mesalamine has been researched along with Proctocolitis in 36 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.
Proctocolitis: Inflammation of the RECTUM and the distal portion of the COLON.
| Excerpt | Relevance | Reference |
|---|---|---|
| "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) |
| "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) |
| " The frequency of adverse events was comparable between groups, regardless of baseline 5-ASA use." | 2.82 | 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. ( Bosworth, BP; Harper, JR; Rubin, DT; Sandborn, WJ, 2016) |
| "Balsalazide is a new-generation 5-ASA drug that yields a high concentration of active drug to the distal colon." | 2.71 | Prevention of acute radiation-induced proctosigmoiditis by balsalazide: a randomized, double-blind, placebo controlled trial in prostate cancer patients. ( Bettenhausen, D; Jahraus, CD; Malik, U; Sellitti, M; St Clair, WH, 2005) |
| " No dose-response relation was demonstrated." | 2.69 | Dose-ranging study of mesalamine (PENTASA) enemas in the treatment of acute ulcerative proctosigmoiditis: results of a multicentered placebo-controlled trial. The U.S. PENTASA Enema Study Group. ( Hanauer, SB, 1998) |
| "b." | 2.67 | Short-chain fatty acid enemas: a cost-effective alternative in the treatment of nonspecific proctosigmoiditis. ( Ebrom, JS; MacKeigan, JM; Scheider, M; Senagore, AJ, 1992) |
| "The same drugs are used to treat hemorrhagic rectocolitis (HRC) and Crohn's disease (CD), although the aims are very different." | 2.44 | [Treatment of chronic inflammatory bowel diseases]. ( Lémann, M, 2007) |
| "Distal ulcerative colitis (UC) is responsible for distressing symptoms and reduces quality of life (QoL)." | 1.72 | Real-world evidence of quality of life improvement in patients with distal ulcerative colitis treated by mesalazine: the Quartz study. ( Caron, B; Gonzalez, F; Paupard, T; Peyrin-Biroulet, L; Siproudhis, L, 2022) |
| "Organizing pneumonia is a rare extra-intestinal manifestation of UC." | 1.40 | [Organizing pneumonia during treatment with mesalazine]. ( Graffin, B; Michy, B; Raymond, S, 2014) |
| "Mesalazine-induced interstitial nephritis is a rare complication; however, the morbidity in an affected individual is high." | 1.35 | Mesalazine-induced interstitial nephritis. ( Dedek, P; Podhola, M; Pozler, O; Skalova, S, 2009) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 5 (13.89) | 18.7374 |
| 1990's | 11 (30.56) | 18.2507 |
| 2000's | 9 (25.00) | 29.6817 |
| 2010's | 9 (25.00) | 24.3611 |
| 2020's | 2 (5.56) | 2.80 |
| Authors | Studies |
|---|---|
| Paupard, T | 1 |
| Gonzalez, F | 1 |
| Caron, B | 1 |
| Siproudhis, L | 1 |
| Peyrin-Biroulet, L | 1 |
| Dussouillez, G | 1 |
| Zayet, S | 1 |
| Kone, D | 1 |
| Royer, PY | 1 |
| Toko-Tchuindzie, L | 1 |
| Ruyer, O | 1 |
| Gendrin, V | 1 |
| Choi, YS | 1 |
| Kim, WJ | 1 |
| Kim, JK | 1 |
| Kim, DS | 1 |
| Lee, DH | 1 |
| Argyriou, K | 1 |
| Samuel, S | 1 |
| Moran, GW | 1 |
| Yönal, O | 1 |
| Hatemi, G | 1 |
| Kaymakoğlu, S | 1 |
| Michy, B | 1 |
| Raymond, S | 1 |
| Graffin, B | 1 |
| Domínguez Jiménez, JL | 1 |
| Pelado García, EM | 1 |
| Copado Herrera, R | 1 |
| Green, EK | 1 |
| Ambrose, LR | 1 |
| Webster, DP | 1 |
| Atkinson, C | 1 |
| Griffiths, P | 1 |
| Murray, CD | 1 |
| Goodman, AL | 1 |
| Bosworth, BP | 1 |
| Sandborn, WJ | 1 |
| Rubin, DT | 1 |
| Harper, JR | 1 |
| Richter, JM | 1 |
| Arshi, NK | 1 |
| Oster, G | 1 |
| Cortot, A | 1 |
| Maetz, D | 1 |
| Degoutte, E | 1 |
| Delette, O | 1 |
| Meunier, P | 1 |
| Tan, G | 1 |
| Cazals, JB | 1 |
| Dewit, O | 1 |
| Hebuterne, X | 1 |
| Beorchia, S | 1 |
| Grunberg, B | 1 |
| Leprince, E | 1 |
| D'Haens, G | 1 |
| Forestier, S | 1 |
| Idier, I | 1 |
| Lémann, M | 2 |
| Skalova, S | 1 |
| Dedek, P | 1 |
| Pozler, O | 1 |
| Podhola, M | 1 |
| Peltonen, S | 1 |
| Kankuri-Tammilehto, M | 1 |
| Chermesh, I | 1 |
| Eliakim, R | 1 |
| Regueiro, MD | 1 |
| Jahraus, CD | 1 |
| Bettenhausen, D | 1 |
| Malik, U | 1 |
| Sellitti, M | 1 |
| St Clair, WH | 1 |
| Shaffer, JL | 1 |
| Kershaw, A | 1 |
| Berrisford, MH | 1 |
| Karvonen, AL | 1 |
| Matikainen, M | 1 |
| Turunen, U | 1 |
| Beno, I | 1 |
| Staruchová, M | 1 |
| Volkovová, K | 1 |
| Mekinová, D | 1 |
| Bobek, P | 1 |
| Jurcovicová, M | 1 |
| Borum, ML | 1 |
| Ginsberg, A | 1 |
| Hanauer, SB | 1 |
| Gionchetti, P | 1 |
| Rizzello, F | 1 |
| Venturi, A | 1 |
| Brignola, C | 1 |
| Ferretti, M | 1 |
| Peruzzo, S | 1 |
| Campieri, M | 2 |
| Cutrufo, C | 1 |
| Evangelista, S | 1 |
| Cirillo, R | 1 |
| Ciucci, A | 1 |
| Conte, B | 1 |
| Lopez, G | 1 |
| Manzini, S | 1 |
| Maggi, CA | 1 |
| Allgayer, H | 1 |
| Böhne, P | 1 |
| Kruis, W | 1 |
| Ardizzone, S | 1 |
| Doldo, P | 1 |
| Ranzi, T | 2 |
| Sturniolo, GC | 1 |
| Giglio, LA | 1 |
| Annese, V | 1 |
| D'Arienzo, A | 1 |
| Gaia, E | 1 |
| Gullini, S | 1 |
| Riegler, G | 1 |
| Valentini, M | 1 |
| Massa, P | 1 |
| Del Piano, M | 1 |
| Rossini, F | 1 |
| Guidetti, CS | 1 |
| Pera, A | 1 |
| Greinwald, R | 1 |
| Bianchi Porro, G | 2 |
| Bitton, A | 1 |
| Senagore, AJ | 1 |
| MacKeigan, JM | 1 |
| Scheider, M | 1 |
| Ebrom, JS | 1 |
| Ngô, Y | 1 |
| Rambaud, JC | 1 |
| De Franchis, R | 1 |
| Brunetti, G | 1 |
| Barbara, L | 1 |
| Sutherland, LR | 2 |
| Martin, F | 2 |
| McPhee, MS | 1 |
| Swan, JT | 1 |
| Biddle, WL | 1 |
| Greenberger, NJ | 1 |
| Greer, S | 1 |
| Robinson, M | 1 |
| Greenberger, N | 1 |
| Saibil, F | 1 |
| Martin, T | 1 |
| Sparr, J | 1 |
| Prokipchuk, E | 1 |
| Borgen, L | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)[NCT02368743] | 117 participants (Actual) | Observational | 2015-12-31 | Completed | |||
| 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 3 | 265 participants (Actual) | Interventional | 2009-11-17 | Completed | ||
| 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 3 | 281 participants (Actual) | Interventional | 2009-11-20 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
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
| Intervention | percentage of participants (Number) |
|---|---|
| Budesonide | 52.6 |
| Placebo | 37.9 |
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
| Intervention | percentage of participants (Number) |
|---|---|
| Budesonide | 46.6 |
| Placebo | 28.0 |
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
| Intervention | percentage of participants (Number) |
|---|---|
| Budesonide | 41.4 |
| Placebo | 25.8 |
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
| Intervention | percentage of participants (Number) |
|---|---|
| Budesonide | 55.6 |
| Placebo | 43.2 |
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
| Intervention | percentage of participants (Number) |
|---|---|
| Budesonide | 45.9 |
| Placebo | 30.3 |
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
| Intervention | percentage of participants (Number) |
|---|---|
| Budesonide | 57.1 |
| Placebo | 47.7 |
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
| Intervention | percentage of participants (Number) |
|---|---|
| Budesonide | 70.7 |
| Placebo | 53.0 |
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
| Intervention | percentage of participants (Number) |
|---|---|
| Budesonide | 38.3 |
| Placebo | 25.8 |
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
| Intervention | unit on a scale (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Bowel frequency score: Baseline | Bowel frequency score: Change at Week 6 | Rectal Bleeding score:Baseline | Rectal Bleeding score: Change at Week 6 | PGA score:Baseline | PGA score: Change at Week 6 | Endoscopy score:Baseline | Endoscopy score: Change at Week 6 | Total score:Baseline | Total score: Change at Week 6 | |
| Budesonide | 1.8 | -0.7 | 2.1 | -1.2 | 1.8 | -0.8 | 2.1 | -0.8 | 7.8 | -3.5 |
| Placebo | 1.9 | -0.5 | 2.1 | -0.8 | 1.8 | -0.5 | 2.1 | -0.5 | 7.9 | -2.4 |
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
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| Responder at 1 Assessment | Responder at 2 Assessment | Responder at 3 Assessment | Responder at 4 Assessment | |
| Budesonide | 12.0 | 18.8 | 21.1 | 6.0 |
| Placebo | 13.6 | 13.6 | 10.6 | 1.5 |
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
| Intervention | percentage of participants (Number) |
|---|---|
| Budesonide | 53.7 |
| Placebo | 34.0 |
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
| Intervention | percentage of participants (Number) |
|---|---|
| Budesonide | 50.0 |
| Placebo | 28.6 |
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
| Intervention | percentage of participants (Number) |
|---|---|
| Budesonide | 46.3 |
| Placebo | 23.8 |
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
| Intervention | percentage of participants (Number) |
|---|---|
| Budesonide | 56.0 |
| Placebo | 36.7 |
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
| Intervention | percentage of participants (Number) |
|---|---|
| Budesonide | 49.3 |
| Placebo | 28.6 |
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
| Intervention | percentage of participants (Number) |
|---|---|
| Budesonide | 57.5 |
| Placebo | 38.8 |
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
| Intervention | percentage of participants (Number) |
|---|---|
| Budesonide | 72.4 |
| Placebo | 56.5 |
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
| Intervention | percentage of participants (Number) |
|---|---|
| Budesonide | 44.0 |
| Placebo | 22.4 |
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
| Intervention | unit on a scale (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Bowel frequency score: Baseline | Bowel frequency score: Change at Week 6 | Rectal Bleeding score:Baseline | Rectal Bleeding score: Change at Week 6 | PGA score:Baseline | PGA score: Change at Week 6 | Endoscopy score:Baseline | Endoscopy score: Change at Week 6 | Total score:Baseline | Total score: Change at Week 6 | |
| Budesonide | 1.7 | -0.8 | 2.1 | -1.3 | 2.0 | -0.9 | 2.1 | -0.9 | 7.9 | -3.8 |
| Placebo | 1.8 | -0.5 | 2.1 | -0.9 | 2.0 | -0.6 | 2.1 | -0.5 | 8.0 | -2.5 |
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
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| Responder at 1 assessment | Responder at 2 assessment | Responder at 3 assessment | Responder at 4 assessment | |
| Budesonide | 8.2 | 16.4 | 21.6 | 13.4 |
| Placebo | 18.4 | 17.0 | 7.5 | 2.0 |
6 reviews available for mesalamine and Proctocolitis
| Article | Year |
|---|---|
Should maintenance therapy be performed in ulcerative proctitis? How long should it be continued?
Topics: Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Enema; Humans; Mesalamine; Proctocolit | 2012 |
Diagnosis and treatment of ulcerative proctitis.
Topics: Acute Disease; Diagnosis, Differential; Diarrhea; Hemorrhage; Humans; Mesalamine; Proctocolitis; Rec | 2004 |
[Treatment of chronic inflammatory bowel diseases].
Topics: Adolescent; Adrenal Cortex Hormones; Adult; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Ste | 2007 |
[Changing treatment of inflammatory bowel diseases].
Topics: Adrenal Cortex Hormones; Aminosalicylic Acids; Anti-Inflammatory Agents; Anti-Inflammatory Agents, N | 1994 |
Hypersensitivity to 5-ASA suppositories.
Topics: Administration, Rectal; Aminosalicylic Acids; Anti-Inflammatory Agents, Non-Steroidal; Drug Hypersen | 1997 |
Medical management of ulcerative proctitis, proctosigmoiditis, and left-sided colitis.
Topics: Administration, Oral; Administration, Rectal; Administration, Topical; Adult; Anti-Inflammatory Agen | 2001 |
12 trials available for mesalamine and Proctocolitis
| Article | Year |
|---|---|
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.
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.
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.
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.
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.
Topics: Administration, Rectal; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-St | 2008 |
Prevention of acute radiation-induced proctosigmoiditis by balsalazide: a randomized, double-blind, placebo controlled trial in prostate cancer patients.
Topics: Acute Disease; Aged; Aminosalicylic Acids; Anti-Ulcer Agents; Colon, Sigmoid; Double-Blind Method; H | 2005 |
Dose-ranging study of mesalamine (PENTASA) enemas in the treatment of acute ulcerative proctosigmoiditis: results of a multicentered placebo-controlled trial. The U.S. PENTASA Enema Study Group.
Topics: Acute Disease; Adult; Analysis of Variance; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcera | 1998 |
Comparison of mesalazine suppositories in proctitis and distal proctosigmoiditis.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Drug Administration Schedule; Female; Humans; Male; | 1997 |
Mesalazine foam (Salofalk foam) in the treatment of active distal ulcerative colitis. A comparative trial vs Salofalk enema. The SAF-3 study group.
Topics: Administration, Topical; Adult; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Cross- | 1999 |
Short-chain fatty acid enemas: a cost-effective alternative in the treatment of nonspecific proctosigmoiditis.
Topics: Adult; Aminosalicylic Acids; Cost-Benefit Analysis; Enema; Fatty Acids, Volatile; Female; Humans; Hy | 1992 |
[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].
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Aminosalicylic Acids; Enema; Female; Humans; Hydrocortis | 1992 |
Mesalazine (5-aminosalicylic acid) suppositories in the treatment of ulcerative proctitis or distal proctosigmoiditis. A randomized controlled trial.
Topics: Adult; Aminosalicylic Acids; Colitis; Double-Blind Method; Female; Humans; Male; Mesalamine; Multice | 1990 |
Mesalamine for ulcerative colitis.
Topics: Aminosalicylic Acids; Clinical Trials as Topic; Colitis, Ulcerative; Dose-Response Relationship, Dru | 1988 |
Proctocolitis unresponsive to conventional therapy. Response to 5-aminosalicylic acid enemas.
Topics: Adult; Aminosalicylic Acids; Clinical Trials as Topic; Colitis; Enema; Female; Follow-Up Studies; Hu | 1987 |
5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis.
Topics: Adult; Aminosalicylic Acids; Colitis; Colitis, Ulcerative; Enema; Female; Humans; Male; Mesalamine; | 1987 |
18 other studies available for mesalamine and Proctocolitis
| Article | Year |
|---|---|
Real-world evidence of quality of life improvement in patients with distal ulcerative colitis treated by mesalazine: the Quartz study.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Humans; Inflammatory Bowel Diseases; M | 2022 |
[Tuberculous liver abscess, anti-TNF alpha, and immune reconstitution inflammatory syndrome].
Topics: Adalimumab; Adult; Antirheumatic Agents; Antitubercular Agents; Drug Substitution; Drug Therapy, Com | 2020 |
Efficacy of topical 5-aminosalicylate monotherapy in patients with ulcerative proctitis with skip inflammation.
Topics: Administration, Ophthalmic; Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Ant | 2018 |
Acetarsol in the management of mesalazine-refractory ulcerative proctitis: a tertiary-level care experience.
Topics: Administration, Rectal; Adult; Anti-Inflammatory Agents; Arsenicals; Drug Resistance; Drug Substitut | 2019 |
[Organizing pneumonia during treatment with mesalazine].
Topics: Aged; Anti-Inflammatory Agents; Humans; Male; Mesalamine; Pneumonia; Proctocolitis; Pulmonary Eosino | 2014 |
[Mesalazine-induced acute hepatitis].
Topics: Administration, Oral; Alanine Transaminase; Anti-Inflammatory Agents, Non-Steroidal; Chemical and Dr | 2015 |
Intractable diarrhoea despite immune reconstitution in an HIV positive man.
Topics: Adult; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; CD4 Lymphocyte Count; Cytomeg | 2015 |
Oral 5-Aminosalicylate, Mesalamine Suppository, and Mesalamine Enema as Initial Therapy for Ulcerative Proctitis in Clinical Practice with Quality of Care Implications.
Topics: Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Ster | 2016 |
[Treating distal ulcerative colitis intrarectally. Foam instead of enema, low volume rather than high volume].
Topics: Administration, Rectal; Budesonide; Colitis, Ulcerative; Enema; Humans; Hydrocortisone; Mesalamine; | 2008 |
Mesalazine-induced interstitial nephritis.
Topics: Adolescent; Anti-Inflammatory Agents, Non-Steroidal; Humans; Male; Mesalamine; Nephritis, Interstiti | 2009 |
Brooke-Spiegler syndrome associated with ulcerative rectosigmoiditis.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Female; Humans; Mesalamine; Neoplastic Syndromes, He | 2013 |
Mesalazine-induced reversible infertility in a young male.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Humans; Infertility, Male; Male; Mesalamine; Proctoc | 2004 |
[Intestinal mucosa as the focal point. In distal ulcerative colitis relief with topical therapy].
Topics: Administration, Rectal; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Dosage Forms; | 2004 |
Sulphasalazine-induced infertility reversed on transfer to 5-aminosalicylic acid.
Topics: Adult; Aminosalicylic Acids; Delayed-Action Preparations; Humans; Infertility, Male; Male; Mesalamin | 1984 |
[Activity of the antioxidant system in patients with idiopathic proctocolitis and the effect of 5-aminosalicylic acid (Salofalk)].
Topics: Adult; Aminosalicylic Acids; Antioxidants; Catalase; Female; Glutathione; Glutathione Peroxidase; Hu | 1994 |
Effect of MEN 11467, a new tachykinin NK1 receptor antagonist, in acute rectocolitis induced by acetic acid in guinea-pigs.
Topics: Acetic Acid; Acute Disease; Administration, Rectal; Animals; Anti-Inflammatory Agents, Non-Steroidal | 1999 |
Drug-induced fibrosing colonopathy in inflammatory bowel disease after 5-ASA?
Topics: Anti-Inflammatory Agents, Non-Steroidal; Colonic Diseases; Fibrosis; Humans; Mesalamine; Proctocolit | 1999 |
Enemas for IBD maintenance therapy.
Topics: Aminosalicylic Acids; Colitis; Enema; Humans; Mesalamine; Proctocolitis | 1989 |