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

Condition(s) targeted: Irritable Bowel Syndrome

Intervention: dextofisopam (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Pharmos

Official(s) and/or principal investigator(s):
Alan Rubino, Study Chair, Affiliation: President and COO, Pharmos

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).

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 design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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).

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Female.

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.

Radiant Research, Phoenix Southwest, Chandler, Arizona 85225, United States; Recruiting
Tina Schaffner, Phone: 480-775-1115
Randall J Severance, MD, Principal Investigator

Arkansas Gastroenterology, Sherwood, Arkansas 72120, United States; Recruiting
Stephanie Hogue, Phone: 501-835-7100
Whitfield L Knapple, MD, Principal Investigator

Providence Clinical Research, Burbank, California 91505, United States; Recruiting
Margarita Ramos, Phone: 818-558-7555
Teresa S Sligh, MD, Principal Investigator

Community Clinical Trials, Orange, California 92868, United States; Recruiting
Amy Solis, Phone: 714-835-1870
David B Stanton, MD, Principal Investigator

Northern California Research, Sacramento, California 95831, United States; Recruiting
Kim Blanck, Phone: 916-392-3655
Douglas Young, MD, Principal Investigator

Medical Associates Research Group, San Diego, California 92123, United States; Recruiting
Dianne Tuohy, Phone: 858-277-5678
Michael T Bennett, MD, Principal Investigator

Advance Clinical Research Institute, Orange, California 92869, United States; Recruiting
Lupe Castro, Phone: 714-633-1824, Ext: 232
Steven L Duckor, MD, Principal Investigator

Washington Gastroenterology, PC, Washington DC, District of Columbia 20010, United States; Recruiting
Dawn Barth, Phone: 202-722-1171
Julio A Salcedo, MD, Principal Investigator

Genesis Research International, Longwood, Florida 32779, United States; Recruiting
Ruth E Flores, Phone: 407-331-9505, Ext: 3261
Raul E Tamayo, MD, Principal Investigator

Palm Beach Research Center, West Palm Beach, Florida 33409, United States; Recruiting
Novlett Lawrence, Phone: 561-689-0606
Isaac Marcadis, MD, Principal Investigator

Meridian Research, Brooksville, Florida 34613, United States; Recruiting
Lori Meurer, CCRC, Phone: 352-597-8839
Mildred V Farmer, MD, Principal Investigator

ACCORD Clinical Research, LLC, Port Orange, Florida 32129, United States; Recruiting
Shirley A Cowell, LPN, Phone: 386-760-7272
Donato R Ricci, MD, Principal Investigator

Borland-Groover Clinic, Jacksonville, Florida 32256, United States; Recruiting
Jackie Hazelip, Phone: 904-680-0871
Bradford W Joseph, MD, Principal Investigator

Emerald Coast Gastroenterology, Panama City, Florida 32405, United States; Recruiting
Barbara Davis, Phone: 850-215-2536
Mariusz J Klin, MD, PhD, Principal Investigator

Meridien Research, St. Petersburg, Florida 33709, United States; Recruiting
Angela Rivers, Phone: 727-347-8839
Gigi C Lefebvre, Principal Investigator

Mount Vernon Clinical Research, LLC, Sandy Springs, Georgia 30328, United States; Recruiting
Vicki Hopper, Phone: 404-843-4414
Gladstone A Sellers, MD, Principal Investigator

Heartland Research Associates, LLC, Arkansas City, Kansas 67005, United States; Recruiting
Jill Stangle, Phone: 620-442-1788
David A Schmeidler, MD, Principal Investigator

Heartland Research Associates, Wichita, Kansas 67207, United States; Recruiting
Amy Ludolph, Phone: 316-689-6684
Thomas C Klein, MD, Principal Investigator

Trover Health System, Madisonville, Kentucky 42431, United States; Recruiting
Robin Collard, Phone: 270-825-6643
Carroll M Steinfeld, MD, Principal Investigator

Maryland Digestive Disease Research, LLC, Laurel, Maryland 20707, United States; Recruiting
Meg Gordon, Phone: 240-554-0384
Christopher E Shih, MD, Principal Investigator

Capital Gastroenterology Consultants, PA, Silver Spring, Maryland 20901, United States; Recruiting
Mary Ellen Royalty, Phone: 301-681-3329
Milton J Koch, MD, Principal Investigator

New Mexico Clinical Research & Osteoporosis Center, Inc, Albuquerque, New Mexico 87106, United States; Recruiting
Sheri Romero, CCRC, Phone: 505-855-5505
Lance A Rudolph, MD, Principal Investigator

The Weill Medical College Of Cornell University, New York, New York 10021, United States; Not yet recruiting
Pam Davis, Phone: 646-962-5398
Christine L Frissora, MD, Principal Investigator

Long Island Gastrointestinal Research Group, Great Neck, New York 11023, United States; Recruiting
Tara Arnold, Phone: 516-482-5976
Michael J Goldstein, MD, Principal Investigator

Long Island Clinical Research Associates, Great Neck, New York 11021, United States; Recruiting
Michelle Grant, Phone: 516-466-1051
Blanche F Liu, MD, Principal Investigator

Winthrop University Hospital, Mineola, New York 11501, United States; Recruiting
Fayola Creft, Phone: 516-663-9582
Kavita K Kongara, MD, Principal Investigator

All-Trials Clinical Research, LLC, Winston-Salem, North Carolina 27103, United States; Recruiting
Cindy Jones, LPN, CRC, Phone: 336-659-1500, Ext: 104
Richard Lewis, MD, Principal Investigator

Asheville Gastroenterology Associates, Asheville, North Carolina 28801, United States; Recruiting
Jennifer Thompson, Phone: 828-350-3629, Ext: 446
William R Harlan, MD, Principal Investigator

Toledo Center for Clinical Research, Sylvania, Ohio 43560, United States; Recruiting
Melanie Schell, Phone: 419-885-5163
John A Winder, MD, Principal Investigator

Digestive Health Network, Cincinnati, Ohio 45220, United States; Recruiting
William Corbett, Phone: 513-961-2333
Robert M Kindel, MD, Principal Investigator

TriValley Primary Care-Pennridge, Perkasie, Pennsylvania 18944, United States; Recruiting
Nancy Feracco, Phone: 215-453-8877
David C Moll, MD, Principal Investigator

Coastal Carolina Research Center, Mt Pleasant, South Carolina 29464, United States; Recruiting
Janis Caldwell, Phone: 843-856-3784
Cynthia B Strout, MD, Principal Investigator

ClinSearch, Chattanooga, Tennessee 37404, United States; Recruiting
Tiffany Ball, Phone: 423-698-4584
Richard Krause, MD, Principal Investigator

TriCities Medical Research, Bristol, Tennessee 37620, United States; Recruiting
Tonya Ward-Kiser, Phone: 423-989-3105
David J Morin, MD, Principal Investigator

Research Across America, Dallas, Texas 75234, United States; Recruiting
Simona Marin, Phone: 972-241-1222
Joe Blumenau, MD, Principal Investigator

Radiant Research of Dallas-North, Dallas, Texas 75231, United States; Recruiting
Elizabeth White, Phone: 214-987-1616, Ext: 239
Michael D Reynolds, MD, Principal Investigator

Sun Research Institute, San Antonio, Texas 78205, United States; Recruiting
Yvonne Perez, Phone: 210-227-1289
Stephen C Cohen, MD, Principal Investigator

Austin Gastroenterology, PA, Austin, Texas 78745, United States; Recruiting
Linda Salas, Phone: 512-532-8032
Pradeep Kumar, MD, Principal Investigator

Quality Research, Inc., San Antonio, Texas 78209, United States; Recruiting
Jeane Harms, Phone: 608-541-8226
Curtis S Horn, MD, Principal Investigator

Advanced Research Institute, Ogden, Utah 84405, United States; Recruiting
Scott Lowe, Phone: 801-409-2040
John E Lowe, MD, Principal Investigator

National Clinical Recruiters, Inc, Richmond, Virginia 23294, United States; Recruiting
Lynn Bohannon, Phone: 804-672-2133, Ext: 29
John A Hoekstra, MD, Principal Investigator

Professional Place Medical Group, LLC, Chesapeake, Virginia 23320, United States; Recruiting
Lois Bosken, Phone: 757-481-9406
Richard A Craven, MD, Principal Investigator

Gastroenterology Associates of Tidewater, Chesapeake, Virginia 23320, United States; Recruiting
Crystal Beaber, Phone: 757-547-0798, Ext: 131
Pramod Malik, MD, Principal Investigator

Starting date: June 2007
Ending date: November 2008
Last updated: September 19, 2007