A Dose-Ranging, Phase II Study of the Efficacy and Safety of Alosetron in Men with Diarrhea-Predominant IBS

Chang, Lin; Ameen, Vanessa Z.; Dukes, George E.; McSorley, David; Carter, Eric G.; Mayer, Emeran A.

doi:10.1111/j.1572-0241.2005.40365.x

Cited by 116 publications

(93 citation statements)

References 32 publications

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“…In the recently reported phase II study of alosetron in men with D-IBS, the effect of alosetron was not clear compared to female results [14]. On the other hand, cilansetron, another 5-HT 3 receptor antagonist, was shown to be effective in both males and females [13] in the phase III clinical trial.…”

Section: Discussionmentioning

confidence: 99%

A Phase II Trial of the Novel Serotonin Type 3 Receptor Antagonist Ramosetron in Japanese Male and Female Patients with Diarrhea-Predominant Irritable Bowel Syndrome

Matsueda

Harasawa²,

Hongo

et al. 2008

Digestion

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Background: Irritable bowel syndrome (IBS) is a common gastrointestinal disorder. Serotonin type 3 (5-HT₃) receptor antagonist alosetron hydrochloride is indicated for women with chronic, severe diarrhea-predominant IBS who have not responded adequately to conventional therapy. However, whether or not the therapeutic efficacy of 5-HT₃ receptor antagonists has gender difference is uncertain. Methods: A double-blind, placebo-controlled, parallel-group, comparative study was conducted to evaluate the effect of novel 5-HT₃ receptor antagonist, ramosetron hydrochloride, in male and female patients with diarrhea-predominant IBS. 418 subjects were randomized (109 subjects: placebo, 105 subjects: 1 µg, 103 subjects: 5 µg, and 101 subjects: 10 µg) and administered the study drug once daily. Results: The monthly responder rates of ‘Patient-reported global assessment of relief of irritable bowel syndrome symptoms’ in the 5- and 10-µg ramosetron hydrochloride-administered groups were higher than the placebo group (26.92, 42.57, and 43.01% for placebo, 5 and 10 µg). Moreover, the difference of the responder rate in comparison with the placebo group was similar in males and females. As for safety, there was tolerability at doses up to 10 µg. Conclusion: Ramosetron is an effective and well-tolerated treatment not only for female IBS patients but also for male patients.

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Section: Discussionmentioning

confidence: 99%

A Phase II Trial of the Novel Serotonin Type 3 Receptor Antagonist Ramosetron in Japanese Male and Female Patients with Diarrhea-Predominant Irritable Bowel Syndrome

Matsueda

Harasawa²,

Hongo

et al. 2008

Digestion

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“…Patients with IBS frequently show exaggerated gastrointestinal motility under stress (Fukudo et al 1993), have psychiatric comorbidities, especially depressive disorders, anxiety disorders, and somatoform disorders (Drossman 2006), and reveal psychosocial risk factors including sexual/physical abuse, economical loss, and social withdrawal (Drossman 2006). Although several new pharmacological agents for IBS have been developed (Camilleri et al 2000;Chey et al 2004;Chang et al 2005;Tack et al 2005;Reilly et al 2005), there are still patients who do not respond to pharmacotherapy (Levy et al 2006). For these patients, psychotherapy might be useful.…”

Section: Introductionmentioning

confidence: 98%

Effect of Autogenic Training on General Improvement in Patients with Irritable Bowel Syndrome: A Randomized Controlled Trial

Shinozaki

Kanazawa

Kano

et al. 2009

Appl Psychophysiol Biofeedback

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Autogenic training (AT) is a useful and comprehensive relaxation technique. However, no studies have investigated the effects of AT on irritable bowel syndrome (IBS). In this study we tested the hypothesis that AT improves symptoms of IBS. Twenty-one patients with IBS were randomly assigned to AT (n = 11, 5 male, 6 female) or control therapy (n = 10, 5 male, 5 female). AT patients were trained intensively, while the control therapy consisted of discussions about patients' meal habits and life styles. All patients answered a question related to adequate relief (AR) of IBS symptoms and four questionnaires: Self-induced IBS Questionnaire (SIBSQ), Self-reported Depression Scale (SDS), State-Trait Anxiety Inventory (STAI), and Medical Outcome Short Form 36 Health Survey (SF-36). The proportion of AR in the last AT session in the AT group (9/11, 81.8%) was significantly higher than that in the controls (3/10, 30.0%, Chi-square test, p = 0.048). Two subscales of the SF-36, i.e., social functioning and bodily pain, were significantly improved in the AT group (p < 0.05) as compared to the control group. Role emotional (p = 0.051) and general health (p = 0.068) showed a tendency for improvement in the AT group. AT may be useful in the treatment of IBS by enhancing self-control.

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“…While the therapeutic gain associated with 5-HT3 antagonists [54][55][56][57][58][59][60][61][62] and 5-HT4 agonists [63][64][65][66][67][68][69][70][71][72] in treatment of sporadic IBS has been small, patients with PI-IBS are relatively more homogeneous and might demonstrate enhanced efficacy.…”

Section: Therapymentioning

confidence: 99%

Post-infectious irritable bowel syndrome

Thabane¹,

Marshall²

2009

WJG

148

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Post-infectious irritable bowel syndrome (PI-IBS) is a common disorder wherein symptoms of IBS begin after an episode of acute gastroenteritis. Published studies have reported incidence of PI-IBS to range between 5% and 32%. The mechanisms underlying the development of PI-IBS are not fully understood, but are believed to include persistent sub-clinical inflammation, changes in intestinal permeability and alteration of gut flora. Individual studies have suggested that risk factors for PI-IBS include patients' demographics, psychological disorders and the severity of enteric illness. However, PI-IBS remains a diagnosis of exclusion with no specific disease markers and, to date, no definitive therapy exists. The prognosis of PI-IBS appears favorable with spontaneous and gradual resolution of symptoms in most patients.

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A Dose-Ranging, Phase II Study of the Efficacy and Safety of Alosetron in Men with Diarrhea-Predominant IBS

Abstract: Alosetron 1 mg twice daily provided adequate relief of IBS pain and discomfort, and improved stool consistency in men with diarrhea-predominant IBS.

Cited by 116 publications

References 32 publications

A Phase II Trial of the Novel Serotonin Type 3 Receptor Antagonist Ramosetron in Japanese Male and Female Patients with Diarrhea-Predominant Irritable Bowel Syndrome

A Phase II Trial of the Novel Serotonin Type 3 Receptor Antagonist Ramosetron in Japanese Male and Female Patients with Diarrhea-Predominant Irritable Bowel Syndrome

Effect of Autogenic Training on General Improvement in Patients with Irritable Bowel Syndrome: A Randomized Controlled Trial

Post-infectious irritable bowel syndrome

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