ^f   Lavy, A ^g   Mueller, R ^h   Greinwald, R ^h   Chermesh, I ^a   Gross, V ⁱ  

^a RAMBAM MEDICAL CENTER   (Israel)

^b SEMMELWEIS UNIVERSITY OF MEDICINE   (Hungary)

^c KAUNAS UNIVERSITY OF MEDICINE   (Lithuania)

^d Department of Endoscopy   (Lithuania)

^e PAULS STRADINS CLINICAL UNIVERSITY HOSPITAL   (Latvia)

^f TEL AVIV UNIVERSITY   (Israel)

^g BNAI ZION MEDICAL CENTER   (Israel)

^h Dr Falk Pharma GmbH   (Germany)

ⁱ KLINIKUM ST MARIEN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

CORTICOSTEROID; MESALAZINE; SALAZOSULFAPYRIDINE;

ADULT; AGED; ARTICLE; BREAST DISEASE; CLINICAL TRIAL; CONNECTIVE TISSUE DISEASE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG INTOXICATION; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FOAM; GASTROINTESTINAL DISEASE; HEART DISEASE; HEPATOBILIARY DISEASE; HUMAN; INFECTION; INFESTATION; KIDNEY DISEASE; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; MENTAL DISEASE; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; NEUROLOGIC DISEASE; PAIN; PATIENT COMPLIANCE; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; REMISSION; REPRODUCTIVE TOXICITY; RESPIRATORY TRACT DISEASE; SINGLE BLIND PROCEDURE; SKIN DISEASE; THORAX DISEASE; TREATMENT OUTCOME; ULCERATIVE COLITIS; UNSPECIFIED SIDE EFFECT; VASCULAR DISEASE;

ADMINISTRATION, RECTAL; ADOLESCENT; ADULT; AGED; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; COLITIS, ULCERATIVE; FEMALE; HUMANS; MALE; MESALAMINE; MIDDLE AGED; SINGLE-BLIND METHOD; TREATMENT OUTCOME;

EID: 35449008088     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/j.1365-2036.2007.03468.x     Document Type: Article

References (32)

1. Carter MJ, Lobo AJ, Travis SPL, on behalf of the IBD Section of the British Society of Gastroenterology. Guidelines for the management of inflammatory bowel disease in adults. Gut 2004 53 : V1 16.
2. Gisbert JP, Gomollon F, Mate J, Pajares JM. Role of 5-aminosalicylic acid (5-ASA) in treatment of inflammatory bowel disease - a systematic review. Dig Dis Sci 2002 47 : 471 88.
3. Hanauer SB. Medical therapy for ulcerative colitis 2004 (review). Gastroenterology 2004 126 : 1582 92.
4. Hoffmann JC, Zeitz M, Bischoff SC, et al. Diagnosis and therapy of ulcerative colitis: results of an evidence based consensus conference by the German Society of Digestive and Metabolic Diseases and the Competence Network on Inflammatory Bowel Disease (in German). Z Gastroenterol 2004 42 : 979 1032.
5. Kornbluth A, Sachar DB. Ulcerative colitis practice guidelines in adults (update): American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol 2004 99 : 1371 85.
6. Vecchi M, Saibeni S, Devani M, Rondonotti E, de Franchis R. Review article: Diagnosis, monitoring and treatment of distal colitis. Aliment Pharmacol Ther 2003 17 : 2 6.
7. Hanauer SB. Review article: Aminosalicylates in inflammatory bowel disease. Aliment Pharmacol Ther 2004 20 : 60 5.
8. Marshall JK, Irvine EJ. Rectal aminosalicylate therapy for distal ulcerative colitis: a meta-analysis. Aliment Pharmacol Ther 1995 9 : 293 300.
9. Marshall JK, Irvine EJ. Putting rectal 5-aminosalicylic acid in its place: the role in distal ulcerative colitis. Am J Gastroenterol 2000 95 : 1628 36.
10. Cohen RD, Woseth DM, Thisted RA, Hanauer SB. A meta-analysis and overview of the literature on treatment options for left-sided ulcerative colitis and ulcerative proctitis. Am J Gastroenterol 2000 95 : 1263 76.
11. Malchow H, Gertz B. A new mesalazine foam enema (Claversal Foam) compared with a standard liquid enema in patients with active distal ulcerative colitis. Aliment Pharmacol Ther 2002 16 : 415 23.
12. Pokrotnieks J, Marlicz K, Paradowski L, Margus B, Zaborowski P, Greinwald R. Efficacy and tolerability of mesalazine foam enema (Salofalk foam) for distal ulcerative colitis: a double-blind, randomized, placebo-controlled study. Aliment Pharmacol Ther 2000 14 : 1191 8.
13. Rachmilewitz D. Coated mesalazine (5-aminosalicylic acid) versus sulphasalazine in the treatment of active ulcerative colitis: a randomised trial. BMJ 1989 298 : 82 6.
14. Sutherland LR, Martin F, Greer S, et al. 5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis. Gastroenterology 1987 92 : 1894 8.
15. Riley SA, Mani V, Goodman MJ, Dutt S, Herd ME. Microscopic activity in ulcerative colitis: what does it mean? Gut 1991 32 : 174 8.
16. Hanauer S, Schwartz J, Robinson M, et al. Mesalamine capsules for treatment of active ulcerative colitis: results of a controlled trial. Pentasa Study Group. Am J Gastroenterol 1993 88 : 1188 97.
17. Wang SK, Tsiatis AA. Approximately optimal one-parameter boundaries for group sequential trials. Biometrics 1987 43 : 193 9.
18. Lehmacher W, Wassmer G. Adaptive sample size calculations in group sequential trials. Biometrics 1999 55 : 1286 90.
19. O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979 35 : 549 56.
20. ADDPLAN GmbH. ADDPLAN - Adaptive Designs, Plans and Analyses, Release 2.0. Germany : 2003.
21. Farrington CP, Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Stat Med 1990 9 : 1447 54.
22. Jennison C, Turnbull BW. Group sequential tests and repeated confidence intervals. In : Ghosh BK, Sen PK, eds. Handbook of Sequential Analysis. New York : Marcel Dekker, 1991 : 283 311.
23. Gross V, Bar-Meir S, Lavy A, et al. Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis. Aliment Pharmacol Ther 2006 23 : 303 12.
24. Ardizzone S, Doldo P, Ranzi T, et al. Mesalazine foam (Salofalk foam) in the treatment of active distal ulcerative colitis. A comparative trial vs Salofalk enema. The SAF-3 study group. Ital J Gastroenterol Hepatol 1999 31 : 677 84.
25. Rutter M, Saunders B, Wilkinson K, et al. Severity of inflammation is a risk factor for colorectal neoplasia in ulcerative colitis. Gastroenterology 2004 126 : 451 9.
26. Rutter MD, Saunders BP, Wilkinson KH, et al. Cancer surveillance in longstanding ulcerative colitis: endoscopic appearances help predict cancer risk. Gut 2004 53 : 1813 6.
27. Gibson PR, Fixa B, Pekarkova B, et al. Comparison of the efficacy and safety of Eudragit-L-coated mesalazine tablets with ethylcellulose-coated mesalazine tablets in patients with mild to moderately active ulcerative colitis. Aliment Pharmacol Ther 2006 23 : 1017 26.
28. Hanauer SB, Sandborn WJ, Kornbluth A, et al. Delayed-release oral mesalamine at 4.8 g/day (800 mg tablet) for the treatment of moderately active ulcerative colitis: the ASCEND II trial. Am J Gastroenterol 2005 100 : 2478 85.
29. Marteau P, Probert CS, Lindgren S, et al. Combined oral and enema treatment with Pentasa (mesalazine) is superior to oral therapy alone in patients with extensive mild/moderate active ulcerative colitis: a randomised, double blind, placebo controlled study. Gut 2005 54 : 960 5.
30. Dilger K, Cap M, Camatta G, Stengele E, Trenk D. Relative bioavailability of mesalazine comparing different rectal formulations with oral delayed release granules. Int J Clin Pharmacol Ther 2006 44 : 525 6.
31. Loftus EV, Kane SV, Bjorkman D. Systematic review: Short-term adverse effects of 5-aminosalicylic acid agents in the treatment of ulcerative colitis. Aliment Pharmacol Ther 2004 19 : 179 89.
32. Bar-Meir S, Fidder HH, Faszczyk M, et al. Budesonide foam vs. hydrocortisone acetate foam in the treatment of active ulcerative proctosigmoiditis. Dis Colon Rectum 2003 46 : 929 36.