Alosetron has been approved in the United States

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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alosetron studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
S3B30040 IV A Twelve-Week, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of 0.5mg QD, 1mg QD and 1mg BID of Alosetron in Female Subjects with Severe Diarrhea-predominant IBS Who Have Failed Conventional Therapy
S3B30048 IV 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
S3B40031 IV 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
S3B40032 IV 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
S3B40042 IV A Randomized, Placebo-Controlled, Crossover Study to Measure the Effect of Alosetron on Mucosal Blood Flow in Female Healthy Volunteers and Diarrhea-Predominant IBS Subjects
WE 138 IV Incidence of colonic ischemia, hospitalized complications of constipation, and bowel surgery in relation to use of alosetron hydrochloride
S3B30006 III A 1-Year Randomized, Double-Blind, Placebo-Controlled Study of Alosetron (GR68755) 1mg BID in Female Subjects With Irritable Bowel Syndrome
S3B30011 III 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
S3B30012 III A 6-Week Trial of Alosetron Hydrochloride 1mg Twice Daily as Empirical Therapy in Female Subjects With Symptoms of Non-Constipated Irritable Bowel Syndrome
S3B30013 III A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of Alosetron in Female Subjects With Alternating Diarrhea/Constipation Irritable Bowel Syndrome
S3B30015 III An 8-Week, Randomized, Double-Blind, Placebo-Controlled Study of Alosetron in Non-Constipated Adolescents With Irritable Bowel Syndrome
S3B30017 III 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
S3B30019 III A 16-week, Open-label, Safety Study of Alosetron in Non-Constipated Adolescents with Irritable Bowel Syndrome
S3B30020 III 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
S3B30025 III 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
S3B30026 III 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.
S3B30028 III 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
S3B30031 III 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
S3BA3001 III A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of Alosetron (GR68755) in Female Subjects With Irritable Bowel Syndrome
S3BA3002 III A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of Alosetron (GR68755) in Female Subjects With Irritable Bowel Syndrome
S3BA3003 III 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)
S3BB3001 III 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
S3BB3002 III 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
S3B20023 II 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
S3B20032 II 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
S3B-201 II 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
S3BA2001 II A 12-week, Dose-ranging, Double-blind, Placebo-controlled Study of Alosetron (GR68755) in Subjects with Irritable Bowel Syndrome
S3BA2002 II Characterization of Changes in Regional Brain Activity Associated With Sigmoid Sensitization in IBS Patients Using Positron Emission Tomography (PET) With and Without Alosetron Therapy
S3BP12 II A Double-Blind Placebo-Controlled Study to Determine the Efficacy of GR68755C (Alosetron) in Treatment of Irritable Bowel Syndrome
AS-03 I Alosetron (GR68755): Phase I study (evaluation of the effect of food in healthy volunteer).
C92-006 I To assess the effects of GR68755C on psychological and psychomotor responses to amphetamine in healthy volunteers.
C92-058 I An investigation of the gender differences in the pharmacokinetics of GR68755C.
GHP:89:17 I A study to evaluate the effects of GR68755 on memory and information processing when co-administered with scopolamine in young healthy volunteers
GHP:89:23 I Initial safety and tolerability study with intravenous GR68755 in human volunteers.
GHP:89:38 I Initial safety and tolerability study with oral doses of GR68755 in human volunteers.
GHP:90:27 I A study to investigate the duration of effect of oral GR68755 on intradermal 5-HT induced flare response in volunteers
S3B10903 I 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
S3B10932 I 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.
S3B10934 I 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
S3B10935 I 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.
S3B10936 I 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.
S3B10937 I 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.
S3B10938 I 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.
S3B10939 I 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.
S3B10942 I An open-label study of the pharmacokinetics of a single 1mg oral dose of alosetron in healthy Korean subjects.
S3B10945 I 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
S3B10946 I 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.
S3B10947 I 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
S3B10948 I 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
S3B40040 I A Double-Blind, Placebo-Controlled, Randomised, 2-Way Crossover Study to Evaluate the Potential Inhibition of Alosetron Metabolism by Ketoconazole in Healthy Female Subjects
S3B40041 I A Double-Blind, Placebo-Controlled, Randomised, 2-Way Crossover Study to Evaluate the Potential Inhibition of Alosetron Metabolism by Fluvoxamine in Healthy Female Subjects
S3BA1001 I 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.
S3BA1002 I An Open-Label, Non-Randomized, Two-Period Crossover, Drug-Drug Interaction Study to Compare the Pharmacokinetics of MIN-OVRAL (150mg levonorgestrel and 30mg ethinyl estradiol) in Healthy Female Subjects When Administered Alone for 21 Days, and Following Co-Administration of Alosetron 1mg bid Orally for 21 Days.
S3BA1003 I 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.
S3BA1004 I 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.
S3BA1006 I 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
S3BB1002 I 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)
S3BB1004 I A study to determine the effects of food on the pharmacokinetics of oral alosetron in healthy volunteers.
S3BB1010 I 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.
S3BB1011 I The pharmacokinetics of alosetron 1 mg bid oral administration for 29 days in healthy subjects.
S3BB2011 I A study to investigate the effects of alosetron on gastrointestinal transit time and rectal sensation in patients with irritable bowel syndrome (IBS).
S3BH02 I 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.