Back to resultsA Study of 3 Doses of Dextofisopam in Females With Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dextofisopam
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable bowel syndrome, Diarrhea predominant Irritable Bowel Syndrome, Alternating Irritable Bowel Syndrome
Eligibility Criteria
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.
Sites / Locations
- Alliance Clinical Research
- Clinical Research Associates
- Mobile Medical and Diagnostic Center
- Radiant Research, Phoenix Southwest
- Mayo Clinic Arizona
- Arkansas Gastroenterology
- Providence Clinical Research
- Discovery Clinical Research
- Digestive and Liver Disease Specialists
- Community Clinical Trials
- Advance Clinical Research Institute
- Northern California Research
- Medical Associates Research Group
- Westlake Medical Research
- Lynn Institute of the Rockies
- Rx Clinical Trials
- Meridien Research
- Borland-Groover Clinic
- Genesis Research International
- Well Pharma Medical Research, Corp.
- Renstar Medical Research
- Compass Research, LLC
- The Clinical Research Center of Northwest Florida
- ACCORD Clinical Research, LLC
- Meridien Research
- Palm Beach Research Center
- Mount Vernon Clinical Research
- Perimeter Institute for Clinical Research, Inc. (PICR)
- North Georgia Clinical Research
- Rosemark Women Care Specialists
- Rockford Gastroenterology Associates
- Heartland Research Associates, LLC
- Heartland Research Associates
- Trover Health System
- Clinical Trials of America
- Maryland Digestive Disease Research, LLC
- Capital Gastroenterology Consultants, PA
- University of Michigan
- Gastrointestinal Associates
- Meridan Clinical Research
- Digestive Disease Specialists
- New Mexico Clinical Research & Osteoporosis Center, Inc
- Long Island Clinical Research Associates
- Long Island Gastrointestinal Research Group
- Winthrop University Hospital
- The Weill Medical College Of Cornell University
- Asheville Gastroenterology Associates
- Cumberland Research Associates, LLC.
- Clinical Trials of America, Inc.
- Clinical Trials of America
- Medical Frontiers, LLC
- Consultants for Clinical Research
- Digestive Health Network
- Gastroenterology Research Consultants of Greater Cincinnati
- Rapid Medical Research, Inc.
- Gastrointestinal & Liver Diseases Consultants, PC
- Toledo Center for Clinical Research
- Family Practice Center of Wadsworth, Inc.
- Lynn Institute of Norman
- Lynn Health Science Institute
- Aquilo Research
- TriValley Primary Care-Pennridge
- Coastal Carolina Research Center
- TriCities Medical Research
- ClinSearch
- Memphis Gastroenterology Group
- Gastroenterology Associates
- Austin Gastroenterology, PA
- Radiant Research of Dallas-North
- Research Across America
- Sun Research Institute
- Quality Research, Inc.
- Gastroenterology Clinic of San Antonio
- Advanced Research Institute
- Gastroenterology Associates of Tidewater
- Professional Place Medical Group, LLC
- New River Valley Research Institute
- National Clinical Recruiters, Inc
- Wenatchee Valley Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
Placebo
100 mg BID
200 mg BID
300 mg BID
Outcomes
Primary Outcome Measures
The percentage of weeks for which patients record adequate overall relief of IBS symptoms during the double blind period (12 weeks of treatment).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00486876
Brief Title
A Study of 3 Doses of Dextofisopam in Females With Irritable Bowel Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pharmos
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable bowel syndrome, Diarrhea predominant Irritable Bowel Syndrome, Alternating Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
324 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
100 mg BID
Arm Title
3
Arm Type
Experimental
Arm Description
200 mg BID
Arm Title
4
Arm Type
Experimental
Arm Description
300 mg BID
Intervention Type
Drug
Intervention Name(s)
Dextofisopam
Intervention Description
capsules, 0 (placebo), 100, 200, and 300 mg BID for 12 weeks
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S Colin Neill
Organizational Affiliation
President and CFO, Pharmos
Official's Role
Study Chair
Facility Information:
Facility Name
Alliance Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
Clinical Research Associates
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Mobile Medical and Diagnostic Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Radiant Research, Phoenix Southwest
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Arkansas Gastroenterology
City
Sherwood
State/Province
Arkansas
ZIP/Postal Code
72120
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Discovery Clinical Research
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
Facility Name
Community Clinical Trials
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Advance Clinical Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92869
Country
United States
Facility Name
Northern California Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95831
Country
United States
Facility Name
Medical Associates Research Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Westlake Medical Research
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Lynn Institute of the Rockies
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Rx Clinical Trials
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Borland-Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Genesis Research International
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Well Pharma Medical Research, Corp.
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
The Clinical Research Center of Northwest Florida
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
ACCORD Clinical Research, LLC
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
Meridien Research
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Mount Vernon Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Perimeter Institute for Clinical Research, Inc. (PICR)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Rosemark Women Care Specialists
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Rockford Gastroenterology Associates
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61101
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Arkansas City
State/Province
Kansas
ZIP/Postal Code
67005
Country
United States
Facility Name
Heartland Research Associates
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Trover Health System
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Clinical Trials of America
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Maryland Digestive Disease Research, LLC
City
Laurel
State/Province
Maryland
ZIP/Postal Code
20707
Country
United States
Facility Name
Capital Gastroenterology Consultants, PA
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20901
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Gastrointestinal Associates
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Meridan Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Digestive Disease Specialists
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
New Mexico Clinical Research & Osteoporosis Center, Inc
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Long Island Clinical Research Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Long Island Gastrointestinal Research Group
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
The Weill Medical College Of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Asheville Gastroenterology Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Cumberland Research Associates, LLC.
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Clinical Trials of America, Inc.
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Clinical Trials of America
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Medical Frontiers, LLC
City
Carlisle
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Digestive Health Network
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Gastroenterology Research Consultants of Greater Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Rapid Medical Research, Inc.
City
Cleveland,
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Gastrointestinal & Liver Diseases Consultants, PC
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45440
Country
United States
Facility Name
Toledo Center for Clinical Research
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Family Practice Center of Wadsworth, Inc.
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
Facility Name
Lynn Institute of Norman
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Aquilo Research
City
Yukon
State/Province
Oklahoma
ZIP/Postal Code
73099
Country
United States
Facility Name
TriValley Primary Care-Pennridge
City
Perkasie
State/Province
Pennsylvania
ZIP/Postal Code
18944
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mt Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
TriCities Medical Research
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
ClinSearch
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Memphis Gastroenterology Group
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Gastroenterology Associates
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Austin Gastroenterology, PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Radiant Research of Dallas-North
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Quality Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Gastroenterology Clinic of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Gastroenterology Associates of Tidewater
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Professional Place Medical Group, LLC
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
New River Valley Research Institute
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
National Clinical Recruiters, Inc
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Wenatchee Valley Medical Center
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of 3 Doses of Dextofisopam in Females With Irritable Bowel Syndrome
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