mesalamine has been researched along with Gastrointestinal Hemorrhage in 45 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.
Gastrointestinal Hemorrhage: Bleeding in any segment of the GASTROINTESTINAL TRACT from ESOPHAGUS to RECTUM.
| Excerpt | Relevance | Reference |
|---|---|---|
| "The aim of the present study was to determine whether the split products of sulfasalazine, sulfapyridine, and 5-aminosalicylic acid can ameliorate ischemia/reperfusion-induced injury to the gastric mucosa." | 3.67 | 5-Aminosalicylic acid protects against ischemia/reperfusion-induced gastric bleeding in the rat. ( Grisham, MB; Kvietys, PR; Manci, EA; Smith, SM, 1988) |
| " The most common adverse events reported were worsening of UC and headache; both were reported more often in the placebo group." | 2.74 | Safety and efficacy of a new 3.3 g b.i.d. tablet formulation in patients with mild-to-moderately-active ulcerative colitis: a multicenter, randomized, double-blind, placebo-controlled study. ( Forbes, WP; Gordon, GL; Huang, S; Lamet, M; Mareya, S; Pruitt, R; Scherl, EJ; Shaw, A, 2009) |
| "Disease activity was assessed using the ulcerative colitis disease activity index, with clinical and endoscopic signs at four and eight weeks." | 2.71 | Combined oral and enema treatment with Pentasa (mesalazine) is superior to oral therapy alone in patients with extensive mild/moderate active ulcerative colitis: a randomised, double blind, placebo controlled study. ( Befrits, R; Dignass, A; Foldager, M; Gassul, M; Lindgren, S; Marteau, P; Midhagen, G; Probert, CS; Rademaker, J; Tan, TG, 2005) |
| " Time to symptom resolution was defined as the period between first drug dosage date and first 3 consecutive days of induction therapy when the patient achieved a score of 0 [normal] on a modified UC Disease Activity Index for stool frequency and/or rectal bleeding." | 2.66 | Time to Symptom Resolution in Ulcerative Colitis With Multimatrix Mesalazine Treatment: A Pooled Analysis. ( Barrett, K; Hanauer, SB; Sandborn, WJ; Schreiber, S, 2020) |
| "Mesalamine is a first-line drug in the treatment of inflammatory bowel diseases, while its intolerance occasionally occurs in clinical practice." | 2.61 | The culprit of mesalamine intolerance: case series and literature review. ( Fu, Y; Hong, F; Quan, R; Xie, C; Yan, W; Zou, K, 2019) |
| " The total numbers of adverse events associated with BDP and 5-ASA treatments for UC were similar (OR = 1." | 2.53 | Efficacy and Safety of Beclomethasone Dipropionate versus 5-Aminosalicylic Acid in the Treatment of Ulcerative Colitis: A Systematic Review and Meta-Analysis. ( Li, N; Ma, T; Ren, Y; Wang, C; Wang, J; You, S; Zhao, X, 2016) |
| "Segmental colitis associated with colonic diverticulosis is a new and emerging entity." | 2.48 | Segmental colitis associated with diverticulosis: systematic evaluation of 486 cases with meta-analysis. ( Hoda, KK; Mann, NS, 2012) |
| "The diagnostic work-up of ulcerative colitis at presentation is based on the collection of clinical, microbiological, radiological, endoscopic and histologic data." | 2.42 | Review article: diagnosis, monitoring and treatment of distal colitis. ( De Franchis, R; Devani, M; Rondonotti, E; Saibeni, S; Vecchi, M, 2003) |
| "Drugs for the treatment of ulcerative colitis are sulphapyridine, 5-aminosalicylic acid, prednisolone, betamethasone and immunosuppressive drugs." | 2.40 | [Ulcerative colitis and intestinal bleeding]. ( Asakura, H, 1998) |
| "A pregnant woman with severe ulcerative colitis was treated with a dose of mesalazine 4,000 mg/day from early gestation to delivery." | 1.62 | Maternal mesalazine-induced neonatal gastrointestinal bleeding. ( Kuboi, T; Nii, K; Okada, H; Okazaki, K, 2021) |
| "Eosinophilic colitis is a rare mostly self-limiting disease affecting middle-aged adults." | 1.40 | Eosinophilic colitis is a sporadic self-limited disease of middle-aged people: a population-based study. ( Alfadda, AA; Shaffer, EA; Storr, MA; Urbanski, SJ, 2014) |
| "This syndrome is diagnosed based on clinical symptoms and endoscopic and histological findings, but SRUS often goes unrecognized or is easily confused with other diseases such as inflammatory bowel disease, amoebiasis, malignancy, and other causes of rectal bleeding such as a juvenile polyps." | 1.39 | Solitary rectal ulcer syndrome in children: a report of six cases. ( Eken, KG; Kalyoncu, D; Urgancı, N, 2013) |
| "She had past history of ulcerative colitis with the continued medication of mesalazine without success." | 1.36 | Combinational effect of low-dose oral corticosteroid and mizoribine for ulcerative colitis in a patient with systemic sclerosis. ( Ohtsuka, T, 2010) |
| "This report presents two cases of ulcerative colitis in which lymph folliculitis and lymphoid hyperplasia were observed." | 1.31 | Lymph folliculitis in ulcerative colitis. ( Abe, T; Chiba, M; Fujiwara, K; Iizuka, M; Watanabe, S; Yamano, H, 2001) |
| "We report a case of Crohn's disease in a 32-year old Saudi male." | 1.31 | Crohn's disease presenting as life-threatening ileal bleeding. ( Ahmad, TM; Al-Been, H; De Keersmaecker, J; Tysk, C, 2000) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 2 (4.44) | 18.7374 |
| 1990's | 6 (13.33) | 18.2507 |
| 2000's | 13 (28.89) | 29.6817 |
| 2010's | 21 (46.67) | 24.3611 |
| 2020's | 3 (6.67) | 2.80 |
| Authors | Studies |
|---|---|
| Ma, C | 1 |
| Sandborn, WJ | 5 |
| D'Haens, GR | 1 |
| Zou, G | 1 |
| Stitt, LW | 1 |
| Singh, S | 1 |
| Ananthakrishnan, AN | 1 |
| Dulai, PS | 1 |
| Khanna, R | 2 |
| Jairath, V | 2 |
| Feagan, BG | 3 |
| Schreiber, S | 1 |
| Hanauer, SB | 2 |
| Barrett, K | 1 |
| Nii, K | 1 |
| Okazaki, K | 1 |
| Okada, H | 1 |
| Kuboi, T | 1 |
| Sato, S | 1 |
| Yashiro, M | 1 |
| Matsuoka, N | 1 |
| Kawana, S | 1 |
| Asano, T | 1 |
| Kobayashi, H | 1 |
| Tasaki, K | 1 |
| Watanabe, H | 1 |
| Hashimoto, Y | 1 |
| Migita, K | 1 |
| Yamauchi, R | 1 |
| Araki, T | 1 |
| Mitsuyama, K | 1 |
| Tokito, T | 1 |
| Ishii, H | 1 |
| Yoshioka, S | 1 |
| Kuwaki, K | 1 |
| Mori, A | 1 |
| Yoshimura, T | 1 |
| Tsuruta, O | 1 |
| Torimura, T | 1 |
| Stokkeland, K | 1 |
| Höijer, J | 1 |
| Bottai, M | 1 |
| Söderberg-Löfdal, K | 1 |
| Bergquist, A | 1 |
| Xie, C | 1 |
| Quan, R | 1 |
| Hong, F | 1 |
| Zou, K | 1 |
| Yan, W | 1 |
| Fu, Y | 1 |
| Mann, NS | 1 |
| Hoda, KK | 1 |
| Sedano Casas, A | 1 |
| Gato Díez, A | 1 |
| Mora Escudero, I | 1 |
| García Ángel, RD | 1 |
| Probert, CS | 2 |
| Dignass, AU | 1 |
| Lindgren, S | 2 |
| Oudkerk Pool, M | 1 |
| Marteau, P | 3 |
| Alfadda, AA | 1 |
| Shaffer, EA | 1 |
| Urbanski, SJ | 1 |
| Storr, MA | 1 |
| Urgancı, N | 1 |
| Kalyoncu, D | 1 |
| Eken, KG | 1 |
| Ninan, S | 1 |
| Hamlin, J | 1 |
| Hernández Martínez, A | 1 |
| Lázaro Sáez, M | 1 |
| Bendezú García, RA | 1 |
| Patrón Román, GO | 1 |
| Mellinger, JL | 1 |
| Pletneva, M | 1 |
| Fontana, RJ | 1 |
| Zou, GY | 1 |
| Stitt, L | 1 |
| Mosli, M | 1 |
| Vandervoort, MK | 1 |
| D'Haens, G | 1 |
| Levesque, BG | 1 |
| Zhao, X | 1 |
| Li, N | 1 |
| Ren, Y | 1 |
| Ma, T | 1 |
| Wang, C | 1 |
| Wang, J | 1 |
| You, S | 1 |
| Monteserín, L | 1 |
| Jiménez, M | 1 |
| Molina, G | 1 |
| Reyes, N | 1 |
| Hernando, M | 1 |
| Sierra, M | 1 |
| Vaquero, L | 1 |
| Leifeld, L | 1 |
| Kruis, W | 1 |
| Freeman, HJ | 1 |
| Law, JK | 1 |
| Salh, B | 1 |
| Yoshida, EM | 1 |
| Scherl, EJ | 1 |
| Pruitt, R | 1 |
| Gordon, GL | 1 |
| Lamet, M | 1 |
| Shaw, A | 1 |
| Huang, S | 1 |
| Mareya, S | 1 |
| Forbes, WP | 1 |
| Regula, J | 1 |
| Belousova, E | 1 |
| Jojic, N | 1 |
| Lukas, M | 1 |
| Yacyshyn, B | 1 |
| Krzeski, P | 1 |
| Yeh, CH | 1 |
| Messer, CA | 1 |
| Ohtsuka, T | 1 |
| Karabiber, H | 1 |
| Oguzkurt, DG | 1 |
| Dogan, DG | 1 |
| Aktas, M | 1 |
| Selimoglu, MA | 1 |
| Hanauer, S | 1 |
| Lichtenstein, GR | 1 |
| Safdi, M | 1 |
| Edeline, M | 1 |
| Scott Harris, M | 1 |
| Funato, M | 1 |
| Fukao, T | 1 |
| Sasai, H | 1 |
| Hori, T | 1 |
| Terazawa, D | 1 |
| Kubota, K | 1 |
| Ozeki, M | 1 |
| Orii, K | 1 |
| Kaneko, H | 1 |
| Kondo, N | 1 |
| Denız, K | 1 |
| Coban, G | 1 |
| Ozbakir, O | 1 |
| Denız, E | 1 |
| Kelly, S | 1 |
| Felley, C | 1 |
| Michetti, P | 1 |
| Castro Fernández, M | 1 |
| García Díaz, E | 1 |
| Romero, M | 1 |
| Galán Jurado, V | 1 |
| Rodríguez Alonso, C | 1 |
| Jani, AL | 1 |
| Hamilos, D | 1 |
| Vecchi, M | 1 |
| Saibeni, S | 1 |
| Devani, M | 1 |
| Rondonotti, E | 1 |
| De Franchis, R | 1 |
| Gassul, M | 1 |
| Tan, TG | 1 |
| Dignass, A | 1 |
| Befrits, R | 1 |
| Midhagen, G | 1 |
| Rademaker, J | 1 |
| Foldager, M | 1 |
| Ono, M | 1 |
| Murakami, K | 1 |
| Oda, M | 1 |
| Miyajima, H | 1 |
| Watanabe, K | 1 |
| Sato, R | 1 |
| Nasu, M | 1 |
| Kashima, K | 1 |
| Halphen, M | 1 |
| Gendre, JP | 1 |
| Declerck, D | 1 |
| Wallaert, B | 1 |
| Demarcq-Delerue, G | 1 |
| Tonnel, AB | 1 |
| Teshima, T | 1 |
| Hanks, GE | 1 |
| Hanlon, AL | 1 |
| Peter, RS | 1 |
| Schultheiss, TE | 1 |
| Asakura, H | 1 |
| Chiba, M | 1 |
| Yamano, H | 1 |
| Fujiwara, K | 1 |
| Abe, T | 1 |
| Iizuka, M | 1 |
| Watanabe, S | 1 |
| Tysk, C | 1 |
| De Keersmaecker, J | 1 |
| Al-Been, H | 1 |
| Ahmad, TM | 1 |
| Butt, JH | 1 |
| Kvietys, PR | 1 |
| Smith, SM | 1 |
| Grisham, MB | 1 |
| Manci, EA | 1 |
| Guarino, J | 1 |
| Chatzinoff, M | 1 |
| Berk, T | 1 |
| Friedman, LS | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Randomised, Active-Controlled, Double-Blind and Open Label Extensions Study to Evaluate the Efficacy, Long-Term Safety and Tolerability of TP05 3.2g/Day for the Treatment of Active Ulcerative Colitis[NCT01903252] | Phase 3 | 817 participants (Actual) | Interventional | 2013-07-31 | Completed | ||
| Investigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative Colitis[NCT04006080] | Phase 4 | 30 participants (Anticipated) | Interventional | 2019-07-01 | Recruiting | ||
| PhaRmacOkinetics and PHarmacodynamic BiomarkErs of Janus Kinase Inhibitor Therapy in PatIents With Ulcerative Colitis (PROPHETIC)[NCT04576000] | 3 participants (Actual) | Observational | 2020-08-25 | Terminated (stopped due to Not able to meet recruitment targets) | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Between-Group Difference of Endoscopic Score, Change from Baseline. The changes from baseline to week 8 values in sigmoidoscopic (mucosal) appearance scores will be compared between the two treatment groups. A value of 0 in the endoscopic score means normal or inactive disease and a value of 3 means severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between baseline to week 8 indicates treatment success. (NCT01903252)
Timeframe: Baseline and Week 8
| Intervention | units on a scale (Mean) |
|---|---|
| TP05 (Mesalazine) | 0.5 |
| Asacol (Mesalazine) | 0.6 |
"Between-Group Difference of Mayo Score, Change from Baseline The changes from baseline to week 8 values in Mayo scores are compared between the two treatment groups.~The Mayo scoring system is a well-established tool for assessing UC disease activity. The Mayo score is the sum of 4 component sub-scores, each scored on a scale ranging from 0 representing no pathology to 3 for severe disease. The 4 component sub-scores consist of, 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician's global assessment. A Mayo score of 0 indicates no pathology and a score of 12, severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A larger change in Mayo score from baseline when patients experienced acute disease, indicates improvement and treatment success." (NCT01903252)
Timeframe: Baseline and Week 8
| Intervention | units on a scale (Mean) |
|---|---|
| TP05 (Mesalazine) | 3.1 |
| Asacol (Mesalazine) | 3.2 |
Between-Group Difference of Partial Mayo Score, Change from Baseline to Week 8 The Partial Mayo Score is the sum of the component sub-scores, 1) stool frequency, 2) rectal bleeding and 3) physician's global assessment. A partial Mayo Score of 0 indicates no disease and a maximum score of 9 indicates severe symptoms. Change from Baseline is calculated Baseline-score minus week 8-score. A larger change in Partial Mayo Score from Baseline where patients experienced acute disease, indicates improvement and treatment success. (NCT01903252)
Timeframe: Baseline and Week 8
| Intervention | units on a scale (Mean) |
|---|---|
| TP05 (Mesalazine) | 2.5 |
| Asacol (Mesalazine) | 2.5 |
"Between-Group Difference of Physician Global Assessment Score, Change from Baseline.~The changes from baseline to week 8 values in the Physician Global Assessment score will be compared between the two treatment groups. A value of 0 means no pathology and a value of 3 means severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between baseline to week 8 indicates treatment success." (NCT01903252)
Timeframe: Baseline and Week 8
| Intervention | units on a scale (Mean) |
|---|---|
| TP05 (Mesalazine) | 0.6 |
| Asacol (Mesalazine) | 0.7 |
Between-Group Difference of Rectal Bleeding Score, Change from Baseline The changes from baseline to week 8 values in rectal bleeding scores will be compared between the two treatment groups. A value of 0 indicates no rectal bleeding, a value of 3 indicates only blood is passing. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference at week 8 compared to baseline is indicative of treatment success. (NCT01903252)
Timeframe: Baseline and Week 8
| Intervention | units on a scale (Mean) |
|---|---|
| TP05 (Mesalazine) | 0.9 |
| Asacol (Mesalazine) | 1.0 |
Between-Group Difference of Stool Frequency Score, Change from Baseline The changes from baseline to week 8 values in stool frequency will be compared between the two treatment groups. Values for stool frequency range between 0 and 3. A value of 0 indicates normal stool frequency, a value of 3 indicates 5 or more stools than normal. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between week 8 values and baselines indicates treatment success. (NCT01903252)
Timeframe: Baseline and Week 8
| Intervention | units on a scale (Mean) |
|---|---|
| TP05 (Mesalazine) | 0.9 |
| Asacol (Mesalazine) | 0.9 |
Mayo Score of <= 2 points with no individual sub-score > 1 (NCT01903252)
Timeframe: Week 8
| Intervention | Participants (Count of Participants) |
|---|---|
| TP05 (Mesalazine) | 87 |
| Asacol (Mesalazine, Tillotts Pharma AG) | 95 |
Clinical and Endoscopic Response was defined as a decrease in the Mayo score of ≥3 points from baseline and a reduction of ≥ 30% from baseline with either an accompanying decrease in the rectal bleeding sub-score of at least 1 point or an absolute rectal bleeding sub-score of 0 or 1 at the Week 8 visit. If a subject withdrew from the study prior to Week 8 or their response status was not evaluable due to incomplete and/or invalid data, the subject was considered a non-responder. (NCT01903252)
Timeframe: Week 8
| Intervention | Participants (Count of Participants) |
|---|---|
| TP05 (Mesalazine) | 221 |
| Asacol (Mesalazine) | 236 |
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS) (NCT01903252)
Timeframe: Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| TP05 (Mesalazine) | 93 |
| Asacol (Mesalazine, Tillotts Pharma AG) | 113 |
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS) (NCT01903252)
Timeframe: Week 8
| Intervention | Participants (Count of Participants) |
|---|---|
| TP05 (Mesalazine) | 92 |
| Asacol (Mesalazine, Tillotts Pharma AG) | 110 |
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS) (NCT01903252)
Timeframe: Week 8 and week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| TP05 (Mesalazine) | 66 |
| Asacol (Mesalazine, Tillotts Pharma AG) | 80 |
A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0. (NCT01903252)
Timeframe: Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| TP05 (Mesalazine) | 223 |
| Asacol (Mesalazine, Tillotts Pharma AG) | 233 |
A decrease in the Partial Mayo Score of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0. (NCT01903252)
Timeframe: Week 8 and Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| TP05 (Mesalazine) | 216 |
| Asacol (Mesalazine, Tillotts Pharma AG) | 230 |
Endoscopic remission was defined as a Mayo endoscopy subscore of 0 (NCT01903252)
Timeframe: Week 8
| Intervention | Participants (Count of Participants) |
|---|---|
| TP05 (Mesalazine) | 36 |
| Asacol (Mesalazine, Tillotts Pharma AG) | 44 |
Endoscopic response was define as a reduction in the Mayo endoscopic sub score of at least one. (NCT01903252)
Timeframe: Week 8
| Intervention | Participants (Count of Participants) |
|---|---|
| TP05 (Mesalazine) | 185 |
| Asacol (Mesalazine, Tillotts Pharma AG) | 196 |
Rectal bleeding sub-score of 0 was defined as a sub score on the rectal bleeding component of the Mayo score (NCT01903252)
Timeframe: Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| TP05 (Mesalazine) | 193 |
| Asacol (Mesalazine, Tillotts Pharma AG) | 205 |
Rectal bleeding sub-score of 0 was defined as a sub score on the rectal bleeding component of the Mayo score (NCT01903252)
Timeframe: Week 8
| Intervention | Participants (Count of Participants) |
|---|---|
| TP05 (Mesalazine) | 212 |
| Asacol (Mesalazine, Tillotts Pharma AG) | 226 |
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS) (NCT01903252)
Timeframe: Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| Extended Induction | 53 |
A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0. (NCT01903252)
Timeframe: Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| Extended Induction | 183 |
Percentage of patients achieving the endpoint rectal bleeding sub-score of 0 (NCT01903252)
Timeframe: Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| Extended Induction | 146 |
Percentage of patients achieving the endpoint stool frequency sub-score of 0 (NCT01903252)
Timeframe: Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| Extended Induction | 64 |
Percentage of Patients Experiencing Complications related to UC (NCT01903252)
Timeframe: Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| Extended Induction | 0.0 |
Percentage of patients achieving an Urgency Score of 0. A score of 0 indicates no urgency reported in any of the three days prior to the visit at week 16. A score of 1 indicates urgency reported in any of the three days prior to the visits. (NCT01903252)
Timeframe: Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| Extended Induction | 109 |
Mayo Score of <= 2 points with no individual sub-score > 1 (NCT01903252)
Timeframe: Week 38
| Intervention | percentage of participants (Number) |
|---|---|
| 1.6g/Day Maintenance Open-Label | 65.8 |
| 3.2/Day Maintenance Open-Label | 39.4 |
| 4.8g/Day Maintenance Open-Label | 29.6 |
Both has to be achieved, Clinical and Endoscopic Response which is defined by a decrease from baseline in the Mayo score of ≥ 3 points and > 30% of the baseline score, with an accompanying decrease in the rectal bleeding sub-score of ≥ 1 point or an absolute rectal bleeding sub-score of 0 or 1. (NCT01903252)
Timeframe: Week 38
| Intervention | percentage of participants (Number) |
|---|---|
| 1.6g/Day Maintenance Open-Label | 89.6 |
| 3.2/Day Maintenance Open-Label | 78.1 |
| 4.8g/Day Maintenance Open-Label | 69.3 |
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS) (NCT01903252)
Timeframe: Week 38
| Intervention | percentage of participant (Number) |
|---|---|
| 1.6g/Day Maintenance Open-Label | 70.3 |
| 3.2/Day Maintenance Open-Label | 33.9 |
| 4.8g/Day Maintenance Open-Label | 30.7 |
A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0. (NCT01903252)
Timeframe: Week 38
| Intervention | percentage of participants (Number) |
|---|---|
| 1.6g/Day Maintenance Open-Label | 94.1 |
| 3.2/Day Maintenance Open-Label | 83.9 |
| 4.8g/Day Maintenance Open-Label | 78.4 |
Percentage of each dose group achieving an endoscopy sub score of 0 (NCT01903252)
Timeframe: Week 38
| Intervention | percentage of participants (Number) |
|---|---|
| 1.6g/Day Maintenance Open-Label | 37.6 |
| 3.2/Day Maintenance Open-Label | 32.4 |
| 4.8g/Day Maintenance Open-Label | 13.6 |
Endoscopic response was define as a reduction in the Mayo endoscopic sub score of at least one. (NCT01903252)
Timeframe: Week 38
| Intervention | percentage of participants (Number) |
|---|---|
| 1.6g/Day Maintenance Open-Label | 73.8 |
| 3.2/Day Maintenance Open-Label | 58.8 |
| 4.8g/Day Maintenance Open-Label | 53.3 |
No urgency is a score of 0 and indicates that patients did not report urgency during any of the three days prior to the visit at week 38. A score of 1 indicates that urgency was reported during any of these three days. (NCT01903252)
Timeframe: Week 38
| Intervention | Participants (Count of Participants) |
|---|---|
| 1.6g/Day Maintenance Open-Label | 161 |
| 3.2/Day Maintenance Open-Label | 173 |
| 4.8g/Day Maintenance Open-Label | 109 |
Percentage of each dose group achieving the endpoint rectal bleeding subscore 0 (NCT01903252)
Timeframe: Week 38
| Intervention | percentage of participants (Number) |
|---|---|
| 1.6g/Day Maintenance Open-Label | 88.1 |
| 3.2/Day Maintenance Open-Label | 76.3 |
| 4.8g/Day Maintenance Open-Label | 74.9 |
Patients achieving a Stool Frequency sub-score of 0 (NCT01903252)
Timeframe: Week 38
| Intervention | Participants (Count of Participants) |
|---|---|
| 1.6g/Day Maintenance Open-Label | 148 |
| 3.2/Day Maintenance Open-Label | 101 |
| 4.8g/Day Maintenance Open-Label | 66 |
Percentage of Patients with Complications related to UC (NCT01903252)
Timeframe: Week 38
| Intervention | Participants (Count of Participants) |
|---|---|
| 1.6g/Day Maintenance Open-Label | 3 |
| 3.2/Day Maintenance Open-Label | 2 |
| 4.8g/Day Maintenance Open-Label | 1 |
10 reviews available for mesalamine and Gastrointestinal Hemorrhage
| Article | Year |
|---|---|
Time to Symptom Resolution in Ulcerative Colitis With Multimatrix Mesalazine Treatment: A Pooled Analysis.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Colonoscopy; Dose-Response Rela | 2020 |
The characteristics of nivolumab-induced colitis: an evaluation of three cases and a literature review.
Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Antibodies, Monoclonal; Antineoplastic Agents; Coliti | 2018 |
The culprit of mesalamine intolerance: case series and literature review.
Topics: Abdominal Pain; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Diarrhea; Drug Eruptio | 2019 |
Segmental colitis associated with diverticulosis: systematic evaluation of 486 cases with meta-analysis.
Topics: Abdominal Pain; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Biopsy; Colitis; Colonosco | 2012 |
Efficacy and Safety of Beclomethasone Dipropionate versus 5-Aminosalicylic Acid in the Treatment of Ulcerative Colitis: A Systematic Review and Meta-Analysis.
Topics: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Beclomethasone; Colitis, Ulcerati | 2016 |
Review article: diagnosis, monitoring and treatment of distal colitis.
Topics: Acute Disease; Administration, Oral; Administration, Rectal; Anti-Inflammatory Agents, Non-Steroidal | 2003 |
[A case of simple ulcer with ulcerative colitis].
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Azathioprine; Behcet Syndrome; Cecal Diseases; Colit | 2005 |
[Current medical treatment of hemorrhagic rectocolitis].
Topics: Adrenal Cortex Hormones; Aminosalicylic Acids; Anti-Bacterial Agents; Azathioprine; Colitis, Ulcerat | 1994 |
[Ulcerative colitis and intestinal bleeding].
Topics: Anti-Infective Agents; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Colitis, U | 1998 |
Outpatient management of inflammatory bowel disease. Let's keep it as simple as possible.
Topics: Abdominal Pain; Adrenal Cortex Hormones; Ambulatory Care; Aminosalicylic Acids; Anus Diseases; Diarr | 1992 |
6 trials available for mesalamine and Gastrointestinal Hemorrhage
29 other studies available for mesalamine and Gastrointestinal Hemorrhage
| Article | Year |
|---|---|
Discordance Between Patient-Reported Outcomes and Mucosal Inflammation in Patients With Mild to Moderate Ulcerative Colitis.
Topics: Adult; Colitis, Ulcerative; Gastrointestinal Hemorrhage; Humans; Inflammation; Mesalamine; Patient R | 2020 |
Maternal mesalazine-induced neonatal gastrointestinal bleeding.
Topics: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Female; Gast | 2021 |
Behçet disease associated with gastrointestinal amyloidosis manifested as hematochezia: A case report.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Behcet Syndrome; Colchicine; Colon; Colonic Diseases; Gastr | 2018 |
Statin Use Is Associated With Improved Outcomes of Patients With Primary Sclerosing Cholangitis.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Azathioprine; Cholagogues and Choleretics; Cholangit | 2019 |
[Cholesterol emboli-induced ischemic colitis].
Topics: Aged; Anti-Inflammatory Agents; Colitis, Ischemic; Colitis, Ulcerative; Colonoscopy; Diagnostic Erro | 2013 |
Eosinophilic colitis is a sporadic self-limited disease of middle-aged people: a population-based study.
Topics: Abdominal Pain; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Cohort Studies; Colitis; Colon | 2014 |
Solitary rectal ulcer syndrome in children: a report of six cases.
Topics: Adolescent; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Child; Colonoscopy; Female; | 2013 |
The young patient with acute bloody diarrhoea.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Antibodies, Monoclonal; Azathioprine; C-Reactive Pro | 2014 |
[Chemical proctitis due to ergotamine: «not always an ulcerative colitis»].
Topics: Acetaminophen; Aged; Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Diagnosis, Differ | 2015 |
New Onset Bloody Diarrhea in a Liver Transplant Recipient. New Onset Bloody Diarrhea in a Liver Transplant Recipient.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Colitis, Ulcerative; Diarrhea; Gastrointestinal Hemorrhage; | 2015 |
Colonic pseudopolyposis in inflammatory bowel disease.
Topics: Adult; Anemia, Iron-Deficiency; Anti-Inflammatory Agents, Non-Steroidal; Biopsy; Colitis, Ulcerative | 2017 |
[Modern therapy of diverticular disease].
Topics: Abscess; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroi | 2008 |
Segmental colitis associated with diverticulosis syndrome.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Colitis; Diagnosis, Differential; Disease Progression; Dive | 2008 |
All that bleeds is not infliximab-refractory ulcerative colitis.
Topics: Adult; Anti-Inflammatory Agents; Antibodies, Monoclonal; Asian People; Colitis, Ulcerative; Drug Res | 2009 |
Combinational effect of low-dose oral corticosteroid and mizoribine for ulcerative colitis in a patient with systemic sclerosis.
Topics: Adrenal Cortex Hormones; Antibodies, Antinuclear; Colitis, Ulcerative; Drug Therapy, Combination; Es | 2010 |
An unusual cause of rectal bleeding: intestinal myiasis.
Topics: Albendazole; Anthelmintics; Antinematodal Agents; Cathartics; Child; Diagnosis, Differential; Female | 2010 |
Early symptomatic response and mucosal healing with mesalazine rectal suspension therapy in active distal ulcerative colitis--additional results from two controlled studies.
Topics: Administration, Oral; Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Infl | 2011 |
Successful treatment of pediatric immune thrombocytopenic purpura associated with ulcerative colitis.
Topics: Anemia; Child; Colitis, Ulcerative; Female; Gastrointestinal Hemorrhage; Humans; Mesalamine; Prednis | 2011 |
Pseudomembranous collagenous colitis.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Colitis, Collagenous; Colonoscopy; Diarrhea; Enterocolitis, | 2012 |
Ulcerative colitis.
Topics: Anecdotes as Topic; Anti-Inflammatory Agents, Non-Steroidal; Chronic Disease; Colitis, Ulcerative; D | 2012 |
[Ulcerative colitis].
Topics: Anti-Inflammatory Agents, Non-Steroidal; Biopsy; Colitis, Ulcerative; Colonoscopy; Diagnosis, Differ | 2002 |
[Treatment of steroid-refractory ulcerative colitis with infliximab].
Topics: Adult; Anti-Bacterial Agents; Antibodies, Monoclonal; Azathioprine; Blood Transfusion; Budesonide; C | 2003 |
Bloody diarrhea, fever, and pancytopenia in a patient with active ulcerative colitis.
Topics: Antibodies, Antineutrophil Cytoplasmic; Antibodies, Antinuclear; Autoantigens; Autoimmune Diseases; | 2003 |
[Iatrogenic diffuse interstitial pneumonia linked to 5-aminosalicylate].
Topics: Aminosalicylic Acids; Colitis; Drug Therapy, Combination; Female; Gastrointestinal Hemorrhage; Human | 1994 |
Rectal bleeding after conformal 3D treatment of prostate cancer: time to occurrence, response to treatment and duration of morbidity.
Topics: Aged; Aged, 80 and over; Aminosalicylic Acids; Anti-Inflammatory Agents, Non-Steroidal; Gastrointest | 1997 |
Lymph folliculitis in ulcerative colitis.
Topics: Adult; Biopsy, Needle; Colitis, Ulcerative; Colonoscopy; Follow-Up Studies; Gastrointestinal Hemorrh | 2001 |
Crohn's disease presenting as life-threatening ileal bleeding.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Biopsy; Colectomy; Colonic Diseases; Critical Illnes | 2000 |
5-Aminosalicylic acid protects against ischemia/reperfusion-induced gastric bleeding in the rat.
Topics: Aminosalicylic Acids; Animals; Dimethyl Sulfoxide; Gastrointestinal Hemorrhage; Hydroxides; Hydroxyl | 1988 |
5-Aminosalicylic acid enemas in refractory distal ulcerative colitis: long-term results.
Topics: Adolescent; Adult; Aged; Aminosalicylic Acids; Colitis, Ulcerative; Drug Administration Schedule; En | 1987 |