Page last updated: 2024-10-22

alosetron and Irritable Bowel Syndrome

alosetron has been researched along with Irritable Bowel Syndrome in 67 studies

alosetron : A pyrido[4,3-b]indole compound having a 5-methyl-1H-imidazol-4-ylmethyl group at the 2-position.

Irritable Bowel Syndrome: A disorder with chronic or recurrent colonic symptoms without a clearcut etiology. This condition is characterized by chronic or recurrent ABDOMINAL PAIN, bloating, MUCUS in FECES, and an erratic disturbance of DEFECATION.

Research Excerpts

ExcerptRelevanceReference
"Alosetron is indicated for women with chronic, severe diarrhea-predominant IBS (d-IBS) who have not responded adequately to conventional therapy."9.12A randomized, double-blind, placebo-controlled study to assess efficacy and safety of 0.5 mg and 1 mg alosetron in women with severe diarrhea-predominant IBS. ( Ameen, V; Carter, EG; Gordon, SH; Heath, AT; Krause, R; Perschy, T; West, M, 2007)
"Long-term use of alosetron is effective and well-tolerated in women with chronic, diarrhea-predominant IBS, including those with more frequent urgency."9.11Long-term safety and efficacy of alosetron in women with severe diarrhea-predominant irritable bowel syndrome. ( Ameen, VZ; Carter, EG; Chey, WD; Chey, WY; Dukes, GE; Heath, AT; Northcutt, A, 2004)
"Alosetron 1 mg twice daily provided adequate relief of IBS pain and discomfort, and improved stool consistency in men with diarrhea-predominant IBS."9.11A dose-ranging, phase II study of the efficacy and safety of alosetron in men with diarrhea-predominant IBS. ( Ameen, VZ; Carter, EG; Chang, L; Dukes, GE; Mayer, EA; McSorley, DJ, 2005)
"The aim of this study was to assess the effect of alosetron on bowel urgency and irritable bowel syndrome (IBS) global improvement in diarrhea-predominant IBS (D-IBS)."9.11Effect of alosetron on bowel urgency and global symptoms in women with severe, diarrhea-predominant irritable bowel syndrome: analysis of two controlled trials. ( Ameen, VZ; Carter, EG; Gordon, SL; Heath, AT; Lembo, AJ; Olden, KW, 2004)
" Direct comparison of primary endpoint results from the alosetron, rifaximin, and eluxadoline pivotal trials is not possible; however, general estimates of efficacy can be made, and these demonstrate similar and significantly greater responses to 'adequate relief' and a composite endpoint of abdominal pain/stool form for each agent compared to placebo."8.93Rifaximin and eluxadoline - newly approved treatments for diarrhea-predominant irritable bowel syndrome: what is their role in clinical practice alongside alosetron? ( Cash, BD; Earnest, DL; Lacy, BE; Rao, T, 2016)
" The goal of this review is to discern IBS treatment gaps and identify opportunities for improving its management in the primary care setting, as well as describe the most current clinical experience with alosetron, a targeted treatment for severe diarrhea-predominant IBS (IBS-D) in women."8.87Alosetron for severe diarrhea-predominant irritable bowel syndrome: improving patient outcomes. ( Bleser, S, 2011)
"Ischemic colitis and serious complications of constipation have been reported in association with the use of alosetron, which is approved for women with severe diarrhea-predominant IBS who have failed conventional therapies."8.83Incidence of ischemic colitis and serious complications of constipation among patients using alosetron: systematic review of clinical trials and post-marketing surveillance data. ( Chang, L; Chey, WD; Harris, L; Olden, K; Schoenfeld, P; Surawicz, C, 2006)
"Alosetron (Lotronex, GlaxoSmithKline) is a potent and selective 5-HT(3)-receptor antagonist approved by the FDA for the treatment of women with diarrhoea-predominant irritable bowel syndrome (IBS) in whom conventional therapy has failed."8.82Alosetron and irritable bowel syndrome. ( Bradesi, S; Mayer, EA, 2003)
"Alosetron is a potent, selective 5-HT(3) receptor antagonist prescribed for women with severe diarrhea-predominant irritable bowel syndrome (IBS-D) under a risk management plan (RMP)."7.76Ischemic colitis and complications of constipation associated with the use of alosetron under a risk management plan: clinical characteristics, outcomes, and incidences. ( Ameen, V; Chang, L; Tong, K, 2010)
"The aim of this study was to establish a pathophysiologic model of irritable bowel syndrome, and then to evaluate the pharmaceutical efficacy of ramosetron, a potent serotonin 3 (5-HT(3)) receptor antagonist, and other anti-irritable bowel syndrome agents in this model."7.74Effect of ramosetron on conditioned emotional stress-induced colonic dysfunction as a model of irritable bowel syndrome in rats. ( Akuzawa, S; Funatsu, T; Hirata, T; Keto, Y; Sasamata, M; Takeuchi, A, 2007)
"We examined the pharmacological profile of ramosetron, a 5-HT(3)-receptor antagonist for irritable bowel syndrome with diarrhea, comparing it with those of other 5-HT(3)-receptor antagonists, alosetron and cilansetron, and the anti-diarrheal agent loperamide."7.74Evaluation of the pharmacological profile of ramosetron, a novel therapeutic agent for irritable bowel syndrome. ( Akuzawa, S; Funatsu, T; Hirata, T; Keto, Y; Sasamata, M, 2007)
" The present study examines the binding profile of platelet SERT in healthy volunteers as well as in patients with diarrhea-predominant irritable bowel syndrome (D-IBS), both before and after treatment with the 5-HT(3) receptor antagonist alosetron."7.72Platelet serotonin transporter in patients with diarrhea-predominant irritable bowel syndrome both before and after treatment with alosetron. ( Baroni, S; Bellini, M; Betti, L; Blandizzi, C; Colucci, R; Costa, F; Del Tacca, M; Giannaccini, G; Marazziti, D; Marchi, S; Mumolo, MG; Rappelli, L; Stasi, C, 2003)
"Alosetron vs placebo treatments, in a randomized, double-blinded, crossover manner, were studied."6.71The effects of the 5-HT3 antagonist, alosetron, on brain serotonin synthesis in patients with irritable bowel syndrome. ( D'Souza, D; Diksic, M; Kersey, K; Kumakura, Y; Nakai, A, 2005)
"Irritable bowel syndrome is categorized into one of three main categories: IBS with diarrhea, IBS with constipation, and IBS with mixed bowel habits."6.53Emerging treatments in neurogastroenterology: eluxadoline - a new therapeutic option for diarrhea-predominant IBS. ( Lacy, BE, 2016)
"Alosetron was not associated with any deaths."6.44Efficacy and tolerability of alosetron for the treatment of irritable bowel syndrome in women and men: a meta-analysis of eight randomized, placebo-controlled, 12-week trials. ( Abdollahi, M; Nikfar, S; Rahimi, R, 2008)
"Alosetron is a potent and highly selective serotonin 5-HT(3 )receptor antagonist that in large randomised controlled clinical trials has been shown to be clinically efficient in female patients with diarrhoea-predominant IBS."6.42Reassessing the benefits and risks of alosetron: what is its place in the treatment of irritable bowel syndrome? ( Andresen, V; Hollerbach, S, 2004)
" Incidence of adverse events during alosetron use was not remarkable and was similar to that previously reported."5.51Alosetron versus traditional pharmacotherapy in clinical practice: effects on resource use, health-related quality of life, safety and symptom improvement in women with severe diarrhea-predominant irritable bowel syndrome. ( Chey, WD; Chuang, E; Earnest, DL; Olden, KW; Paul Nicandro, J; Shringarpure, R, 2019)
"Irritable bowel syndrome affects 5-10% of North Americans, with an estimated one-third having a diarrhea-predominant form."5.36Alosetron for severe diarrhea-predominant irritable bowel syndrome: safety and efficacy in perspective. ( Lewis, JH, 2010)
"Because the mechanism(s) of drug-induced ischemic colitis and possibly other forms of intestinal ischemia associated with alosetron have not been elucidated, there is need to further assess risk with regard to patient susceptibility and other factors."5.33Alosetron: ischemic colitis and serious complications of constipation. ( Avigan, M; Brinker, A; Gallo-Torres, H, 2006)
"Alosetron is indicated for women with chronic, severe diarrhea-predominant IBS (d-IBS) who have not responded adequately to conventional therapy."5.12A randomized, double-blind, placebo-controlled study to assess efficacy and safety of 0.5 mg and 1 mg alosetron in women with severe diarrhea-predominant IBS. ( Ameen, V; Carter, EG; Gordon, SH; Heath, AT; Krause, R; Perschy, T; West, M, 2007)
"The aim of this study was to assess the effect of alosetron on bowel urgency and irritable bowel syndrome (IBS) global improvement in diarrhea-predominant IBS (D-IBS)."5.11Effect of alosetron on bowel urgency and global symptoms in women with severe, diarrhea-predominant irritable bowel syndrome: analysis of two controlled trials. ( Ameen, VZ; Carter, EG; Gordon, SL; Heath, AT; Lembo, AJ; Olden, KW, 2004)
"Alosetron 1 mg twice daily provided adequate relief of IBS pain and discomfort, and improved stool consistency in men with diarrhea-predominant IBS."5.11A dose-ranging, phase II study of the efficacy and safety of alosetron in men with diarrhea-predominant IBS. ( Ameen, VZ; Carter, EG; Chang, L; Dukes, GE; Mayer, EA; McSorley, DJ, 2005)
"Long-term use of alosetron is effective and well-tolerated in women with chronic, diarrhea-predominant IBS, including those with more frequent urgency."5.11Long-term safety and efficacy of alosetron in women with severe diarrhea-predominant irritable bowel syndrome. ( Ameen, VZ; Carter, EG; Chey, WD; Chey, WY; Dukes, GE; Heath, AT; Northcutt, A, 2004)
" Direct comparison of primary endpoint results from the alosetron, rifaximin, and eluxadoline pivotal trials is not possible; however, general estimates of efficacy can be made, and these demonstrate similar and significantly greater responses to 'adequate relief' and a composite endpoint of abdominal pain/stool form for each agent compared to placebo."4.93Rifaximin and eluxadoline - newly approved treatments for diarrhea-predominant irritable bowel syndrome: what is their role in clinical practice alongside alosetron? ( Cash, BD; Earnest, DL; Lacy, BE; Rao, T, 2016)
"In irritable bowel syndrome with diarrhea, tricyclic antidepressants and alosetron are associated with a significant number needed to harm compared with rifaximin."4.88Evaluation of harm in the pharmacotherapy of irritable bowel syndrome. ( Chong, K; Kim, S; Lembo, A; Pimentel, M; Shah, E, 2012)
" The goal of this review is to discern IBS treatment gaps and identify opportunities for improving its management in the primary care setting, as well as describe the most current clinical experience with alosetron, a targeted treatment for severe diarrhea-predominant IBS (IBS-D) in women."4.87Alosetron for severe diarrhea-predominant irritable bowel syndrome: improving patient outcomes. ( Bleser, S, 2011)
"Ischemic colitis and serious complications of constipation have been reported in association with the use of alosetron, which is approved for women with severe diarrhea-predominant IBS who have failed conventional therapies."4.83Incidence of ischemic colitis and serious complications of constipation among patients using alosetron: systematic review of clinical trials and post-marketing surveillance data. ( Chang, L; Chey, WD; Harris, L; Olden, K; Schoenfeld, P; Surawicz, C, 2006)
"Alosetron (Lotronex, GlaxoSmithKline) is a potent and selective 5-HT(3)-receptor antagonist approved by the FDA for the treatment of women with diarrhoea-predominant irritable bowel syndrome (IBS) in whom conventional therapy has failed."4.82Alosetron and irritable bowel syndrome. ( Bradesi, S; Mayer, EA, 2003)
" Problems have arisen with alosetron being associated with ischaemic colitis and a high incidence of constipation."4.81Pharmacological treatment of irritable bowel syndrome--from concept to sales. ( Kamm, MA, 2002)
"More than one decade ago, rising cases of ischemic colitis (IC) prompted the Federal Drug Administration to revoke alosetron's approval as treatment of irritable bowel syndrome (IBS)."3.83Ischemic Colitis as a Complication of Medication Use: An Analysis of the Federal Adverse Event Reporting System. ( Bielefeldt, K, 2016)
"This article evaluates the characteristics and treatment patterns of female patients with severe diarrhea-predominant irritable bowel syndrome (IBS-D) who were treated with alosetron under a risk management program."3.78Evaluation of treatment continuation with alosetron by IBS-D severity criteria. ( Chuang, E; Nicandro, JP; Shin, P, 2012)
"Alosetron is a potent, selective 5-HT(3) receptor antagonist prescribed for women with severe diarrhea-predominant irritable bowel syndrome (IBS-D) under a risk management plan (RMP)."3.76Ischemic colitis and complications of constipation associated with the use of alosetron under a risk management plan: clinical characteristics, outcomes, and incidences. ( Ameen, V; Chang, L; Tong, K, 2010)
"Alosetron was reintroduced for treatment of irritable bowel syndrome with a risk management programme in November 2002."3.74The relationship between dosing of alosetron and discontinuation patterns reported by patients participating in a follow-up programme. ( Andrews, E; Cook, S; Hickman, P; Hollis, K; Miller, D; Tennis, P, 2007)
" Gastroenterologists and their patients have been affected adversely by removal from the marketplace of two licensed agents for irritable bowel syndrome (IBS): alosetron and tegaserod."3.74Balancing drug risk and benefit: toward refining the process of FDA decisions affecting patient care. ( Johnson, DA; Schiller, LR, 2008)
"We examined the pharmacological profile of ramosetron, a 5-HT(3)-receptor antagonist for irritable bowel syndrome with diarrhea, comparing it with those of other 5-HT(3)-receptor antagonists, alosetron and cilansetron, and the anti-diarrheal agent loperamide."3.74Evaluation of the pharmacological profile of ramosetron, a novel therapeutic agent for irritable bowel syndrome. ( Akuzawa, S; Funatsu, T; Hirata, T; Keto, Y; Sasamata, M, 2007)
"The aim of this study was to establish a pathophysiologic model of irritable bowel syndrome, and then to evaluate the pharmaceutical efficacy of ramosetron, a potent serotonin 3 (5-HT(3)) receptor antagonist, and other anti-irritable bowel syndrome agents in this model."3.74Effect of ramosetron on conditioned emotional stress-induced colonic dysfunction as a model of irritable bowel syndrome in rats. ( Akuzawa, S; Funatsu, T; Hirata, T; Keto, Y; Sasamata, M; Takeuchi, A, 2007)
"Alosetron hydrochloride (Lotronex, GlaxoSmithKline, Inc) is a safe and effective agent for selective patients with severe irritable bowel syndrome when prescribed as recommended."3.73Acute hepatitis associated with alosetron (Lotronex). ( Fontana, RJ; Tayeh, N; Turgeon, DK, 2005)
"In November 2002, alosetron HCl (Lotronex, GlaxoSmithKline Research Triangle Park, NC, USA) was re-introduced to the US marketplace for women with severe diarrhoea-predominant irritable bowel syndrome."3.73A patient follow-up survey programme for alosetron: assessing compliance to and effectiveness of the risk management programme. ( Andrews, E; Bennett, L; Cook, S; Hollis, K; Miller, D; Tennis, P, 2006)
" The present study examines the binding profile of platelet SERT in healthy volunteers as well as in patients with diarrhea-predominant irritable bowel syndrome (D-IBS), both before and after treatment with the 5-HT(3) receptor antagonist alosetron."3.72Platelet serotonin transporter in patients with diarrhea-predominant irritable bowel syndrome both before and after treatment with alosetron. ( Baroni, S; Bellini, M; Betti, L; Blandizzi, C; Colucci, R; Costa, F; Del Tacca, M; Giannaccini, G; Marazziti, D; Marchi, S; Mumolo, MG; Rappelli, L; Stasi, C, 2003)
"Alosetron vs placebo treatments, in a randomized, double-blinded, crossover manner, were studied."2.71The effects of the 5-HT3 antagonist, alosetron, on brain serotonin synthesis in patients with irritable bowel syndrome. ( D'Souza, D; Diksic, M; Kersey, K; Kumakura, Y; Nakai, A, 2005)
"Irritable bowel syndrome is categorized into one of three main categories: IBS with diarrhea, IBS with constipation, and IBS with mixed bowel habits."2.53Emerging treatments in neurogastroenterology: eluxadoline - a new therapeutic option for diarrhea-predominant IBS. ( Lacy, BE, 2016)
"Alosetron was not associated with any deaths."2.44Efficacy and tolerability of alosetron for the treatment of irritable bowel syndrome in women and men: a meta-analysis of eight randomized, placebo-controlled, 12-week trials. ( Abdollahi, M; Nikfar, S; Rahimi, R, 2008)
"The etiology of irritable bowel syndrome is considered to be multifactorial: experimental and clinical research on visceral hypersensitivity, motility and brain-gut axis involving its neurotransmitters and receptors created the foundation of novel therapeutic approaches."2.44[Novel therapeutic approaches in the treatment of irritable bowel syndrome]. ( Herszényi, L; Juhász, M; Miheller, P; Pregun, I; Tulassay, Z, 2007)
"Alosetron is a potent and highly selective serotonin 5-HT(3 )receptor antagonist that in large randomised controlled clinical trials has been shown to be clinically efficient in female patients with diarrhoea-predominant IBS."2.42Reassessing the benefits and risks of alosetron: what is its place in the treatment of irritable bowel syndrome? ( Andresen, V; Hollerbach, S, 2004)
"Alosetron was also efficacious in stress-induced defecation and visceral pain models at 1 and 10 mg/kg, respectively."1.56Pharmacological evaluation of a novel corticotropin-releasing factor 1 receptor antagonist T-3047928 in stress-induced animal models in a comparison with alosetron. ( Aso, K; Itomi, Y; Kawamura, T; Kojima, T; Matsumoto-Okano, S; Matsushita, K; Tanaka, T; Tsukimi, Y, 2020)
" Incidence of adverse events during alosetron use was not remarkable and was similar to that previously reported."1.51Alosetron versus traditional pharmacotherapy in clinical practice: effects on resource use, health-related quality of life, safety and symptom improvement in women with severe diarrhea-predominant irritable bowel syndrome. ( Chey, WD; Chuang, E; Earnest, DL; Olden, KW; Paul Nicandro, J; Shringarpure, R, 2019)
"Visceral pain was measured by visceromotor response to colorectal distension, and the effects of alosetron and duloxetine on visceral pain were investigated in SART rats."1.42Specific alteration of rhythm in temperature-stressed rats possess features of abdominal pain in IBS patients. ( Itomi, Y; Kawamura, T; Tsukimi, Y, 2015)
"Irritable bowel syndrome affects 5-10% of North Americans, with an estimated one-third having a diarrhea-predominant form."1.36Alosetron for severe diarrhea-predominant irritable bowel syndrome: safety and efficacy in perspective. ( Lewis, JH, 2010)
"WA stress led to visceral hyperalgesia 24 h later."1.34Dual role of 5-HT3 receptors in a rat model of delayed stress-induced visceral hyperalgesia. ( Bradesi, S; Hicks, GA; Lao, L; Lee, K; Mayer, EA; McLean, PG; Winchester, WJ, 2007)
"Because the mechanism(s) of drug-induced ischemic colitis and possibly other forms of intestinal ischemia associated with alosetron have not been elucidated, there is need to further assess risk with regard to patient susceptibility and other factors."1.33Alosetron: ischemic colitis and serious complications of constipation. ( Avigan, M; Brinker, A; Gallo-Torres, H, 2006)

Research

Studies (67)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's39 (58.21)29.6817
2010's25 (37.31)24.3611
2020's3 (4.48)2.80

Authors

AuthorsStudies
Asagarasu, A1
Matsui, T1
Hayashi, H1
Tamaoki, S1
Yamauchi, Y1
Minato, K1
Sato, M1
Manning, DD2
Cioffi, CL1
Usyatinsky, A1
Fitzpatrick, K1
Masih, L2
Guo, C2
Zhang, Z2
Choo, SH2
Sikkander, MI1
Ryan, KN2
Naginskaya, J2
Hassler, C1
Dobritsa, S1
Wierschke, JD2
Earley, WG2
Butler, AS1
Brady, CA2
Barnes, NM2
Cohen, ML1
Guzzo, PR2
Newman, AS1
Brenner, DM1
Sayuk, GS1
Itomi, Y2
Tanaka, T1
Matsushita, K1
Kawamura, T2
Kojima, T1
Aso, K1
Matsumoto-Okano, S1
Tsukimi, Y2
Chen, M1
Tang, TC1
Qin, D1
Yue, L1
Zheng, H1
Olden, KW2
Chey, WD5
Shringarpure, R2
Paul Nicandro, J1
Chuang, E3
Earnest, DL2
El-Ayache, N1
Galligan, JJ1
Nee, J1
Zakari, M1
Lembo, AJ2
Cash, BD2
Lacy, BE4
Rao, T1
Bielefeldt, K1
Dance, A1
Morgan, B1
Moreau, JC1
Talley, NJ1
Rahimi, R1
Nikfar, S1
Abdollahi, M1
Jarcho, JM1
Chang, L4
Berman, M1
Suyenobu, B1
Naliboff, BD1
Lieberman, MD1
Ameen, VZ4
Mandelkern, MA1
Mayer, EA5
Ford, AC1
Brandt, LJ1
Young, C1
Foxx-Orenstein, AE1
Moayyedi, P1
Lewis, JH2
Tong, K1
Ameen, V2
Bleser, S1
Saad, RJ1
Mönnikes, H1
Nicandro, JP2
Shin, P1
Shah, E1
Kim, S1
Chong, K1
Lembo, A3
Pimentel, M2
Kim, SE1
Kubomoto, S1
Chua, K1
Amichai, MM1
Cremonini, F1
Atkinson, V1
Ervin, CM1
Mangel, AW2
Scherl, E1
Frissora, CL1
Weber, HC1
Farraye, FA1
Bradesi, S2
Bellini, M1
Rappelli, L1
Blandizzi, C1
Costa, F1
Stasi, C1
Colucci, R1
Giannaccini, G1
Marazziti, D1
Betti, L1
Baroni, S1
Mumolo, MG1
Marchi, S1
Del Tacca, M1
Andresen, V2
Hollerbach, S1
Gordon, SL1
Heath, AT3
Carter, EG4
Chey, WY1
Dukes, GE2
Northcutt, A1
Johanson, JF1
Kennedy, T1
Rubin, G1
Jones, R1
McSorley, DJ1
Ehrenpreis, ED1
Nakai, A1
Diksic, M1
Kumakura, Y1
D'Souza, D1
Kersey, K1
Kawano, K1
Mori, T1
Fu, L1
Ito, T1
Niisato, T1
Yoshida, S1
Shiokawa, S1
Sato, Y1
Murakami, H1
Shishikura, T1
Turgeon, DK1
Tayeh, N1
Fontana, RJ1
Ismail, IM1
Andrew, PD1
Cholerton, J1
Roberts, AD1
Dear, GJ1
Taylor, S1
Koch, KM1
Saynor, DA1
Kamm, MA1
Harris, L1
Olden, K1
Surawicz, C1
Schoenfeld, P1
Gallo-Torres, H1
Brinker, A1
Avigan, M1
Komoto, S1
Miura, S1
Miller, D2
Bennett, L1
Hollis, K2
Tennis, P2
Cook, S2
Andrews, E2
Lao, L1
McLean, PG1
Winchester, WJ1
Lee, K1
Hicks, GA1
Podovei, M1
Kuo, B1
Hickman, P1
Mearin, F1
Krause, R1
Gordon, SH1
West, M1
Perschy, T1
Pregun, I1
Herszényi, L1
Juhász, M1
Miheller, P1
Tulassay, Z1
Hirata, T2
Keto, Y2
Funatsu, T2
Akuzawa, S2
Sasamata, M2
Takeuchi, A1
Montori, VM1
Keller, J1
West, CP1
Layer, P1
Camilleri, M1
Schiller, LR1
Johnson, DA1

Clinical Trials (3)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Effects of Rifaximin on Visceral Hypersensitivity in Irritable Bowel Syndrome[NCT03462966]Phase 24 participants (Actual)Interventional2018-07-01Terminated (stopped due to recruitment challenges)
Crossover Trial of Gluten and Gluten With Amylase-trypsin Inhibitors as Triggers of Gastrointestinal Symptoms in Patients With Irritable Bowel Syndrome[NCT03664531]34 participants (Anticipated)Interventional2019-01-01Recruiting
Confocal Endomicroscopy Utility for Diagnosing Mucosa Micro-inflammation in Patients With Irritable Bowel Syndrome[NCT02651532]74 participants (Actual)Observational2016-01-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Association of Urgency Symptom and Rectal Sensitivity Testing.

Association of urgency symptom and rectal sensitivity will be evaluated by the mean change in the balloon pressure (measured in mmHg) that leads to first urge sensation to defecate, evaluated based on the visual analogue scale defined in the primary outcome measure. (NCT03462966)
Timeframe: After completing 14-day course of rifaximin.

InterventionMillimetre of mercury (Mean)
Therapeutic106

Mean Change in the Balloon Volume (Measured in Cubic Centimeter) That Leads to First Urge to Defecate.

A 100-cubic centimeter visual analogue scale with verbal descriptors (0=no sensation, 20=first sensation, 40=first sense of urge, 60=normal urge to defecate, 80=severe urge to defecate, and 100=discomfort/pain) will be used to score evoked sensations. (NCT03462966)
Timeframe: After completing 14-day course of rifaximin.

Interventionvolume cubic centimeter (Mean)
Therapeutic37.5

Number of Participants With a Rise of Hydrogen <20 Parts Per Million Within 90 Minutes of Lactulose Ingestion.(Which is Considered Normal )

"Normalization of lactulose breath test as a potential predictor of improvement of rectal hypersensitivity will be evaluated by comparing lactulose breath test results pre- and post-treatment.~Normalization of lactulose breath test defined as rise of hydrogen <20 Parts per million within 90 minutes of lactulose ingestion.~patients with positive" (NCT03462966)
Timeframe: After completing 14-day course of rifaximin

InterventionParticipants (Count of Participants)
Therapeutic2

Reviews

29 reviews available for alosetron and Irritable Bowel Syndrome

ArticleYear
Current US Food and Drug Administration-Approved Pharmacologic Therapies for the Treatment of Irritable Bowel Syndrome with Diarrhea.
    Advances in therapy, 2020, Volume: 37, Issue:1

    Topics: Adult; Carbolines; Diarrhea; Female; Gastrointestinal Agents; Humans; Imidazoles; Irritable Bowel Sy

2020
Pharmacologic Treatments for Irritable Bowel Syndrome: an Umbrella Systematic Review.
    Journal of gastrointestinal and liver diseases : JGLD, 2020, Jun-03, Volume: 29, Issue:2

    Topics: Carbolines; Gastrointestinal Agents; Guanylyl Cyclase C Agonists; Humans; Irritable Bowel Syndrome;

2020
Current and emerging drug options in the treatment of diarrhea predominant irritable bowel syndrome.
    Expert opinion on pharmacotherapy, 2015, Volume: 16, Issue:18

    Topics: Antidepressive Agents, Tricyclic; Antidiarrheals; Carbolines; Diarrhea; Gastrointestinal Agents; Hum

2015
Rifaximin and eluxadoline - newly approved treatments for diarrhea-predominant irritable bowel syndrome: what is their role in clinical practice alongside alosetron?
    Expert opinion on pharmacotherapy, 2016, Volume: 17, Issue:3

    Topics: Abdominal Pain; Anti-Bacterial Agents; Carbolines; Diarrhea; Gastrointestinal Agents; Humans; Imidaz

2016
Emerging treatments in neurogastroenterology: eluxadoline - a new therapeutic option for diarrhea-predominant IBS.
    Neurogastroenterology and motility, 2016, Volume: 28, Issue:1

    Topics: Antidiarrheals; Carbolines; Diarrhea; Gastrointestinal Agents; Humans; Imidazoles; Irritable Bowel S

2016
Diarrhea-predominant irritable bowel syndrome: Diagnosis, etiology, and new treatment considerations.
    Journal of the American Association of Nurse Practitioners, 2016, Volume: 28, Issue:7

    Topics: Carbolines; Diarrhea; Disease Management; Humans; Imidazoles; Irritable Bowel Syndrome; Parasympatho

2016
Efficacy and tolerability of alosetron for the treatment of irritable bowel syndrome in women and men: a meta-analysis of eight randomized, placebo-controlled, 12-week trials.
    Clinical therapeutics, 2008, Volume: 30, Issue:5

    Topics: Carbolines; Female; Humans; Irritable Bowel Syndrome; Male; Randomized Controlled Trials as Topic; S

2008
Efficacy of 5-HT3 antagonists and 5-HT4 agonists in irritable bowel syndrome: systematic review and meta-analysis.
    The American journal of gastroenterology, 2009, Volume: 104, Issue:7

    Topics: Adult; Age Factors; Aged; Carbazoles; Carbolines; Dose-Response Relationship, Drug; Drug Administrat

2009
Alosetron for severe diarrhea-predominant irritable bowel syndrome: improving patient outcomes.
    Current medical research and opinion, 2011, Volume: 27, Issue:3

    Topics: Carbolines; Cost of Illness; Diarrhea; Female; Gastrointestinal Agents; Humans; Irritable Bowel Synd

2011
Peripherally acting therapies for the treatment of irritable bowel syndrome.
    Gastroenterology clinics of North America, 2011, Volume: 40, Issue:1

    Topics: Alprostadil; Antidiarrheals; Carbolines; Dietary Fiber; Dietary Supplements; Gastrointestinal Agents

2011
The risk of ischaemic colitis in irritable bowel syndrome patients treated with serotonergic therapies.
    Drug safety, 2011, Jul-01, Volume: 34, Issue:7

    Topics: Animals; Carbolines; Colitis, Ischemic; Female; Humans; Indoles; Irritable Bowel Syndrome; Male; Ser

2011
Quality of life in patients with irritable bowel syndrome.
    Journal of clinical gastroenterology, 2011, Volume: 45 Suppl

    Topics: Aged; Carbolines; Constipation; Diarrhea; Female; Gastrointestinal Agents; Health Status; Humans; Ir

2011
Evaluation of harm in the pharmacotherapy of irritable bowel syndrome.
    The American journal of medicine, 2012, Volume: 125, Issue:4

    Topics: Alprostadil; Antidepressive Agents, Tricyclic; Carbolines; Constipation; Diarrhea; Gastrointestinal

2012
Clinical trials in irritable bowel syndrome: a review.
    Reviews on recent clinical trials, 2013, Volume: 8, Issue:1

    Topics: Alprostadil; Benzamides; Biphenyl Compounds; Bridged Bicyclo Compounds, Heterocyclic; Carbolines; Do

2013
Alosetron in irritable bowel syndrome: strategies for its use in a common gastrointestinal disorder.
    Drugs, 2003, Volume: 63, Issue:18

    Topics: Carbolines; Clinical Trials as Topic; Contraindications; Female; Gastrointestinal Agents; Humans; Ir

2003
Alosetron and irritable bowel syndrome.
    Expert opinion on pharmacotherapy, 2003, Volume: 4, Issue:11

    Topics: Carbolines; Gastrointestinal Agents; Humans; Irritable Bowel Syndrome; Pain; Product Surveillance, P

2003
Advances in the management of irritable bowel syndrome.
    Current gastroenterology reports, 2003, Volume: 5, Issue:6

    Topics: Antidepressive Agents, Tricyclic; Carbolines; Cost of Illness; Desipramine; Evidence-Based Medicine;

2003
Reassessing the benefits and risks of alosetron: what is its place in the treatment of irritable bowel syndrome?
    Drug safety, 2004, Volume: 27, Issue:5

    Topics: Carbolines; Contraindications; Humans; Irritable Bowel Syndrome; Product Surveillance, Postmarketing

2004
Options for patients with irritable bowel syndrome: contrasting traditional and novel serotonergic therapies.
    Neurogastroenterology and motility, 2004, Volume: 16, Issue:6

    Topics: Animals; Antidepressive Agents; Antidiarrheals; Carbolines; Cathartics; Humans; Indoles; Intestines;

2004
Irritable bowel syndrome.
    Clinical evidence, 2004, Issue:11

    Topics: Adult; Aged; Antidepressive Agents; Carbolines; Dietary Fiber; Female; Gastrointestinal Agents; Huma

2004
Irritable bowel syndrome. 10% to 20% of older adults have symptoms consistent with diagnosis.
    Geriatrics, 2005, Volume: 60, Issue:1

    Topics: Aged; Carbolines; Diagnosis, Differential; Gastrointestinal Agents; Humans; Indoles; Irritable Bowel

2005
Pharmacological treatment of irritable bowel syndrome--from concept to sales.
    The European journal of surgery. Supplement. : = Acta chirurgica. Supplement, 2002, Issue:587

    Topics: Antidepressive Agents; Benzofurans; Carbolines; Cisapride; Constipation; Drug Industry; Gastrointest

2002
Incidence of ischemic colitis and serious complications of constipation among patients using alosetron: systematic review of clinical trials and post-marketing surveillance data.
    The American journal of gastroenterology, 2006, Volume: 101, Issue:5

    Topics: Carbolines; Clinical Trials as Topic; Colitis, Ischemic; Constipation; Diarrhea; Female; Gastrointes

2006
[Antagonists of the type 3 serotonin receptor (5 -HT3) in IBS].
    Nihon rinsho. Japanese journal of clinical medicine, 2006, Volume: 64, Issue:8

    Topics: Carbazoles; Carbolines; Female; Gastrointestinal Agents; Humans; Irritable Bowel Syndrome; Male; Pyr

2006
Irritable bowel syndrome: a practical review.
    Southern medical journal, 2006, Volume: 99, Issue:11

    Topics: Antidepressive Agents; Carbolines; Dietary Fiber; Food Hypersensitivity; Gastrointestinal Agents; Ga

2006
[Drug treatment of irritable bowel syndrome: an unmet need].
    Gastroenterologia y hepatologia, 2007, Volume: 30, Issue:3

    Topics: Abdominal Pain; Analgesics; Antidepressive Agents, Tricyclic; Antidiarrheals; Carbolines; Controlled

2007
[Novel therapeutic approaches in the treatment of irritable bowel syndrome].
    Orvosi hetilap, 2007, May-20, Volume: 148, Issue:20

    Topics: Adrenergic alpha-Agonists; Analgesics, Opioid; Anti-Bacterial Agents; Antidepressive Agents; Carboli

2007
Effects of 5-hydroxytryptamine (serotonin) type 3 antagonists on symptom relief and constipation in nonconstipated irritable bowel syndrome: a systematic review and meta-analysis of randomized controlled trials.
    Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2008, Volume: 6, Issue:5

    Topics: Administration, Oral; Carbazoles; Carbolines; Constipation; Diarrhea; Dose-Response Relationship, Dr

2008
Clinical practice. Irritable bowel syndrome.
    The New England journal of medicine, 2008, Apr-17, Volume: 358, Issue:16

    Topics: Adult; Antidepressive Agents, Tricyclic; Carbolines; Cognitive Behavioral Therapy; Desipramine; Fema

2008

Trials

7 trials available for alosetron and Irritable Bowel Syndrome

ArticleYear
Neural and psychological predictors of treatment response in irritable bowel syndrome patients with a 5-HT3 receptor antagonist: a pilot study.
    Alimentary pharmacology & therapeutics, 2008, Aug-01, Volume: 28, Issue:3

    Topics: Adult; Brain; Carbolines; Double-Blind Method; Female; Humans; Irritable Bowel Syndrome; Male; Pilot

2008
Randomised clinical trial: alosetron improves quality of life and reduces restriction of daily activities in women with severe diarrhoea-predominant IBS.
    Alimentary pharmacology & therapeutics, 2012, Volume: 36, Issue:5

    Topics: Activities of Daily Living; Adult; Carbolines; Constipation; Diarrhea; Dose-Response Relationship, D

2012
Effect of alosetron on bowel urgency and global symptoms in women with severe, diarrhea-predominant irritable bowel syndrome: analysis of two controlled trials.
    Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2004, Volume: 2, Issue:8

    Topics: Adult; Carbolines; Constipation; Defecation; Diarrhea; Female; Gastrointestinal Agents; Humans; Irri

2004
Long-term safety and efficacy of alosetron in women with severe diarrhea-predominant irritable bowel syndrome.
    The American journal of gastroenterology, 2004, Volume: 99, Issue:11

    Topics: Abdominal Pain; Carbolines; Chronic Disease; Diarrhea; Double-Blind Method; Female; Gastrointestinal

2004
A dose-ranging, phase II study of the efficacy and safety of alosetron in men with diarrhea-predominant IBS.
    The American journal of gastroenterology, 2005, Volume: 100, Issue:1

    Topics: Abdominal Pain; Adult; Aged; Aged, 80 and over; Carbolines; Diarrhea; Dose-Response Relationship, Dr

2005
The effects of the 5-HT3 antagonist, alosetron, on brain serotonin synthesis in patients with irritable bowel syndrome.
    Neurogastroenterology and motility, 2005, Volume: 17, Issue:2

    Topics: Brain; Carbolines; Female; Gastrointestinal Agents; Humans; Irritable Bowel Syndrome; Male; Positron

2005
A randomized, double-blind, placebo-controlled study to assess efficacy and safety of 0.5 mg and 1 mg alosetron in women with severe diarrhea-predominant IBS.
    The American journal of gastroenterology, 2007, Volume: 102, Issue:8

    Topics: Carbolines; Constipation; Diarrhea; Double-Blind Method; Drug Tolerance; Female; Gastrointestinal Ag

2007

Other Studies

31 other studies available for alosetron and Irritable Bowel Syndrome

ArticleYear
Discovery of a novel 5-HT(3) antagonist/5-HT(1A) agonist 3-amino-5,6,7,8-tetrahydro-2-{4-[4-(quinolin-2-yl)piperazin-1-yl]butyl}quinazolin-4(3H)-one (TZB-30878) as an orally bioavailable agent for irritable bowel syndrome.
    Journal of medicinal chemistry, 2010, Nov-11, Volume: 53, Issue:21

    Topics: Administration, Oral; Animals; Biological Availability; Brain; Cell Line; Cricetinae; Cricetulus; Gu

2010
Novel serotonin type 3 receptor partial agonists for the potential treatment of irritable bowel syndrome.
    Bioorganic & medicinal chemistry letters, 2011, Jan-01, Volume: 21, Issue:1

    Topics: Animals; Cell Line; Disease Models, Animal; Humans; Imidazoles; Indoles; Irritable Bowel Syndrome; M

2011
The discovery of diazepinone-based 5-HT3 receptor partial agonists.
    Bioorganic & medicinal chemistry letters, 2014, Jun-01, Volume: 24, Issue:11

    Topics: Administration, Oral; Animals; Azepines; Disease Models, Animal; Dose-Response Relationship, Drug; D

2014
Pharmacological evaluation of a novel corticotropin-releasing factor 1 receptor antagonist T-3047928 in stress-induced animal models in a comparison with alosetron.
    Neurogastroenterology and motility, 2020, Volume: 32, Issue:5

    Topics: Adrenocorticotropic Hormone; Animals; Carbolines; Conditioning, Classical; Defecation; Disease Model

2020
Alosetron versus traditional pharmacotherapy in clinical practice: effects on resource use, health-related quality of life, safety and symptom improvement in women with severe diarrhea-predominant irritable bowel syndrome.
    Current medical research and opinion, 2019, Volume: 35, Issue:3

    Topics: Adult; Aged; Carbolines; Diarrhea; Female; Health Resources; Humans; Imidazoles; Irritable Bowel Syn

2019
5-HT
    American journal of physiology. Gastrointestinal and liver physiology, 2019, 01-01, Volume: 316, Issue:1

    Topics: Animals; Carbolines; Disease Models, Animal; Humans; Hyperalgesia; Hypersensitivity; Irritable Bowel

2019
Specific alteration of rhythm in temperature-stressed rats possess features of abdominal pain in IBS patients.
    Journal of pharmacological sciences, 2015, Volume: 129, Issue:1

    Topics: Abdominal Pain; Animals; Carbolines; Cold Temperature; Disease Models, Animal; Duloxetine Hydrochlor

2015
Ischemic Colitis as a Complication of Medication Use: An Analysis of the Federal Adverse Event Reporting System.
    Digestive diseases and sciences, 2016, Volume: 61, Issue:9

    Topics: Adverse Drug Reaction Reporting Systems; Age Factors; Aged; Anti-Inflammatory Agents, Non-Steroidal;

2016
Transit time.
    Nature, 2016, 05-19, Volume: 533, Issue:7603

    Topics: Anti-Bacterial Agents; Biofeedback, Psychology; Carbolines; Colitis; Diet; Dysentery; Dyspepsia; Egy

2016
Drug development: A healthy pipeline.
    Nature, 2016, 05-19, Volume: 533, Issue:7603

    Topics: Animals; Benzimidazoles; Benzofurans; Bile Acids and Salts; Carbolines; Colesevelam Hydrochloride; C

2016
Board Review Vignette: Irritable Bowel Syndrome.
    The American journal of gastroenterology, 2016, Volume: 111, Issue:9

    Topics: Abdominal Pain; Adult; Anion Exchange Resins; Antidiarrheals; Carbolines; Cholestyramine Resin; Cons

2016
Alosetron for severe diarrhea-predominant irritable bowel syndrome: safety and efficacy in perspective.
    Expert review of gastroenterology & hepatology, 2010, Volume: 4, Issue:1

    Topics: Carbolines; Colitis, Ischemic; Constipation; Diarrhea; Dose-Response Relationship, Drug; Female; Hum

2010
Ischemic colitis and complications of constipation associated with the use of alosetron under a risk management plan: clinical characteristics, outcomes, and incidences.
    The American journal of gastroenterology, 2010, Volume: 105, Issue:4

    Topics: Adverse Drug Reaction Reporting Systems; Carbolines; Colitis, Ischemic; Constipation; Female; Humans

2010
Evaluation of treatment continuation with alosetron by IBS-D severity criteria.
    Current medical research and opinion, 2012, Volume: 28, Issue:3

    Topics: Adolescent; Adult; Aged; Carbolines; Diarrhea; Fecal Incontinence; Female; Follow-Up Studies; Gastro

2012
"Pre-cebo": an unrecognized issue in the interpretation of adequate relief during irritable bowel syndrome drug trials.
    Journal of clinical gastroenterology, 2012, Volume: 46, Issue:8

    Topics: Adult; Carbolines; Desipramine; Diarrhea; Female; Gastrointestinal Agents; Humans; Irritable Bowel S

2012
Irritable bowel syndrome genophenomics: correlation of serotonin-transporter polymorphisms and alosetron response.
    The pharmacogenomics journal, 2003, Volume: 3, Issue:2

    Topics: Carbolines; Carrier Proteins; Enteric Nervous System; Gastrointestinal Agents; Humans; Irritable Bow

2003
Study design issues in irritable bowel syndrome.
    Alimentary pharmacology & therapeutics, 2004, Jan-01, Volume: 19, Issue:1

    Topics: Carbolines; Double-Blind Method; Gastrointestinal Agents; Humans; Indoles; Irritable Bowel Syndrome;

2004
Platelet serotonin transporter in patients with diarrhea-predominant irritable bowel syndrome both before and after treatment with alosetron.
    The American journal of gastroenterology, 2003, Volume: 98, Issue:12

    Topics: Adult; Aged; Blood Platelets; Carbolines; Carrier Proteins; Diarrhea; Female; Humans; Irritable Bowe

2003
New options for soothing an irritable bowel.
    The Johns Hopkins medical letter health after 50, 2004, Volume: 16, Issue:1

    Topics: Carbolines; Diet; Dietary Fiber; Gastrointestinal Agents; Humans; Indoles; Irritable Bowel Syndrome;

2004
Therapy for irritable bowel syndrome.
    The New England journal of medicine, 2004, Mar-18, Volume: 350, Issue:12

    Topics: Carbolines; Humans; Indoles; Irritable Bowel Syndrome; Polypharmacy; Serotonin 5-HT3 Receptor Antago

2004
New drug for bothersome bowels.
    Health news (Waltham, Mass.), 2000, Volume: 6, Issue:4

    Topics: Carbolines; Female; Gastrointestinal Agents; Humans; Irritable Bowel Syndrome

2000
Comparison between partial agonist (ME3412) and antagonist (alosetron) of 5-hydroxytryptamine 3 receptor on gastrointestinal function.
    Neurogastroenterology and motility, 2005, Volume: 17, Issue:2

    Topics: Animals; Carbolines; Constipation; Diarrhea; Dogs; Gastrointestinal Motility; Gastrointestinal Tract

2005
Acute hepatitis associated with alosetron (Lotronex).
    Journal of clinical gastroenterology, 2005, Volume: 39, Issue:7

    Topics: Adult; Biopsy; Carbolines; Chemical and Drug Induced Liver Injury; Diagnosis, Differential; Female;

2005
Characterization of the metabolites of alosetron in experimental animals and human.
    Xenobiotica; the fate of foreign compounds in biological systems, 2005, Volume: 35, Issue:2

    Topics: Animals; Carbolines; Chromatography, High Pressure Liquid; Chromatography, Liquid; Dogs; Female; Gas

2005
Alosetron: ischemic colitis and serious complications of constipation.
    The American journal of gastroenterology, 2006, Volume: 101, Issue:5

    Topics: Carbolines; Colitis, Ischemic; Constipation; Gastrointestinal Agents; Humans; Irritable Bowel Syndro

2006
A patient follow-up survey programme for alosetron: assessing compliance to and effectiveness of the risk management programme.
    Alimentary pharmacology & therapeutics, 2006, Sep-01, Volume: 24, Issue:5

    Topics: Adolescent; Adult; Aged; Carbolines; Female; Follow-Up Studies; Gastrointestinal Agents; Humans; Irr

2006
Dual role of 5-HT3 receptors in a rat model of delayed stress-induced visceral hyperalgesia.
    Pain, 2007, Volume: 130, Issue:1-2

    Topics: Acute Disease; Analgesics, Non-Narcotic; Animals; Avoidance Learning; Capsaicin; Carbolines; Cathete

2007
The relationship between dosing of alosetron and discontinuation patterns reported by patients participating in a follow-up programme.
    Alimentary pharmacology & therapeutics, 2007, Feb-01, Volume: 25, Issue:3

    Topics: Adult; Aged; Carbolines; Female; Follow-Up Studies; Gastrointestinal Agents; Humans; Irritable Bowel

2007
Evaluation of the pharmacological profile of ramosetron, a novel therapeutic agent for irritable bowel syndrome.
    Journal of pharmacological sciences, 2007, Volume: 104, Issue:3

    Topics: Animals; Benzimidazoles; Carbazoles; Carbolines; Carrier Proteins; Colon; Defecation; Gastrointestin

2007
Effect of ramosetron on conditioned emotional stress-induced colonic dysfunction as a model of irritable bowel syndrome in rats.
    European journal of pharmacology, 2007, Nov-14, Volume: 573, Issue:1-3

    Topics: Animals; Behavior, Animal; Benzimidazoles; Carbazoles; Carbolines; Colon; Colonic Diseases, Function

2007
Balancing drug risk and benefit: toward refining the process of FDA decisions affecting patient care.
    The American journal of gastroenterology, 2008, Volume: 103, Issue:4

    Topics: Adverse Drug Reaction Reporting Systems; Carbolines; Clinical Trials as Topic; Drug Approval; Drug L

2008