Page last updated: 2024-10-30

mesalamine and Proctitis

mesalamine has been researched along with Proctitis in 82 studies

Mesalamine: An anti-inflammatory agent, structurally related to the SALICYLATES, which is active in INFLAMMATORY BOWEL DISEASE. It is considered to be the active moiety of SULPHASALAZINE. (From Martindale, The Extra Pharmacopoeia, 30th ed)
mesalamine : A monohydroxybenzoic acid that is salicylic acid substituted by an amino group at the 5-position.

Proctitis: INFLAMMATION of the MUCOUS MEMBRANE of the RECTUM, the distal end of the large intestine (INTESTINE, LARGE).

Research Excerpts

ExcerptRelevanceReference
"This study showed that a daily bedtime dose of a 500 mg mesalamine suppository is safe and efficacious in children with ulcerative proctitis."9.14Efficacy and safety of mesalamine suppositories for treatment of ulcerative proctitis in children and adolescents. ( Giguere, M; Heyman, MB; Kierkus, J; Shbaklo, H; Spénard, J, 2010)
"Mesalamine suppositories are first-line therapy in active ulcerative proctitis; the standard regime still recommends multiple doses per day."9.14Clinical trial: a novel high-dose 1 g mesalamine suppository (Salofalk) once daily is as efficacious as a 500-mg suppository thrice daily in active ulcerative proctitis. ( Andus, T; Baranovsky, A; Cascorbi, I; Dilger, K; Dorofeyev, AE; Greinwald, R; Kocjan, A; Lozynskyy, YS; Mikhailova, TL; Mohrbacher, R; Müser, M; Stolte, M; Vieth, M; Zvyagintseva, TD, 2010)
"To evaluate the effectiveness of metronidazole in combination with corticosteroids in enema and mesalazine (5-aminosalicylic acid) in comparison with the same protocol without metronidazole in the treatment of chronic radiation proctitis."9.09Metronidazole in the treatment of chronic radiation proctitis: clinical trial. ( Cavcić, J; Jelincić, Z; Martinac, P; Panijan-Pezerović, R; Turcić, J; Unusić, J; Zupancić, B, 2000)
"The therapeutic efficacy of 1 g 5-aminosalicylic acid enema was compared with that of 90 mg hydrocortisone acetate foam following daily rectal administration to patients with idiopathic proctitis or proctosigmoiditis during two weeks."9.07[5-aminosalicylic acid enema (Pentasa) versus hydrocortisone acetate foam (Proctocort) for the treatment of outbreaks of proctitis and cryptogenetic proctosigmoiditis. A comparative randomized multicenter trial]. ( Ngô, Y; Rambaud, JC, 1992)
" We present a case of an 8-year-old female patient with intolerance to mesalamine and proctitis resistant to conventional therapy who responded to rectal tacrolimus treatment."7.80Successful treatment for ulcerative proctitis with rectal tacrolimus in an 8-year-old girl with intolerance to mesalamine. ( Blasco-Alonso, J; Gallego-Gutiérrez, S; Girón Fernández-Crehuet, F; Luque Pérez, S; Navas-López, VM; Serrano Nieto, MJ; Sierra Salinas, C, 2014)
"Mesalamine was well tolerated."6.76A multicenter, randomized study to evaluate the efficacy and safety of mesalamine suppositories 1 g at bedtime and 500 mg Twice daily in patients with active mild-to-moderate ulcerative proctitis. ( Lamet, M, 2011)
" There was no significant difference between treatments in adverse events, and both groups had an overall drug compliance of greater than 95%."6.71Efficacy and safety of mesalamine 1 g HS versus 500 mg BID suppositories in mild to moderate ulcerative proctitis: a multicenter randomized study. ( Dallaire, C; de Montigny, D; Grace, M; Lamet, M; Ptak, T; Shah, U; Spenard, J, 2005)
"Marks score or the ulcerative colitis disease-activity index) at two and four weeks."6.71Epidermal growth factor enemas with oral mesalamine for mild-to-moderate left-sided ulcerative colitis or proctitis. ( Berlanga-Acosta, J; Nightingale, J; Playford, RJ; Sinha, A; West, KP, 2003)
"This study showed that a daily bedtime dose of a 500 mg mesalamine suppository is safe and efficacious in children with ulcerative proctitis."5.14Efficacy and safety of mesalamine suppositories for treatment of ulcerative proctitis in children and adolescents. ( Giguere, M; Heyman, MB; Kierkus, J; Shbaklo, H; Spénard, J, 2010)
"Mesalamine suppositories are first-line therapy in active ulcerative proctitis; the standard regime still recommends multiple doses per day."5.14Clinical trial: a novel high-dose 1 g mesalamine suppository (Salofalk) once daily is as efficacious as a 500-mg suppository thrice daily in active ulcerative proctitis. ( Andus, T; Baranovsky, A; Cascorbi, I; Dilger, K; Dorofeyev, AE; Greinwald, R; Kocjan, A; Lozynskyy, YS; Mikhailova, TL; Mohrbacher, R; Müser, M; Stolte, M; Vieth, M; Zvyagintseva, TD, 2010)
"To evaluate the effectiveness of metronidazole in combination with corticosteroids in enema and mesalazine (5-aminosalicylic acid) in comparison with the same protocol without metronidazole in the treatment of chronic radiation proctitis."5.09Metronidazole in the treatment of chronic radiation proctitis: clinical trial. ( Cavcić, J; Jelincić, Z; Martinac, P; Panijan-Pezerović, R; Turcić, J; Unusić, J; Zupancić, B, 2000)
"The therapeutic efficacy of 1 g 5-aminosalicylic acid enema was compared with that of 90 mg hydrocortisone acetate foam following daily rectal administration to patients with idiopathic proctitis or proctosigmoiditis during two weeks."5.07[5-aminosalicylic acid enema (Pentasa) versus hydrocortisone acetate foam (Proctocort) for the treatment of outbreaks of proctitis and cryptogenetic proctosigmoiditis. A comparative randomized multicenter trial]. ( Ngô, Y; Rambaud, JC, 1992)
" We present a case of an 8-year-old female patient with intolerance to mesalamine and proctitis resistant to conventional therapy who responded to rectal tacrolimus treatment."3.80Successful treatment for ulcerative proctitis with rectal tacrolimus in an 8-year-old girl with intolerance to mesalamine. ( Blasco-Alonso, J; Gallego-Gutiérrez, S; Girón Fernández-Crehuet, F; Luque Pérez, S; Navas-López, VM; Serrano Nieto, MJ; Sierra Salinas, C, 2014)
"Mesalazine, betamethasone, and misoprostol are the best topical agents for radiation proctitis and formalin has an inflammatory effect and should not be used."3.73Histopathological comparison of topical therapy modalities for acute radiation proctitis in an experimental rat model. ( Aksoy, M; Asoglu, O; Bilge, H; Kapran, Y; Kiremit-Korkut, N; Korkut, C; Parlak, M, 2006)
" She had been diagnosed 2 months before as having ulcerative proctitis and was treated with mesalamine, which induced a full remission, but 3 antibiotic regimens failed to improve her lung disease."3.70[Mesalamine-induced hypersensitivity pneumonitis]. ( Fireman, Z; Weiner, P; Weizman, J; Zamir, C; Zamir, D, 1999)
"Proctitis is the least extensive type of ulcerative colitis, for which rectal therapy is rarely studied and is underused."3.11Novel Budesonide Suppository and Standard Budesonide Rectal Foam Induce High Rates of Clinical Remission and Mucosal Healing in Active Ulcerative Proctitis: a Randomised, Controlled, Non-inferiority Trial. ( Abdulkhakov, S; Abrahamovych, O; Alexeeva, O; Andreev, P; Baluta, M; Datsenko, O; Delmans, G; Dorofeyev, A; Greinwald, R; Kharchenko, N; Khimion, L; Kolesnik, IP; Kruis, W; Lesniakowski, K; Levchenko, O; Maksyashina, SV; Mihaly, E; Mohrbacher, R; Mostovoy, Y; Mueller, R; Pokrotnieks, J; Sablin, OA; Siegmund, B; Simanenkov, V; Sobon, M; Uspenskiy, Y; Viacheslav, N; Vieth, M, 2022)
"Although proctitis is the most limited form of ulcerative colitis, it causes unpleasant symptoms."2.90Budesonide Suppositories Are Effective and Safe for Treating Acute Ulcerative Proctitis. ( Abdulkhakov, S; Alekseeva, O; Andreev, P; Datsenko, O; Dorofeyev, AE; Greinwald, R; Kruis, W; Levchenko, O; Lozynskyy, Y; Mohrbacher, R; Mostovoy, Y; Neshta, V; Pesegova, M; Siegmund, B; Soloviev, K; Stiess, M; Vieth, M, 2019)
" The frequency of adverse events was comparable between groups, regardless of baseline 5-ASA use."2.82Baseline Oral 5-ASA Use and Efficacy and Safety of Budesonide Foam in Patients with Ulcerative Proctitis and Ulcerative Proctosigmoiditis: Analysis of 2 Phase 3 Studies. ( Bosworth, BP; Harper, JR; Rubin, DT; Sandborn, WJ, 2016)
"Ulcerative proctitis is a common and often highly symptomatic form of inflammatory bowel disease."2.82Efficacy of Pharmacological Agents for Ulcerative Proctitis: A Systematic Literature Review. ( Caron, B; Danese, S; Hart, A; Panaccione, R; Peyrin-Biroulet, L; Sandborn, WJ; Schreiber, S; Solitano, V, 2022)
"Marks score or the ulcerative colitis disease-activity index) at two and four weeks."2.71Epidermal growth factor enemas with oral mesalamine for mild-to-moderate left-sided ulcerative colitis or proctitis. ( Berlanga-Acosta, J; Nightingale, J; Playford, RJ; Sinha, A; West, KP, 2003)
" The dose-response relationship was statistically significant (p = 0."2.69Maintenance treatment of ulcerative proctitis with mesalazine suppositories: a double-blind placebo-controlled trial. The Italian IBD Study Group. ( Bianchi Porro, G; Campieri, M; d'Albasio, G; Miglioli, M; Paoluzi, P; Pera, A; Prantera, C; Sturniolo, GC, 1998)
"Thirty-eight patients with distal ulcerative colitis (n = 17) or ulcerative proctitis (n = 21) in clinical, endoscopic, and histologic remission were randomly assigned to receive either oral mesalazine (0."2.67Intermittent therapy with high-dose 5-aminosalicylic acid enemas maintains remission in ulcerative proctitis and proctosigmoiditis. ( Hatzis, A; Mantzaris, GJ; Petraki, K; Spiliadi, C; Triantaphyllou, G, 1994)
"Thirty patients with distal ulcerative colitis in remission (17 proctitis, 13 proctosigmoiditis) were randomly given either 5-aminosalicylic acid (5-ASA) or placebo suppositories, 400 mg bid."2.675-Aminosalicylic acid suppositories in the maintenance of remission in idiopathic proctitis or proctosigmoiditis: a double-blind placebo-controlled clinical trial. ( Boscaino, A; D'Arienzo, A; D'Armiento, FP; Giannattasio, F; Lancia, C; Mazzacca, G; Panarese, A; Quattrone, P, 1990)
"Conventional therapies for ulcerative colitis and Crohn's disease (CD) include aminosalicylates, corticosteroids, thiopurines, methotrexate, and anti-tumor necrosis factor agents."2.47Conventional medical management of inflammatory bowel disease. ( Burger, D; Travis, S, 2011)
"Optimizing treatment goals in ulcerative colitis requires recognizing the needs of patients."2.46Best practice in the management of mild-to-moderately active ulcerative colitis and achieving maintenance of remission using mesalazine. ( Elkjaer, M; Marteau, P; Michetti, P; Munkholm, P; Probert, CS, 2010)
" Mesalamine enema dosing intervals between QHS to Q3 days maintained efficacy."2.41A meta-analysis and overview of the literature on treatment options for left-sided ulcerative colitis and ulcerative proctitis. ( Cohen, RD; Hanauer, SB; Thisted, RA; Woseth, DM, 2000)
"An increase incidence of ulcerative colitis (UC) has been reported in Mexico."1.51Ulcerative colitis: epidemiology, clinical features and associated factors with surgical treatment in a tertiary hospital in Mexico. ( Alarcón-Bernés, L; Gracida-Mancilla, NI; Jiménez-Bobadilla, B; León-Rendón, JL; López-Pérez, RY; Villanueva Herrero, JA, 2019)
"Linear IgA bullous dermatosis is a rare bullous disease in children and adults that can be associated with autoimmune conditions, malignancies, infections, or medication exposure."1.48Linear IgA bullous dermatosis associated with ulcerative proctitis: treatment challenge. ( Burns, C; Yetto, T, 2018)
"Whether the epidemiology of ulcerative colitis (UC) has changed during recent decades is partly unknown."1.46Changes in medical management and colectomy rates: a population-based cohort study on the epidemiology and natural history of ulcerative colitis in Örebro, Sweden, 1963-2010. ( Cao, Y; Eriksson, C; Halfvarson, J; Henriksson, I; Montgomery, S; Rundquist, S; Zhulina, Y, 2017)
"Although some ulcerative colitis (UC) patients are diagnosed when they do not have any UC-related symptoms, clinical features and prognosis of UC diagnosed in asymptomatic patients remain unclear."1.40Clinical features and course of ulcerative colitis diagnosed in asymptomatic subjects. ( Byeon, JS; Jung, KW; Kim, J; Kim, JH; Kim, JW; Kim, KJ; Kim, SO; Myung, SJ; Park, SH; Park, SK; Yang, DH; Yang, SK; Ye, BD, 2014)
"Topical treatment in proctitis patients was underused in Switzerland."1.40Topical therapy is underused in patients with ulcerative colitis. ( Beglinger, C; Fournier, N; Mottet, C; Pittet, V; Rogler, G; Seibold, F, 2014)
"Radiation proctitis is a common complication of pelvic radiation for which an optimal treatment remains undetermined."1.37The efficacy of the combination therapy with oral and topical mesalazine for patients with the first episode of radiation proctitis. ( Joo, HR; Kim, TG; Kim, TO; Moon, YS; Park, J; Park, MJ; Park, SH; Ryu, DY; Seo, EH; Song, GA; Yang, SY, 2011)
"Radiation proctitis is a well-known complication of abdominal and pelvic radiation."1.28Failure of 5-aminosalicylic acid enemas to improve chronic radiation proctitis. ( Baum, CA; Biddle, WL; Miner, PB, 1989)

Research

Studies (82)

TimeframeStudies, this research(%)All Research%
pre-19908 (9.76)18.7374
1990's16 (19.51)18.2507
2000's17 (20.73)29.6817
2010's32 (39.02)24.3611
2020's9 (10.98)2.80

Authors

AuthorsStudies
Nunes, VRT1
Vidigal, PVT1
Pereira, MT1
Ladeira, LCD1
Caliari, MV1
Oliveira, FMS1
Cesar, ALA1
Faraco, AAG1
Barbuto, RC1
Duval-Araujo, I1
Caron, B4
Sandborn, WJ3
Panaccione, R2
Schreiber, S2
Hart, A1
Solitano, V1
Danese, S3
Peyrin-Biroulet, L3
Kruis, W2
Siegmund, B2
Lesniakowski, K1
Simanenkov, V1
Khimion, L1
Sobon, M1
Delmans, G1
Maksyashina, SV1
Sablin, OA1
Pokrotnieks, J1
Mostovoy, Y2
Datsenko, O2
Abdulkhakov, S2
Dorofeyev, A1
Levchenko, O2
Alexeeva, O1
Andreev, P2
Kolesnik, IP1
Mihaly, E1
Abrahamovych, O1
Baluta, M1
Kharchenko, N1
Viacheslav, N1
Uspenskiy, Y1
Vieth, M3
Mohrbacher, R3
Mueller, R1
Greinwald, R4
Aruljothy, A1
Singh, S1
Narula, N1
Moran, GW1
Vuyyuru, SK1
Hogan, M1
Zayadi, A1
MacDonald, JK1
Peyrin Biroulet, L1
Ma, C1
Jairath, V1
Lie, MRKL1
Kreijne, JE1
Dijkstra, G1
Löwenberg, M1
van Assche, G1
West, RL1
van Noord, D1
van der Meulen-de Jong, AE1
Oldenburg, B1
Zaal, RJ1
Hansen, BE1
de Vries, AC1
Janneke van der Woude, C1
Dubois, E1
Moens, A1
Geelen, R1
Sabino, J1
Ferrante, M1
Vermeire, S1
Ungar, B1
Kopylov, U2
Harbord, M1
Eliakim, R1
Bettenworth, D1
Karmiris, K1
Katsanos, K1
Kucharzik, T1
Molnár, T1
Raine, T1
Sebastian, S1
de Sousa, HT1
Dignass, A1
Carbonnel, F1
Eriksson, C1
Cao, Y1
Rundquist, S1
Zhulina, Y1
Henriksson, I1
Montgomery, S1
Halfvarson, J1
Cuomo, A1
Sgambato, D1
D'Auria, MV1
Miranda, A1
Ferrante, E1
Romano, M1
Kato, S1
Ishibashi, A1
Kani, K1
Yakabi, K1
Neshta, V1
Pesegova, M1
Alekseeva, O1
Lozynskyy, Y1
Soloviev, K1
Dorofeyev, AE2
Stiess, M1
Liu, Z1
Huang, S1
Chen, Z1
Wang, X1
Yetto, T1
Burns, C1
León-Rendón, JL1
Jiménez-Bobadilla, B1
López-Pérez, RY1
Gracida-Mancilla, NI1
Alarcón-Bernés, L1
Villanueva Herrero, JA1
Seibold, F1
Fournier, N1
Beglinger, C1
Mottet, C1
Pittet, V1
Rogler, G1
Watanabe, M1
Nishino, H1
Sameshima, Y1
Ota, A1
Nakamura, S1
Hibi, T1
Andersson, P1
Norblad, R1
Söderholm, JD1
Myrelid, P1
Park, SK1
Ye, BD1
Yang, SK1
Kim, SO1
Kim, J1
Kim, JW2
Park, SH2
Yang, DH1
Jung, KW1
Kim, KJ1
Byeon, JS1
Myung, SJ1
Kim, JH1
Gecse, KB1
Lakatos, PL2
Actis, GC1
Pellicano, R1
Rosina, F1
Hernández Martínez, A1
Lázaro Sáez, M1
Bendezú García, RA1
Patrón Román, GO1
Kaye, TL1
O'Connor, A1
Burke, D1
Tolan, DJ1
Yamamoto, T2
Shimoyama, T2
Matsumoto, K2
Navas-López, VM1
Blasco-Alonso, J1
Girón Fernández-Crehuet, F1
Serrano Nieto, MJ1
Gallego-Gutiérrez, S1
Luque Pérez, S1
Sierra Salinas, C1
Sun, S1
Cavey, T1
Peltier, L1
Bendavid, C1
Bouguen, G1
Bosworth, BP1
Rubin, DT1
Harper, JR1
Cortot, A1
Maetz, D1
Degoutte, E1
Delette, O1
Meunier, P1
Tan, G1
Cazals, JB1
Dewit, O1
Hebuterne, X1
Beorchia, S1
Grunberg, B1
Leprince, E1
D'Haens, G1
Forestier, S1
Idier, I1
Lémann, M1
Bernal-Sprekelsen, JC1
de las Marinas, MD1
Salvador, A1
Landete, FJ1
Morera, FJ1
Andus, T1
Kocjan, A1
Müser, M1
Baranovsky, A1
Mikhailova, TL1
Zvyagintseva, TD1
Lozynskyy, YS1
Cascorbi, I1
Stolte, M1
Dilger, K1
Munkholm, P1
Michetti, P1
Probert, CS1
Elkjaer, M1
Marteau, P3
Lamet, M2
Heyman, MB1
Kierkus, J1
Spénard, J2
Shbaklo, H1
Giguere, M1
Seo, EH1
Kim, TO1
Kim, TG1
Joo, HR1
Park, J1
Yang, SY1
Moon, YS1
Park, MJ1
Ryu, DY1
Song, GA1
Burger, D1
Travis, S1
Richter, JM1
Kushkuley, S1
Barrett, JA1
Oster, G1
Criscuoli, V1
Rizzuto, MR1
Cottone, M1
Domènech, E1
Gisbert, JP1
Zembrzuska, H1
Ally, MR1
Goldberg, ME1
Watson, J1
Veerappan, GR1
Horwhat, JD1
Herberhold, C1
Folwaczny, C1
Sanguineti, G1
Franzone, P1
Marcenaro, M1
Foppiano, F1
Vitale, V1
Sinha, A1
Nightingale, J1
West, KP1
Berlanga-Acosta, J1
Playford, RJ1
Farrell, RJ1
Ptak, T1
Dallaire, C1
Shah, U1
Grace, M1
de Montigny, D1
Kane, S1
Seo, GS1
Choi, SC1
Jo, EY1
Choi, CS1
Kim, TH1
Yun, KJ1
Nah, YH1
Korkut, C1
Asoglu, O1
Aksoy, M1
Kapran, Y1
Bilge, H1
Kiremit-Korkut, N1
Parlak, M1
Regueiro, M2
Loftus, EV2
Steinhart, AH2
Cohen, RD3
Lakatos, L1
Guslandi, M1
Giollo, P1
Testoni, PA1
Declerck, D1
Wallaert, B1
Demarcq-Delerue, G1
Tonnel, AB1
Mantzaris, GJ1
Hatzis, A1
Petraki, K1
Spiliadi, C1
Triantaphyllou, G1
Lucidarme, D1
Foucault, M1
Vautrin, B1
Filoche, B1
Gionchetti, P2
Rizzello, F2
Venturi, A2
Ferretti, M2
Brignola, C2
Miglioli, M2
Campieri, M4
d'Albasio, G1
Paoluzi, P1
Bianchi Porro, G3
Pera, A2
Prantera, C1
Sturniolo, GC2
Peruzzo, S1
Simmonds, NJ1
Millar, AD1
Blake, DR1
Rampton, DS1
Florent, C1
Ardizzone, S1
Doldo, P1
Ranzi, T2
Giglio, LA1
Annese, V1
D'Arienzo, A2
Gaia, E1
Gullini, S1
Riegler, G1
Valentini, M1
Massa, P1
Del Piano, M1
Rossini, F1
Guidetti, CS1
Woseth, DM1
Thisted, RA1
Hanauer, SB1
Zamir, D1
Weizman, J1
Zamir, C1
Fireman, Z1
Weiner, P1
Cavcić, J1
Turcić, J1
Martinac, P1
Jelincić, Z1
Zupancić, B1
Panijan-Pezerović, R1
Unusić, J1
Venkatesh, KS1
Ramanujam, P1
Ngô, Y1
Rambaud, JC1
Chapman, NJ1
Brown, ML1
Phillips, SF1
Tremaine, WJ1
Schroeder, KW1
Dewanjee, MK1
Zinsmeister, AR1
Hadjigogos, K1
Panarese, A1
D'Armiento, FP1
Lancia, C1
Quattrone, P1
Giannattasio, F1
Boscaino, A1
Mazzacca, G1
De Franchis, R1
Brunetti, G1
Barbara, L1
Tytgat, GN1
Fockens, P1
Schotborgh, RH1
Hofer, SO1
Triantafillidis, JK1
Dadioti, P1
Nicolakis, D1
Mericas, E1
Nelis, GF1
Baum, CA1
Biddle, WL1
Miner, PB1
van Hogezand, RA1
van Hees, PA1
van Gorp, JP1
van Lier, HJ1
Bakker, JH1
Wesseling, P1
van Haelst, UJ1
van Tongeren, JH1
Freund, U1
Schölmerich, J1
Siems, H1
Kluge, F1
Schäfer, HE1
Wannenmacher, M1
Sutherland, LR2
Martin, F2
Williams, CN1
Haber, G1
Aquino, JA1
Greer, S1
Robinson, M1
Greenberger, N1
Saibil, F1
Martin, T1
Sparr, J1
Prokipchuk, E1
Borgen, L1

Clinical Trials (6)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Reduction in Length of Hospitalization in Patients With Acute Severe Ulcerative Colitis Treated With Rescue Therapy With Infliximab by the Use of Web-app Constant-Care. One Year Follow-up, Inclusive Colectomy Rate.[NCT04165265]28 participants (Anticipated)Interventional2019-12-03Recruiting
Randomized, Double-blind, Multicentre Study to Compare the Efficacy and Safety of Budesonide Versus Mesalazine Suppository Versus a Combination Therapy of Budesonide/Mesalazine Suppositories in Patients With Acute Ulcerative Proctitis[NCT01966783]Phase 2320 participants (Anticipated)Interventional2013-09-30Completed
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Budesonide Foam (2 mg/25 mL BID for 2 Weeks, Followed by 2 mg/25 mL QD for 4 Weeks) Versus Placebo in Subjects With Active Mild to Moderate Ulc[NCT01008410]Phase 3265 participants (Actual)Interventional2009-11-17Completed
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Budesonide Foam (2 mg/25 mL BID for 2 Weeks, Followed by 2 mg/25 mL QD for 4 Weeks) Versus Placebo in Subjects With Active Mild to Moderate Ulc[NCT01008423]Phase 3281 participants (Actual)Interventional2009-11-20Completed
Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy[NCT00969111]70 participants (Anticipated)Interventional2009-08-31Recruiting
An Expanded Phase II Study of Hypofractionated Dose Intense Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate[NCT01368055]361 participants (Actual)Interventional2011-09-30Active, not recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Percentage of Participants Who Achieved >=3 Point Improvement From Baseline in the MMDAI Total Score Including Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score and MMDAI Endoscopy Subscale at End of Week 6

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method. (NCT01008410)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Budesonide52.6
Placebo37.9

Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices:stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Missing data was imputed using LOCF method. (NCT01008410)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Budesonide46.6
Placebo28.0

Percentage of Participants Who Achieved a Score of 0 for Rectal Bleeding Subscale and a Combined Score of <=2 for Bowel Frequency and Physician's Global Assessment (PGA) in the MMDAI Subscales at End of Week 6

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Bowel frequency (BF) subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal disease and 3 indicated severe disease. Missing data was imputed using LOCF method. (NCT01008410)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Budesonide41.4
Placebo25.8

Percentage of Participants Who Achieved an Endoscopy MMDAI Subscale Score of 0 or 1 at End of Week 6

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Endoscopy subscale ranged from 0-3, where 0 = normal or inactive disease, 1 = mild disease, 2 = moderate disease and 3 = severe disease (spontaneous bleeding, ulceration). Percentage of participants with normal or mild disease have been presented in this outcome measure. Missing data was imputed using LOCF method. (NCT01008410)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Budesonide55.6
Placebo43.2

Percentage of Participants Who Achieved an MMDAI Total Score of <= 3 With Greater Than or Equal to (>=2) Points of Improvement From Baseline at the End of Week 6

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. Physician global assessment (PGA) subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method. (NCT01008410)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Budesonide45.9
Placebo30.3

Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Endoscopy Subscale Score at End of Week 6

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Endoscopy subscore ranged from 0-3, where 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern), 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 = severe disease (spontaneous bleeding, ulceration). Missing data was imputed using LOCF method. (NCT01008410)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Budesonide57.1
Placebo47.7

Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score at End of Week 6

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, and 3 indicated blood alone passed. Missing data was imputed using LOCF method. (NCT01008410)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Budesonide70.7
Placebo53.0

Percentage of Participants Who Achieved Remission

Remission was a combined assessment of clinical and endoscopic variables, defined as an endoscopy score of less than or equal to (<=) 1, a rectal bleeding score of 0, and an improvement or no change from baseline in stool frequency subscales of the Modified Mayo Disease Activity Index (MMDAI) at the end of 6 weeks of treatment. MMDAI was used to assess the overall disease activity for each participant. MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment (PGA) and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Stool frequency MMDAI subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Endoscopy MMDAI subscore ranged from 0-3, where 0 indicated normal or inactive disease and 3 indicated severe disease (spontaneous bleeding, ulceration). (NCT01008410)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Budesonide38.3
Placebo25.8

Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method. (NCT01008410)
Timeframe: Baseline, Week 6

,
Interventionunit on a scale (Mean)
Bowel frequency score: BaselineBowel frequency score: Change at Week 6Rectal Bleeding score:BaselineRectal Bleeding score: Change at Week 6PGA score:BaselinePGA score: Change at Week 6Endoscopy score:BaselineEndoscopy score: Change at Week 6Total score:BaselineTotal score: Change at Week 6
Budesonide1.8-0.72.1-1.21.8-0.82.1-0.87.8-3.5
Placebo1.9-0.52.1-0.81.8-0.52.1-0.57.9-2.4

Number of Scheduled Assessments With Rectal Bleeding Responder Classification

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Percentage of participants who were rectal bleeding responder at scheduled assessments were reported. Rectal bleeding responders were defined as those participants who achieved a rectal bleeding MMDAI subscale score of 0 during the treatment period. Missing data was imputed using LOCF method. (NCT01008410)
Timeframe: Weeks 1, 2, 4, and 6

,
Interventionpercentage of participants (Number)
Responder at 1 AssessmentResponder at 2 AssessmentResponder at 3 AssessmentResponder at 4 Assessment
Budesonide12.018.821.16.0
Placebo13.613.610.61.5

Percentage of Participants Who Achieved >=3 Point Improvement From Baseline in the MMDAI Total Score Including Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score and MMDAI Endoscopy Subscale at End of Week 6

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method. (NCT01008423)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Budesonide53.7
Placebo34.0

Percentage of Participants Who Achieved a Rectal Bleeding MMDAI Subscale Score of 0 at End of Week 6

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices:stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Missing data was imputed using LOCF method. (NCT01008423)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Budesonide50.0
Placebo28.6

Percentage of Participants Who Achieved a Score of 0 for Rectal Bleeding Subscale and a Combined Score of <=2 for Bowel Frequency (BF) and Physician's Global Assessment (PGA) in the MMDAI Subscales at End of Week 6

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal disease and 3 indicated severe disease. Missing data was imputed using LOCF method. (NCT01008423)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Budesonide46.3
Placebo23.8

Percentage of Participants Who Achieved an Endoscopy MMDAI Subscale Score of 0 or 1 at End of Week 6

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Endoscopy subscale ranged from 0-3, where 0 = normal or inactive disease, 1 = mild disease, 2 = moderate disease and 3 = severe disease (spontaneous bleeding, ulceration). Percentage of participants with normal or mild disease have been presented in this outcome measure. Missing data was imputed using LOCF method. (NCT01008423)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Budesonide56.0
Placebo36.7

Percentage of Participants Who Achieved an MMDAI Total Score of <= 3 With Greater Than or Equal to (>=2) Points of Improvement From Baseline at the End of Week 6

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method. (NCT01008423)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Budesonide49.3
Placebo28.6

Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Endoscopy Subscale Score at End of Week 6

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Endoscopy subscore ranged from 0-3, where 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern), 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 = severe disease (spontaneous bleeding, ulceration). Missing data was imputed using LOCF method. (NCT01008423)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Budesonide57.5
Placebo38.8

Percentage of Participants Who Achieved Improvement of >=1 Point From Baseline in the MMDAI Rectal Bleeding Subscale Score at End of Week 6

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, and 3 indicated blood alone passed. Missing data was imputed using LOCF method. (NCT01008423)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Budesonide72.4
Placebo56.5

Percentage of Participants Who Achieved Remission

Remission was a combined assessment of clinical and endoscopic variables, defined as an endoscopy score of less than or equal to (<=) 1, a rectal bleeding score of 0, and an improvement or no change from baseline in stool frequency subscales of the Modified Mayo Disease Activity Index (MMDAI) at the end of 6 weeks of treatment. MMDAI was used to assess the overall disease activity for each participant. MMDAI evaluated 4 indices: stool frequency, rectal bleeding, physician's global assessment (PGA) and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Stool frequency MMDAI subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Endoscopy MMDAI subscore ranged from 0-3, where 0 indicated normal or inactive disease and 3 indicated severe disease (spontaneous bleeding, ulceration). (NCT01008423)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Budesonide44.0
Placebo22.4

Mean Change From Baseline to Week 6 in MMDAI Total Score and Subscale Scores

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. BF subscore ranged from 0-3, where 0 indicated normal number of stools per day and 3 indicated 5 or more stools than normal. PGA subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. Endoscopy subscore ranged from 0-3, where 0 indicated normal and 3 indicated severe disease. MMDAI total score ranged from 0-12, where higher score indicated severe disease. Missing data was imputed using LOCF method. (NCT01008423)
Timeframe: Baseline, Week 6

,
Interventionunit on a scale (Mean)
Bowel frequency score: BaselineBowel frequency score: Change at Week 6Rectal Bleeding score:BaselineRectal Bleeding score: Change at Week 6PGA score:BaselinePGA score: Change at Week 6Endoscopy score:BaselineEndoscopy score: Change at Week 6Total score:BaselineTotal score: Change at Week 6
Budesonide1.7-0.82.1-1.32.0-0.92.1-0.97.9-3.8
Placebo1.8-0.52.1-0.92.0-0.62.1-0.58.0-2.5

Number of Scheduled Assessments With Rectal Bleeding Responder Classification

The MMDAI was used to assess the overall disease activity for each participant. The MMDAI evaluated 4 indices: stool frequency, rectal bleeding, PGA and endoscopy findings each on a scale of 0 to 3 with a maximum total score of 12. Rectal bleeding MMDAI subscore ranged from 0-3, where 0 indicated no blood seen and 3 indicated blood alone passed. Percentage of participants who were rectal bleeding responder at scheduled assessments were reported. Rectal bleeding responders were defined as those participants who achieved a rectal bleeding MMDAI subscale score of 0 during the treatment period. Missing data was imputed using LOCF method. (NCT01008423)
Timeframe: Weeks 1, 2, 4, and 6

,
Interventionpercentage of participants (Number)
Responder at 1 assessmentResponder at 2 assessmentResponder at 3 assessmentResponder at 4 assessment
Budesonide8.216.421.613.4
Placebo18.417.07.52.0

Reviews

12 reviews available for mesalamine and Proctitis

ArticleYear
Efficacy of Pharmacological Agents for Ulcerative Proctitis: A Systematic Literature Review.
    Journal of Crohn's & colitis, 2022, Jul-14, Volume: 16, Issue:6

    Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Humans; Mesalamine; Observation

2022
Systematic review with meta-analysis: Medical therapies for treatment of ulcerative proctitis.
    Alimentary pharmacology & therapeutics, 2023, Volume: 58, Issue:8

    Topics: Administration, Oral; Adult; Anti-Inflammatory Agents, Non-Steroidal; Budesonide; Colitis, Ulcerativ

2023
Drug development for ulcerative proctitis: current concepts.
    Gut, 2021, Volume: 70, Issue:7

    Topics: Administration, Oral; Administration, Rectal; Adrenal Cortex Hormones; Anti-Inflammatory Agents; Ant

2021
Optimized Management of Ulcerative Proctitis: When and How to Use Mesalazine Suppository.
    Digestion, 2018, Volume: 97, Issue:1

    Topics: Administration, Topical; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Consensus; Di

2018
Ulcerative proctitis: an update on the pharmacotherapy and management.
    Expert opinion on pharmacotherapy, 2014, Volume: 15, Issue:11

    Topics: Anti-Inflammatory Agents; Colitis, Ulcerative; Disease Management; Humans; Mesalamine; Prednisolone;

2014
A young woman with recurrent perianal sepsis.
    BMJ (Clinical research ed.), 2015, Apr-23, Volume: 350

    Topics: Abscess; Adult; Anti-Inflammatory Agents, Non-Steroidal; Crohn Disease; Drainage; Female; Humans; Ma

2015
Best practice in the management of mild-to-moderately active ulcerative colitis and achieving maintenance of remission using mesalazine.
    European journal of gastroenterology & hepatology, 2010, Volume: 22, Issue:8

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Health Care Costs; Humans; Mesalamine;

2010
Conventional medical management of inflammatory bowel disease.
    Gastroenterology, 2011, Volume: 140, Issue:6

    Topics: Adrenal Cortex Hormones; Algorithms; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroid

2011
Medical management of left-sided ulcerative colitis and ulcerative proctitis: critical evaluation of therapeutic trials.
    Inflammatory bowel diseases, 2006, Volume: 12, Issue:10

    Topics: Adrenal Cortex Hormones; Anti-Bacterial Agents; Anti-Inflammatory Agents; Anti-Inflammatory Agents,

2006
Ulcerative proctitis: a review of pharmacotherapy and management.
    Expert opinion on pharmacotherapy, 2008, Volume: 9, Issue:5

    Topics: Administration, Oral; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Controlled Clini

2008
A meta-analysis and overview of the literature on treatment options for left-sided ulcerative colitis and ulcerative proctitis.
    The American journal of gastroenterology, 2000, Volume: 95, Issue:5

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Glucocorticoids; Humans; Mesalamine; P

2000
Proctitis.
    The Netherlands journal of medicine, 1990, Volume: 37 Suppl 1

    Topics: Aminosalicylic Acids; Barium Sulfate; Crohn Disease; Diagnosis, Differential; Enema; Humans; Mesalam

1990

Trials

29 trials available for mesalamine and Proctitis

ArticleYear
Novel Budesonide Suppository and Standard Budesonide Rectal Foam Induce High Rates of Clinical Remission and Mucosal Healing in Active Ulcerative Proctitis: a Randomised, Controlled, Non-inferiority Trial.
    Journal of Crohn's & colitis, 2022, Nov-23, Volume: 16, Issue:11

    Topics: Budesonide; Colitis, Ulcerative; Double-Blind Method; Humans; Mesalamine; Proctitis; Quality of Life

2022
No Superiority of Tacrolimus Suppositories vs Beclomethasone Suppositories in a Randomized Trial of Patients With Refractory Ulcerative Proctitis.
    Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2020, Volume: 18, Issue:8

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Beclomethasone; Colitis, Ulcerative; Female; Humans; Male;

2020
Budesonide Suppositories Are Effective and Safe for Treating Acute Ulcerative Proctitis.
    Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2019, Volume: 17, Issue:1

    Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents; Budesonide; Colitis, Ulcerative; Double-Blind Met

2019
Randomised clinical trial: evaluation of the efficacy of mesalazine (mesalamine) suppositories in patients with ulcerative colitis and active rectal inflammation -- a placebo-controlled study.
    Alimentary pharmacology & therapeutics, 2013, Volume: 38, Issue:3

    Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Asian People; Colitis, Ulcerative;

2013
Baseline Oral 5-ASA Use and Efficacy and Safety of Budesonide Foam in Patients with Ulcerative Proctitis and Ulcerative Proctosigmoiditis: Analysis of 2 Phase 3 Studies.
    Inflammatory bowel diseases, 2016, Volume: 22, Issue:8

    Topics: Administration, Oral; Administration, Rectal; Adult; Anti-Inflammatory Agents, Non-Steroidal; Budeso

2016
Baseline Oral 5-ASA Use and Efficacy and Safety of Budesonide Foam in Patients with Ulcerative Proctitis and Ulcerative Proctosigmoiditis: Analysis of 2 Phase 3 Studies.
    Inflammatory bowel diseases, 2016, Volume: 22, Issue:8

    Topics: Administration, Oral; Administration, Rectal; Adult; Anti-Inflammatory Agents, Non-Steroidal; Budeso

2016
Baseline Oral 5-ASA Use and Efficacy and Safety of Budesonide Foam in Patients with Ulcerative Proctitis and Ulcerative Proctosigmoiditis: Analysis of 2 Phase 3 Studies.
    Inflammatory bowel diseases, 2016, Volume: 22, Issue:8

    Topics: Administration, Oral; Administration, Rectal; Adult; Anti-Inflammatory Agents, Non-Steroidal; Budeso

2016
Baseline Oral 5-ASA Use and Efficacy and Safety of Budesonide Foam in Patients with Ulcerative Proctitis and Ulcerative Proctosigmoiditis: Analysis of 2 Phase 3 Studies.
    Inflammatory bowel diseases, 2016, Volume: 22, Issue:8

    Topics: Administration, Oral; Administration, Rectal; Adult; Anti-Inflammatory Agents, Non-Steroidal; Budeso

2016
Mesalamine foam enema versus mesalamine liquid enema in active left-sided ulcerative colitis.
    The American journal of gastroenterology, 2008, Volume: 103, Issue:12

    Topics: Administration, Rectal; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-St

2008
Clinical trial: a novel high-dose 1 g mesalamine suppository (Salofalk) once daily is as efficacious as a 500-mg suppository thrice daily in active ulcerative proctitis.
    Inflammatory bowel diseases, 2010, Volume: 16, Issue:11

    Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Drug Administ

2010
A multicenter, randomized study to evaluate the efficacy and safety of mesalamine suppositories 1 g at bedtime and 500 mg Twice daily in patients with active mild-to-moderate ulcerative proctitis.
    Digestive diseases and sciences, 2011, Volume: 56, Issue:2

    Topics: Adolescent; Adult; Aged; Dose-Response Relationship, Drug; Female; Humans; Male; Mesalamine; Middle

2011
Efficacy and safety of mesalamine suppositories for treatment of ulcerative proctitis in children and adolescents.
    Inflammatory bowel diseases, 2010, Volume: 16, Issue:11

    Topics: Adolescent; Anti-Inflammatory Agents, Non-Steroidal; Child; Child, Preschool; Colitis, Ulcerative; F

2010
Sucralfate versus mesalazine versus hydrocortisone in the prevention of acute radiation proctitis during conformal radiotherapy for prostate carcinoma. A randomized study.
    Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al], 2003, Volume: 179, Issue:7

    Topics: Acute Disease; Aged; Aged, 80 and over; Contraindications; Data Interpretation, Statistical; Dose Fr

2003
Epidermal growth factor enemas with oral mesalamine for mild-to-moderate left-sided ulcerative colitis or proctitis.
    The New England journal of medicine, 2003, Jul-24, Volume: 349, Issue:4

    Topics: Administration, Oral; Adult; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Double-Bl

2003
Efficacy and safety of mesalamine 1 g HS versus 500 mg BID suppositories in mild to moderate ulcerative proctitis: a multicenter randomized study.
    Inflammatory bowel diseases, 2005, Volume: 11, Issue:7

    Topics: Adult; Aged; Analysis of Variance; Anti-Inflammatory Agents, Non-Steroidal; Drug Administration Sche

2005
Intermittent therapy with high-dose 5-aminosalicylic acid enemas maintains remission in ulcerative proctitis and proctosigmoiditis.
    Diseases of the colon and rectum, 1994, Volume: 37, Issue:1

    Topics: Administration, Oral; Administration, Rectal; Adolescent; Adult; Aged; Aminosalicylic Acids; Colitis

1994
Efficacy and tolerance of mesalazine suppositories vs. hydrocortisone foam in proctitis.
    Alimentary pharmacology & therapeutics, 1997, Volume: 11, Issue:2

    Topics: Acute Disease; Administration, Topical; Adult; Aminosalicylic Acids; Anti-Inflammatory Agents; Anti-

1997
Comparison of oral with rectal mesalazine in the treatment of ulcerative proctitis.
    Diseases of the colon and rectum, 1998, Volume: 41, Issue:1

    Topics: Administration, Oral; Administration, Rectal; Adult; Colitis, Ulcerative; Female; Humans; Male; Mesa

1998
Maintenance treatment of ulcerative proctitis with mesalazine suppositories: a double-blind placebo-controlled trial. The Italian IBD Study Group.
    The American journal of gastroenterology, 1998, Volume: 93, Issue:5

    Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Dose-Response Relationship, Drug;

1998
Comparison of mesalazine suppositories in proctitis and distal proctosigmoiditis.
    Alimentary pharmacology & therapeutics, 1997, Volume: 11, Issue:6

    Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Drug Administration Schedule; Female; Humans; Male;

1997
Comparative, open, randomized trial of the efficacy and tolerance of slow-release 5-ASA suppositories once daily versus conventional 5-ASA suppositories twice daily in the treatment of active cryptogenic proctitis: French Pentasa Study Group.
    The American journal of gastroenterology, 2000, Volume: 95, Issue:1

    Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Delayed-Action Preparations; Drug Administration Sch

2000
Mesalazine foam (Salofalk foam) in the treatment of active distal ulcerative colitis. A comparative trial vs Salofalk enema. The SAF-3 study group.
    Italian journal of gastroenterology and hepatology, 1999, Volume: 31, Issue:8

    Topics: Administration, Topical; Adult; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Cross-

1999
Metronidazole in the treatment of chronic radiation proctitis: clinical trial.
    Croatian medical journal, 2000, Volume: 41, Issue:3

    Topics: Aged; Anti-Infective Agents; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Beta

2000
Metronidazole in the treatment of chronic radiation proctitis: clinical trial.
    Croatian medical journal, 2000, Volume: 41, Issue:3

    Topics: Aged; Anti-Infective Agents; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Beta

2000
Metronidazole in the treatment of chronic radiation proctitis: clinical trial.
    Croatian medical journal, 2000, Volume: 41, Issue:3

    Topics: Aged; Anti-Infective Agents; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Beta

2000
Metronidazole in the treatment of chronic radiation proctitis: clinical trial.
    Croatian medical journal, 2000, Volume: 41, Issue:3

    Topics: Aged; Anti-Infective Agents; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Beta

2000
[5-aminosalicylic acid enema (Pentasa) versus hydrocortisone acetate foam (Proctocort) for the treatment of outbreaks of proctitis and cryptogenetic proctosigmoiditis. A comparative randomized multicenter trial].
    Gastroenterologie clinique et biologique, 1992, Volume: 16, Issue:6-7

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Aminosalicylic Acids; Enema; Female; Humans; Hydrocortis

1992
5-Aminosalicylic acid suppositories in the maintenance of remission in idiopathic proctitis or proctosigmoiditis: a double-blind placebo-controlled clinical trial.
    The American journal of gastroenterology, 1990, Volume: 85, Issue:9

    Topics: Administration, Rectal; Adult; Aminosalicylic Acids; Colitis, Ulcerative; Double-Blind Method; Drug

1990
Mesalazine (5-aminosalicylic acid) suppositories in the treatment of ulcerative proctitis or distal proctosigmoiditis. A randomized controlled trial.
    Scandinavian journal of gastroenterology, 1990, Volume: 25, Issue:7

    Topics: Adult; Aminosalicylic Acids; Colitis; Double-Blind Method; Female; Humans; Male; Mesalamine; Multice

1990
Double-blind comparison of 5-aminosalicylic acid and acetyl-5-aminosalicylic acid suppositories in patients with idiopathic proctitis.
    Alimentary pharmacology & therapeutics, 1988, Volume: 2, Issue:1

    Topics: Adult; Aminosalicylic Acids; Double-Blind Method; Female; Humans; Male; Mesalamine; Proctitis; Suppo

1988
Mesalamine for ulcerative colitis.
    The Medical letter on drugs and therapeutics, 1988, May-20, Volume: 30, Issue:766

    Topics: Aminosalicylic Acids; Clinical Trials as Topic; Colitis, Ulcerative; Dose-Response Relationship, Dru

1988
[Unwanted side-effects in using mesalazine (5-aminosalicylic acid) during radiotherapy].
    Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al], 1987, Volume: 163, Issue:10

    Topics: Aged; Aged, 80 and over; Aminosalicylic Acids; Clinical Trials as Topic; Double-Blind Method; Humans

1987
5-Aminosalicylic acid enemas in treatment of distal ulcerative colitis and proctitis in Canada.
    Digestive diseases and sciences, 1987, Volume: 32, Issue:12 Suppl

    Topics: Adult; Aminosalicylic Acids; Canada; Clinical Trials as Topic; Colitis, Ulcerative; Double-Blind Met

1987
Double-blind, placebo-controlled evaluation of 5-ASA suppositories in active distal proctitis and measurement of extent of spread using 99mTc-labeled 5-ASA suppositories.
    Digestive diseases and sciences, 1987, Volume: 32, Issue:12 Suppl

    Topics: Administration, Rectal; Adult; Aminosalicylic Acids; Clinical Trials as Topic; Double-Blind Method;

1987
5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis.
    Gastroenterology, 1987, Volume: 92, Issue:6

    Topics: Adult; Aminosalicylic Acids; Colitis; Colitis, Ulcerative; Enema; Female; Humans; Male; Mesalamine;

1987

Other Studies

41 other studies available for mesalamine and Proctitis

ArticleYear
Evaluation of mesalazine polymeric conjugate in the treatment of actinic proctitis in rats.
    Acta cirurgica brasileira, 2021, Volume: 36, Issue:8

    Topics: Administration, Oral; Animals; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Female;

2021
Ulcerative proctitis: Challenges for clinical management.
    Journal of gastroenterology and hepatology, 2023, Volume: 38, Issue:7

    Topics: Colitis, Ulcerative; Humans; Mesalamine; Proctitis

2023
Long-term outcomes of patients with ulcerative proctitis: Analysis from a large referral centre cohort.
    United European gastroenterology journal, 2020, Volume: 8, Issue:8

    Topics: Adult; Anti-Inflammatory Agents; Azathioprine; Biological Factors; Colitis, Ulcerative; Drug Resista

2020
Long-term outcome of ulcerative proctitis.
    United European gastroenterology journal, 2020, Volume: 8, Issue:8

    Topics: Cohort Studies; Colitis, Ulcerative; Humans; Mesalamine; Proctitis; Referral and Consultation

2020
Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management.
    Journal of Crohn's & colitis, 2017, 07-01, Volume: 11, Issue:7

    Topics: Adrenal Cortex Hormones; Anti-Inflammatory Agents, Non-Steroidal; Biological Products; Colitis, Ulce

2017
Changes in medical management and colectomy rates: a population-based cohort study on the epidemiology and natural history of ulcerative colitis in Örebro, Sweden, 1963-2010.
    Alimentary pharmacology & therapeutics, 2017, Volume: 46, Issue:8

    Topics: Adolescent; Adult; Cohort Studies; Colectomy; Colitis, Ulcerative; Disease Progression; Female; Huma

2017
Multi Matrix System Mesalazine Plus Rectal Mesalazine in the Treatment of Mild to Moderately Active Ulcerative Proctitis.
    Digestive diseases (Basel, Switzerland), 2018, Volume: 36, Issue:2

    Topics: Adolescent; Adult; Aged; Colitis, Ulcerative; Female; Humans; Male; Mesalamine; Middle Aged; Proctit

2018
Effects of mesalazine enemas on lymphoid follicular proctitis.
    Revista espanola de enfermedades digestivas, 2018, Volume: 110, Issue:9

    Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Colonoscopy; Endoscopy, Gastrointestinal; Enema; Hum

2018
Linear IgA bullous dermatosis associated with ulcerative proctitis: treatment challenge.
    Dermatology online journal, 2018, Jul-15, Volume: 24, Issue:7

    Topics: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Humans; Immu

2018
Ulcerative colitis: epidemiology, clinical features and associated factors with surgical treatment in a tertiary hospital in Mexico.
    Cirugia y cirujanos, 2019, Volume: 87, Issue:4

    Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Female; Humans; Incidence

2019
Topical therapy is underused in patients with ulcerative colitis.
    Journal of Crohn's & colitis, 2014, Volume: 8, Issue:1

    Topics: Administration, Oral; Administration, Rectal; Administration, Topical; Adolescent; Adrenal Cortex Ho

2014
Ileorectal anastomosis in comparison with ileal pouch anal anastomosis in reconstructive surgery for ulcerative colitis--a single institution experience.
    Journal of Crohn's & colitis, 2014, Volume: 8, Issue:7

    Topics: Abdominal Neoplasms; Adenocarcinoma; Adolescent; Adrenal Cortex Hormones; Adult; Anastomosis, Surgic

2014
Clinical features and course of ulcerative colitis diagnosed in asymptomatic subjects.
    Journal of Crohn's & colitis, 2014, Volume: 8, Issue:10

    Topics: Adrenal Cortex Hormones; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Asymptomatic Diseases

2014
Ulcerative proctitis in out-patient practice: an unexpected clinical challenge.
    Minerva gastroenterologica e dietologica, 2014, Volume: 60, Issue:3

    Topics: Adult; Aged; Aged, 80 and over; Ambulatory Care; Anti-Inflammatory Agents, Non-Steroidal; Beclometha

2014
[Chemical proctitis due to ergotamine: «not always an ulcerative colitis»].
    Gastroenterologia y hepatologia, 2015, Volume: 38, Issue:8

    Topics: Acetaminophen; Aged; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Diagnosis, Differ

2015
Consecutive monitoring of faecal calprotectin during mesalazine suppository therapy for active rectal inflammation in ulcerative colitis.
    Alimentary pharmacology & therapeutics, 2015, Volume: 42, Issue:5

    Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Biomarkers; Colitis, Ulcerative; E

2015
Successful treatment for ulcerative proctitis with rectal tacrolimus in an 8-year-old girl with intolerance to mesalamine.
    Clinical journal of gastroenterology, 2014, Volume: 7, Issue:4

    Topics: Administration, Rectal; Anti-Inflammatory Agents, Non-Steroidal; Child; Colitis, Ulcerative; Female;

2014
Letter: wide variation in faecal calprotectin values according to the assay.
    Alimentary pharmacology & therapeutics, 2016, Volume: 43, Issue:1

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Female; Humans; Leukocyte L1 Antigen C

2016
Letter: wide variation in faecal calprotectin values according to the assay - authors' reply.
    Alimentary pharmacology & therapeutics, 2016, Volume: 43, Issue:1

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Female; Humans; Leukocyte L1 Antigen C

2016
Recurrent pericarditis in a patient with ulcerative proctitis due to mesalazine suppositories.
    International journal of colorectal disease, 2010, Volume: 25, Issue:9

    Topics: Humans; Male; Mesalamine; Middle Aged; Pericarditis; Proctitis; Radiography, Thoracic; Recurrence; S

2010
The efficacy of the combination therapy with oral and topical mesalazine for patients with the first episode of radiation proctitis.
    Digestive diseases and sciences, 2011, Volume: 56, Issue:9

    Topics: Administration, Oral; Administration, Topical; Aged; Anti-Inflammatory Agents, Non-Steroidal; Female

2011
Treatment of new-onset ulcerative colitis and ulcerative proctitis: a retrospective study.
    Alimentary pharmacology & therapeutics, 2012, Volume: 36, Issue:3

    Topics: Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Ster

2012
A rare case of ulcerative proctitis associated with type B lymphomatoid papulosis and superimposed human cytomegalovirus infection.
    International journal of dermatology, 2012, Volume: 51, Issue:7

    Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Cytomegalovirus Infections; Humans; Lymphomatoid Pap

2012
Letter: real-life management of new onset ulcerative colitis and proctitis.
    Alimentary pharmacology & therapeutics, 2012, Volume: 36, Issue:7

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Female; Glucocorticoids; Humans; Male;

2012
Treatment of intractable rectal stump drainage with cryoablation.
    The American journal of gastroenterology, 2012, Volume: 107, Issue:10

    Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Blast Injuries; Buttocks; Colostomy; Cryosurgery; Ex

2012
Ulcerating proctitis in a patient with congenital neutropenia.
    The American journal of gastroenterology, 2003, Volume: 98, Issue:5

    Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Fissure in Ano; Humans; Male; Mesalamine; Neutropeni

2003
Epidermal growth factor for ulcerative colitis.
    The New England journal of medicine, 2003, Jul-24, Volume: 349, Issue:4

    Topics: Administration, Oral; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Drug Therapy, Co

2003
Is non-adherence to blame?
    Inflammatory bowel diseases, 2005, Volume: 11, Issue:7

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Female; Humans; Inflammatory Bowel Diseases; Male; Mesalami

2005
[The usefulness of mesalazine suppositories for the treatment of lymphoid follicular proctitis].
    The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi, 2006, Volume: 47, Issue:6

    Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Female; Humans; Male; Mesalamine; Middle Aged;

2006
Histopathological comparison of topical therapy modalities for acute radiation proctitis in an experimental rat model.
    World journal of gastroenterology, 2006, Aug-14, Volume: 12, Issue:30

    Topics: Administration, Topical; Animals; Anti-Inflammatory Agents; Anti-Ulcer Agents; Betamethasone; Diseas

2006
Clinical guidelines for the medical management of left-sided ulcerative colitis and ulcerative proctitis: summary statement.
    Inflammatory bowel diseases, 2006, Volume: 12, Issue:10

    Topics: Adrenal Cortex Hormones; Algorithms; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; D

2006
A combination of rectal beclomethasone diproprionate and mesalazine in ulcerative proctitis.
    Scandinavian journal of gastroenterology, 2008, Volume: 43, Issue:5

    Topics: Administration, Oral; Adult; Anti-Inflammatory Agents, Non-Steroidal; Beclomethasone; Drug Therapy,

2008
[Iatrogenic diffuse interstitial pneumonia linked to 5-aminosalicylate].
    Revue des maladies respiratoires, 1994, Volume: 11, Issue:3

    Topics: Aminosalicylic Acids; Colitis; Drug Therapy, Combination; Female; Gastrointestinal Hemorrhage; Human

1994
Antioxidant effects of aminosalicylates and potential new drugs for inflammatory bowel disease: assessment in cell-free systems and inflamed human colorectal biopsies.
    Alimentary pharmacology & therapeutics, 1999, Volume: 13, Issue:3

    Topics: Adrenal Cortex Hormones; Adult; Aged; Aminosalicylic Acid; Aminosalicylic Acids; Anti-Infective Agen

1999
[Mesalamine-induced hypersensitivity pneumonitis].
    Harefuah, 1999, Volume: 137, Issue:1-2

    Topics: Adrenal Cortex Hormones; Adult; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Drug H

1999
Endoscopic therapy for radiation proctitis-induced hemorrhage in patients with prostatic carcinoma using argon plasma coagulator application.
    Surgical endoscopy, 2002, Volume: 16, Issue:4

    Topics: Administration, Oral; Administration, Rectal; Administration, Topical; Aged; Aged, 80 and over; Anti

2002
Distribution of mesalamine enemas in patients with active distal ulcerative colitis.
    Mayo Clinic proceedings, 1992, Volume: 67, Issue:3

    Topics: Adolescent; Adult; Aminosalicylic Acids; Colitis, Ulcerative; Colon, Sigmoid; Enema; Female; Humans;

1992
Unusual side effects of mesalazine.
    The Italian journal of gastroenterology, 1991, Volume: 23, Issue:5

    Topics: Adult; Alopecia; Aminosalicylic Acids; Female; Humans; Mesalamine; Proctitis

1991
High doses of 5-aminosalicylic acid enemas in chronic radiation proctitis: comparison with betamethasone enemas.
    The American journal of gastroenterology, 1990, Volume: 85, Issue:11

    Topics: Adult; Aged; Aminosalicylic Acids; Betamethasone; Chronic Disease; Enema; Female; Humans; Mesalamine

1990
Diarrhoea due to 5-aminosalicylic acid in breast milk.
    Lancet (London, England), 1989, Feb-18, Volume: 1, Issue:8634

    Topics: Adult; Aminosalicylic Acids; Breast Feeding; Diarrhea, Infantile; Female; Humans; Infant; Mesalamine

1989
Failure of 5-aminosalicylic acid enemas to improve chronic radiation proctitis.
    Digestive diseases and sciences, 1989, Volume: 34, Issue:5

    Topics: Aminosalicylic Acids; Chronic Disease; Drug Evaluation; Enema; Female; Humans; Male; Mesalamine; Pro

1989