Home > Result Summaries: Compounds > alosetron Result Summaries: alosetron GSKStudy ID Phase Title Summary (Download) 114591 N/A Incidence of colonic ischemia, hospitalized complications of constipation, and bowel surgery in relation to use of alosetron hydrochloride (1 citation(s)) C92-058 Phase 1 An investigation of the gender differences in the pharmacokinetics of GR68755C. (1 citation(s)) S3B10903 Phase 1 An Open-Label, Non-Randomized, Single-Dose Study of the Pharmacokinetics of Alosetron 1mg in Children 6-11 Years of Age With Non-Constipated Irritable Bowel Syndrome (2 citation(s)) S3B10909 Phase 1 Alosetron (GR68755): Phase I study (evaluation of the effect of food in healthy volunteer). (0 citation(s)) S3B10910 Phase 1 To assess the effects of GR68755C on psychological and psychomotor responses to amphetamine in healthy volunteers. (0 citation(s)) S3B10916 Phase 1 A study to evaluate the effects of GR68755 on memory and information processing when co-administered with scopolamine in young healthy volunteers (0 citation(s)) S3B10917 Phase 1 Initial safety and tolerability study with intravenous GR68755 in human volunteers. (0 citation(s)) S3B10919 Phase 1 Initial safety and tolerability study with oral doses of GR68755 in human volunteers. (0 citation(s)) S3B10924 Phase 1 A study to investigate the duration of effect of oral GR68755 on intradermal 5-HT induced flare response in volunteers (0 citation(s)) S3B10932 Phase 1 A double-blind, randomized-step study of the effect of alosetron 1 mg, 2 mg, and 4 mg BID versus placebo on QT and QTc following 4 days of administration in healthy females. (0 citation(s)) S3B10934 Phase 1 An Open-Label, Non-Randomized, Single-Dose Study of the Pharmacokinetics of Alosetron 1mg in Adolescents 12-17 Years of Age With Non-Constipated Irritable Bowel Syndrome (0 citation(s)) S3B10935 Phase 1 An open-label, non-randomized, two-way cross-over trial to evaluate the effect of multiple-dose alosetron administration (1 mg PO BID for 14 days) on the pharmacokinetics of single-dose fluoxetine (PROZAC) administration in healthy subjects. (1 citation(s)) S3B10936 Phase 1 An open-label, non-randomized, cross-over trial to evaluate the effect of alosetron (1 mg PO BID for 5 days) on the pharmacokinetics of single-dose amitriptyline (Elavil) administration in healthy subjects. (0 citation(s)) S3B10937 Phase 1 An open-label, single-dose, randomized, two-period, cross-over trial to evaluate the effect of alosetron (1 mg PO) on the pharmacokinetics of hydrocodone and acetaminophen (VICODIN 5 mg/ 500 mg PO) in healthy subjects. (0 citation(s)) S3B10938 Phase 1 An open-label, randomized, two-period, cross-over trial to evaluate the effect of alosetron (1 mg PO BID for 2 days) on the pharmacokinetics of single-dose alprazolam (1 mg PO) in healthy subjects. (1 citation(s)) S3B10939 Phase 1 An open-label, single-dose, randomized, two-period cross-over trial to evaluate the effect of alosetron administration (1 mg PO) on the pharmacokinetics of ibuprofen (600 mg PO) administration in healthy subjects. (0 citation(s)) S3B10940 Phase 1 A randomised, double-blind, placebo-controlled, cross-over study to investigate the effect of alosetron (GR68755C) on basal jejunal water and electrolyte transport in healthy male subjects. (0 citation(s)) S3B10942 Phase 1 An open-label study of the pharmacokinetics of a single 1mg oral dose of alosetron in healthy Korean subjects. (0 citation(s)) S3B10945 Phase 1 A Double-Blind, Randomised, 2-Way Crossover Study to Determine the Effect of Alosetron 1mg BID for 14 days Versus Placebo BID on Visceral Hypersensitivity Following Duodenal Lipid Infusion in Female Diarrhea-Predominant IBS Patients (0 citation(s)) S3B10946 Phase 1 An open-label parallel-group, pharmacokinetics and tolerability study of a single 1mg oral dose of alosetron in hepatically impaired subjects and in healthy control subjects. (0 citation(s)) S3B10947 Phase 1 An Open-Label, Non-Randomized, Mass Balance Study to Characterize the Metabolism of Isotopically Labelled Alosetron After a Single 4mg Oral Dose of [13C, 14C]-Alosetron in Healthy Subjects (0 citation(s)) S3B10948 Phase 1 An open-label, Within-Subject Study to Compare the Pharmacodynamics and Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel 100mg and Ethinyl Estradiol 20mg in Healthy Female Subjects When Administered Alone and Following Co-Administration of Alosetron 1mg BID Orally for 28 Days (1 citation(s)) S3B20019 Phase 2 A randomized, double-blind, placebo-controlled, crossover evaluation of the effects of GR68755C on plasma levels of haloperidol in patients with a diagnosis of schizophrenia. (0 citation(s)) S3B20023 Phase 2 A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging, Phase II Study to Assess the Clinical Efficacy of Alosetron (GR68755) in Male Subjects With Irritable Bowel Syndrome (3 citation(s)) S3B20032 phase 2 A four-week, open, multicenter study to assess the safety and efficacy of 1 mg once daily (QD) of GR68755 in female subjects with severe diarrhea-predominant irritable bowel syndrome (IBS) who have frequent bowel urgency (0 citation(s)) S3B30006 Phase 3 A 1-Year Randomized, Double-Blind, Placebo-Controlled Study of Alosetron (GR68755) 1mg BID in Female Subjects With Irritable Bowel Syndrome (1 citation(s)) S3B30011 Phase 3 A Twelve Week Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Tolerability of Alosetron Hydrochloride 1mg Twice Daily for Control of Bowel Urgency in Females with Nonconstipated Irritable Bowel Syndrome (9 citation(s)) S3B30012 Phase 3 A 6-Week Trial of Alosetron Hydrochloride 1mg Twice Daily as Empirical Therapy in Female Subjects With Symptoms of Non-Constipated Irritable Bowel Syndrome (1 citation(s)) S3B30013 Phase 3 A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of Alosetron in Female Subjects With Alternating Diarrhea/Constipation Irritable Bowel Syndrome (2 citation(s)) S3B30015 Phase 3 An 8-Week, Randomized, Double-Blind, Placebo-Controlled Study of Alosetron in Non-Constipated Adolescents With Irritable Bowel Syndrome (0 citation(s)) S3B30017 Phase 3 A Multi-Centre Study to Determine the Efficacy and Safety of Alosetron 2mg BID in Female Subjects With Diarrhoea-Predominant Irritable Bowel Syndrome who do not Respond to Treatment With Alosetron 1mg BID (0 citation(s)) S3B30019 Phase 3 A 16-week, Open-label, Safety Study of Alosetron in Non-Constipated Adolescents with Irritable Bowel Syndrome (0 citation(s)) S3B30020 Phase 3 A 24-Week Randomized, Open Label Study of Healthcare Resource Use, Quality of Life, and Productivity With Alosetron 1mg Twice Daily Versus Traditional Therapy in Females with Irritable Bowel Syndrome Whose Predominant Bowel Symptom is Diarrhea (2 citation(s)) S3B30025 Phase 3 A 24-Week Randomised, Double-Blind, Placebo-Controlled Study of Quality of Life With Alosetron 1mg bd Versus Placebo in Females With Non-Constipated Irritable Bowel Syndrome (0 citation(s)) S3B30026 Phase 3 8-Week, Multicenter, Randomized Double-Blind Trial on Nonconstipated Patients with Irritable Bowel Syndrome Treated with 1mg Alosetron Twice A Day Compared to 2mg Alosetron Once A Day. (0 citation(s)) S3B30028 Phase 3 An International, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Study of Alosetron 1mg BID in Female Subjects With Diarrhoea-Predominant Irritable Bowel Syndrome Within Asia Pacific (0 citation(s)) S3B30031 Phase 3 An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Study of Alosetron in Female Subjects With Non-Constipated Irritable Bowel Syndrome Who Show Therapeutic Response to Alosetron (0 citation(s)) S3B30040 phase 3 A Twelve-Week, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of 0.5 mg QD, 1 mg QD and 1 mg BID of Alosetron in Female Subjects with Severe Diarrhea-predominant IBS Who Have Failed Conventional Therapy (0 citation(s)) S3B30048 phase 3 A 12-Week, Randomized, Double-Blind, Placebo- Controlled Study of PRN BID and Fixed Dosing Regimens of Alosetron in Female Subjects with Severe Diarrhea-Predominant Irritable Bowel Syndrome Who Have Failed Conventional Therapy (0 citation(s)) S3B40031 Phase 4 A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Tolerability of Alosetron Hydrochloride 1mg Twice Daily for Control of Bowel Urgency in Females with Non-constipated Irritable Bowel Syndrome in an Independent Practitioner Association (IPA) Model (6 citation(s)) S3B40032 Phase 4 An Observational Study to Assess Prevalence, Natural History, and Burden of Illness of Irritable Bowel Syndrome (IBS) in Clinical Practice and to Evaluate the Impact of Alosetron Treatment on Natural History and Burden of Illness in a Cohort of Females Whose Predominant Bowel Symptom is Diarrhea (6 citation(s)) S3B40040 Phase 4 A Double-Blind, Placebo-Controlled, Randomised, 2-Way Crossover Study to Evaluate the Potential Inhibition of Alosetron Metabolism by Ketoconazole in Healthy Female Subjects (0 citation(s)) S3B40041 Phase 4 A Double-Blind, Placebo-Controlled, Randomised, 2-Way Crossover Study to Evaluate the Potential Inhibition of Alosetron Metabolism by Fluvoxamine in Healthy Female Subjects (0 citation(s)) S3B40042 Phase 4 A randomize, placebo-controlled, crossover study to measure the effect of alosetron on mucosal blood flow in female healthy volunteers and diarrhea-predominant IBS subjects (0 citation(s)) S3BA1001 Phase 1 A Randomised, Placebo-Controlled, Repeat Dose, Double-Blind Two-Period, Cross-over Study to Compare ECG Changes and Pharmacokinetics of Cisapride Following 4 Days of Dosing With Cisapride 20mg QID with Placebo and with Alosetron 1mg BID in Healthy Male and Female Volunteers. (0 citation(s)) S3BA1002 Phase 1 An Open-Label, Non-Randomized, Two-Period Crossover, Drug-Drug Interaction Study to Compare the Pharmacokinetics of MIN-OVRAL in Healthy Female Subjects When Administered Alone for 21 Days, and Following Co-Administration of Alosetron 1mg bid Orally for 21 Days. (0 citation(s)) S3BA1003 Phase 1 A randomised, open label, two-way cross-over trial to evaluate colonic transit times following one week of mebeverine 135 mg tds plus alosetron 1 mg bd versus alosetron 1 mg bd in healthy female volunteers. (0 citation(s)) S3BA1004 Phase 1 A Randomized, Double-Blind, Placebo-Controlled, Repeat Dose, Two Period, Crossover Study to evaluate the effect of alosetron (1mg po BID) on theophylline (THEO-DUR 200mg po BID) pharmacokinetics in healthy female volunteers. (1 citation(s)) S3BA1006 Phase 1 A Double-Blind, Randomized, Placebo-Controlled, 2-Way Crossover Study to Determine the Effect of Alosetron 1mg BID on Cholecystokinin-Induced Colonic Motility and Abdominal Pain in IBS Patients (0 citation(s)) S3BA2001 Phase 2 A 12-week, Dose-ranging, Double-blind, Placebo-controlled Study of Alosetron (GR68755) in Subjects with Irritable Bowel Syndrome (2 citation(s)) S3BA2002 Phase 2 Characterization of Changes in Regional Brain Activity Associated With Sigmoid Sensitization in IBS Patients Using Positron Emission Tomography (PET) With and Without Alosetron Therapy (3 citation(s)) S3BA3001 Phase 3 A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of Alosetron (GR68755) in Female Subjects With Irritable Bowel Syndrome (3 citation(s)) S3BA3002 Phase 3 A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of Alosetron (GR68755) in Female Subjects With Irritable Bowel Syndrome (3 citation(s)) S3BA3003 Phase 3 A 12-Month Randomized, Double-blind, Placebo-controlled Study to Evaluate the Quality of Life and Safety Associated with the Long-term Use of Alosetron (GR68755) in Subjects with Irritable Bowel Syndrome (Final Analysis) (1 citation(s)) S3BB1002 Phase 1 A Study to Investigate the Effect of Alosetron (4mg), BID for 7½ Days, on 24-Hour Small Bowel Motility, in Patients With Irritable Bowel Syndrome (IBS) (0 citation(s)) S3BB1004 Phase 1 A study to determine the effects of food on the pharmacokinetics of oral alosetron in healthy volunteers. (0 citation(s)) S3BB1010 Phase 1 Report of a study to compare the pharmacokinetics of, and tolerability to, a single, oral, 1 mg dose of alosetron in healthy subjects and subjects with renal impairment not requiring dialysis. (0 citation(s)) S3BB1011 Phase 1 The pharmacokinetics of alosetron 1 mg bid oral administration for 29 days in healthy subjects. (1 citation(s)) S3BB2009 Phase 2 A Double-Blind Placebo-Controlled Study to Determine the Efficacy of GR68755C (Alosetron) in Treatment of Irritable Bowel Syndrome (1 citation(s)) S3BB2011 Phase 1 A study to investigate the effects of alosetron on gastrointestinal transit time and rectal sensation in patients with irritable bowel syndrome (IBS). (3 citation(s)) S3BB3001 Phase 3 A Multicentre, Randomised, Double-blind Comparison of Alosetron 1mg bd against Mebeverine 135mg tds for 12 Weeks in the Treatment of Female Patients with Irritable Bowel Syndrome (2 citation(s)) S3BB3002 Phase 3 A Multicentre, Randomised, Double-Blind Comparison of Alosetron 1mg bd against Trimebutine 200mg tds for 12 weeks in the Treatment of Female Patients with Irritable Bowel Syndrome. (1 citation(s))
