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A Study of 3 Doses of Dextofisopam in Females With Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00486876
Recruitment Status : Completed
First Posted : June 15, 2007
Last Update Posted : August 2, 2011
Sponsor:
Information provided by:
Pharmos

Tracking Information
First Submitted Date  ICMJE June 13, 2007
First Posted Date  ICMJE June 15, 2007
Last Update Posted Date August 2, 2011
Study Start Date  ICMJE June 2007
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2009)
The percentage of weeks for which patients record adequate overall relief of IBS symptoms during the double blind period (12 weeks of treatment). [ Time Frame: June 07 thru August 09 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 14, 2007)
The percentage of weeks for which patients record overall adequate relief of IBS symptoms during the double blind period. [ Time Frame: On a weekly basis during the 12 week double blind period ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2007)
Number of months and weeks of adequate relief of pain or discomfort and of abnormal bowel habits and proportion of patients who had tghis weekly or monthly relief. [ Time Frame: weekly and monthly during the double bind period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of 3 Doses of Dextofisopam in Females With Irritable Bowel Syndrome
Official Title  ICMJE A Double-Blind, Randomized, Placebo-Controlled Phase 2b Study of 100, 200, and 300 mg BID Dextofisopam in Female Outpatients With Irritable Bowel Syndrome
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 and/or 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 events(AE's) and filling out the IBS Quality of Life Questionnaire( IBSQOL ), the Work Productivity and Activity Impairment Questionnaire-IBS Version ( WPAI:IBS )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, AE's, concomitant medications and daily and weekly symptom assessment via IVRS will be recorded.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE Drug: Dextofisopam
capsules, 0 (placebo), 100, 200, and 300 mg BID for 12 weeks
Study Arms  ICMJE
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: Dextofisopam
  • Experimental: 2
    100 mg BID
    Intervention: Drug: Dextofisopam
  • Experimental: 3
    200 mg BID
    Intervention: Drug: Dextofisopam
  • Experimental: 4
    300 mg BID
    Intervention: Drug: Dextofisopam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 23, 2009)
324
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2007)
480
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Female

Inclusion Criteria:

  • 1. Outpatient post-menopausal or no pregnant females,18 to 65 years old
  • 2. Irritable bowel syndrome, which meet the Rome III criteria for IBS of the diarrhea-predominant or the alternating subtype
  • 3. Able to give informed consent
  • 4 Willingness to make daily calls on a touch-tone telephone

Exclusion Criteria:

  • 1. Clinically significant abnormality on the screening tests.
  • 2. Use of any other investigational drug within 30 days before screening visit.
  • 3. Serious underlying diseases, including psychiatric disorders or current history of conditions affecting bowel habits
  • 4. Previous treatment with tofisopam Related drugs.
  • 5. History or presence of clinically significant medical disease that might compromise the study or be detrimental to the patient, such as
  • 6. Subject has exclusively constipation-predominant IBS.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00486876
Other Study ID Numbers  ICMJE VPI-TOFP-203
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party President, Pharmos Corporation
Study Sponsor  ICMJE Pharmos
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: S Colin Neill President and CFO, Pharmos
PRS Account Pharmos
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP