Irritable Bowel SyndromePhase 2NCT00486876
A Study of 3 Doses of Dextofisopam in Females With Irritable Bowel Syndrome
A Phase 2 study testing Dextofisopam in people with Irritable Bowel Syndrome, run by Pharmos at 79 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Dextofisopam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 79 sitesUnited States
- Study dates
- Jun 2007to Oct 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
79 sites in 1 country.
79 sites in 1 country
United States79 sites
New Mexico Clinical Research & Osteoporosis Center, Inc
Albuquerque, New Mexico, 87106
University of Michigan
Ann Arbor, Michigan, 48109
Heartland Research Associates, LLC
Arkansas City, Kansas, 67005
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801
Mount Vernon Clinical Research
Atlanta, Georgia, 30328
Perimeter Institute for Clinical Research, Inc. (PICR)
Atlanta, Georgia, 30338
Austin Gastroenterology, PA
Austin, Texas, 78745
Alliance Clinical Research
Birmingham, Alabama, 35215
TriCities Medical Research
Bristol, Tennessee, 37620
Meridien Research
Brooksville, Florida, 34613
Providence Clinical Research
Burbank, California, 91505
Medical Frontiers, LLC
Carlisle, Ohio, 45005
Radiant Research, Phoenix Southwest
Chandler, Arizona, 85225
ClinSearch
Chattanooga, Tennessee, 37421
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
Professional Place Medical Group, LLC
Chesapeake, Virginia, 23320
New River Valley Research Institute
Christiansburg, Virginia, 24073
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Digestive Health Network
Cincinnati, Ohio, 45220
Gastroenterology Research Consultants of Greater Cincinnati
Cincinnati, Ohio, 45242
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80909
Radiant Research of Dallas-North
Dallas, Texas, 75231
Research Across America
Dallas, Texas, 75234
Gastrointestinal & Liver Diseases Consultants, PC
Dayton, Ohio, 45440
Discovery Clinical Research
Encinitas, California, 92024
Cumberland Research Associates, LLC.
Fayetteville, North Carolina, 28304
Digestive and Liver Disease Specialists
Garden Grove, California, 92840
Memphis Gastroenterology Group
Germantown, Tennessee, 38138
Long Island Clinical Research Associates
Great Neck, New York, 11021
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023
Clinical Trials of America, Inc.
Hickory, North Carolina, 28601
Clinical Research Associates
Huntsville, Alabama, 35801
Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404
Gastrointestinal Associates
Jackson, Mississippi, 39202
Borland-Groover Clinic
Jacksonville, Florida, 32256
Gastroenterology Associates
Kingsport, Tennessee, 37660
Digestive Disease Specialists
Las Vegas, Nevada, 89128
Maryland Digestive Disease Research, LLC
Laurel, Maryland, 20707
Genesis Research International
Longwood, Florida, 32779
Trover Health System
Madisonville, Kentucky, 42431
Well Pharma Medical Research, Corp.
Miami, Florida, 33143
Winthrop University Hospital
Mineola, New York, 11501
Mobile Medical and Diagnostic Center
Mobile, Alabama, 36617
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
The Weill Medical College Of Cornell University
New York, New York, 10021
Lynn Institute of Norman
Norman, Oklahoma, 73069
Renstar Medical Research
Ocala, Florida, 34471
Advanced Research Institute
Ogden, Utah, 84405
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Meridan Clinical Research
Omaha, Nebraska, 68134
Community Clinical Trials
Orange, California, 92868
Advance Clinical Research Institute
Orange, California, 92869
Compass Research, LLC
Orlando, Florida, 32806
The Clinical Research Center of Northwest Florida
Panama City, Florida, 32405
TriValley Primary Care-Pennridge
Perkasie, Pennsylvania, 18944
ACCORD Clinical Research, LLC
Port Orange, Florida, 32129
National Clinical Recruiters, Inc
Richmond, Virginia, 23294
Rockford Gastroenterology Associates
Rockford, Illinois, 61101
Northern California Research
Sacramento, California, 95831
Sun Research Institute
San Antonio, Texas, 78205
Quality Research, Inc.
San Antonio, Texas, 78209
Gastroenterology Clinic of San Antonio
San Antonio, Texas, 78229
Medical Associates Research Group
San Diego, California, 92123
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Arkansas Gastroenterology
Sherwood, Arkansas, 72120
Clinical Trials of America
Shreveport, Louisiana, 71101
Capital Gastroenterology Consultants, PA
Silver Spring, Maryland, 20901
Meridien Research
St. Petersburg, Florida, 33709
Toledo Center for Clinical Research
Sylvania, Ohio, 43560
Family Practice Center of Wadsworth, Inc.
Wadsworth, Ohio, 44281
Rx Clinical Trials
Washington D.C., District of Columbia, 20010
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801
Palm Beach Research Center
West Palm Beach, Florida, 33409
Westlake Medical Research
Westlake Village, California, 91361
Heartland Research Associates
Wichita, Kansas, 67207
Clinical Trials of America
Winston-Salem, North Carolina, 27103
North Georgia Clinical Research
Woodstock, Georgia, 30189
Aquilo Research
Yukon, Oklahoma, 73099
About this study
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
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).
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Dextofisopam
- Keywords
- Irritable bowel syndrome, Diarrhea predominant Irritable Bowel Syndrome, Alternating Irritable Bowel Syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextofisopamDrug
capsules, 0 (placebo), 100, 200, and 300 mg BID for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: Dextofisopam |
| 2 | Experimental | 100 mg BID Receives: Drug: Dextofisopam |
| 3 | Experimental | 200 mg BID Receives: Drug: Dextofisopam |
| 4 | Experimental | 300 mg BID Receives: Drug: Dextofisopam |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of weeks for which patients record adequate overall relief of IBS symptoms during the double blind period (12 weeks of treatment).
Measured: June 07 thru August 09
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionSep 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmos
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- S Colin Neill, Study chair, President and CFO, Pharmos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486876
- Sponsor's protocol ID
- VPI-TOFP-203
- Status last verified
- Aug 2011
- First submitted
- 13 Jun 2007
- Last updated
- 2 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00486876
- Acronym / sponsor ID
- VPI-TOFP-203
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome, Diarrhea predominant Irritable Bowel Syndrome, Alternating Irritable Bowel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- PharmosIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 15 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: DextofisopamPlacebo |
| 2 | Experimental | Drug: Dextofisopam100 mg BID |
| 3 | Experimental | Drug: Dextofisopam200 mg BID |
| 4 | Experimental | Drug: Dextofisopam300 mg BID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextofisopamcapsules, 0 (placebo), 100, 200, and 300 mg BID for 12 weeks | Drug | 1, 2, 3, 4 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S Colin Neill study chair
President and CFO, Pharmos
79 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dextofisopam in people with Irritable Bowel Syndrome, run by Pharmos at 79 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2011.