Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00486876
Status:
COMPLETED
Last Update Posted:
2011-08-02
First Post:
2007-06-13
Brief Title:
A Study of 3 Doses of Dextofisopam in Females With Irritable Bowel Syndrome
Sponsor:
Pharmos
Organization:
Pharmos
Study Overview
Official Title:
A Double-Blind Randomized Placebo-Controlled Phase 2b Study of 100 200 and 300 mg BID Dextofisopam in Female Outpatients With Irritable Bowel Syndrome
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objectives of this study are to evaluate the clinical safety and tolerability and to assess the efficacy of 100 mg 200 mg and 300 mg BID dextofisopam compared with placebo in female outpatients with diarrhea-predominant or alternating irritable bowel syndrome IBS
Detailed Description:
This is a double-blind randomized placebo-controlled Phase 2b study of the safety tolerability and efficacy of 100 200 and 300 mg BID dextofisopam in female patients suffering from diarrhea-predominant or alternating-Irritable Bowel Syndrome d-IBS or a-IBS Approximately 120 patients will be enrolled in each of the 4 arms of the study which will be conducted in up to 70 clinical sites in the USA The patients will be stratified by diagnosis
Outpatient females 18 to 65 years old will be enrolled in the study if diagnosed with d-IBS or a-IBS after having been screened during up to 17 days prior to enrollment including colonoscopy if not done within the last 5 years and found to have no organic disease that might have caused their complaints of abdominal pain or discomfort which when started was associated with a change in stool frequency or form andor improves with defecation
Patients will be instructed to take 3 capsules of the blinded study drug twice a day by mouth and to record by an interactive voice response system IVRS any change in their symptoms Patients who meet all the Inclusion and Exclusion criteria will be evaluated at baseline one day prior to taking study drug including laboratory determinations including a pregnancy test for women of childbearing potential vital signs electrocardiogram ECG recording of adverse eventsAEs and filling out the IBS Quality of Life Questionnaire IBSQOL the Work Productivity and Activity Impairment Questionnaire-IBS Version WPAIIBS and the Hospital l Anxiety and Depression Questionnaire HAD
Enrolled patients will have 12 weeks of double-blind treatment followed by a 28 day post treatment period
Symptoms will be recorded daily
Patients will visit the investigating site at weeks 4 8 and 12 after the baseline visit and the procedures performed at baseline will be repeated A post treatment visit will occur 28 days after discontinuing study drug Vital signs AEs concomitant medications and daily and weekly symptom assessment via IVRS will be recorded
Outpatient females 18 to 65 years old will be enrolled in the study if diagnosed with d-IBS or a-IBS after having been screened during up to 17 days prior to enrollment including colonoscopy if not done within the last 5 years and found to have no organic disease that might have caused their complaints of abdominal pain or discomfort which when started was associated with a change in stool frequency or form andor improves with defecation
Patients will be instructed to take 3 capsules of the blinded study drug twice a day by mouth and to record by an interactive voice response system IVRS any change in their symptoms Patients who meet all the Inclusion and Exclusion criteria will be evaluated at baseline one day prior to taking study drug including laboratory determinations including a pregnancy test for women of childbearing potential vital signs electrocardiogram ECG recording of adverse eventsAEs and filling out the IBS Quality of Life Questionnaire IBSQOL the Work Productivity and Activity Impairment Questionnaire-IBS Version WPAIIBS and the Hospital l Anxiety and Depression Questionnaire HAD
Enrolled patients will have 12 weeks of double-blind treatment followed by a 28 day post treatment period
Symptoms will be recorded daily
Patients will visit the investigating site at weeks 4 8 and 12 after the baseline visit and the procedures performed at baseline will be repeated A post treatment visit will occur 28 days after discontinuing study drug Vital signs AEs concomitant medications and daily and weekly symptom assessment via IVRS will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None