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

This study has been completed.
Sponsor:
Information provided by:
Pharmos
ClinicalTrials.gov Identifier:
NCT00486876
First received: June 13, 2007
Last updated: August 1, 2011
Last verified: August 2011
  Purpose

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).


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: Dextofisopam
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pharmos:

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). [ Time Frame: June 07 thru August 09 ] [ Designated as safety issue: No ]

Enrollment: 324
Study Start Date: June 2007
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: Dextofisopam
capsules, 0 (placebo), 100, 200, and 300 mg BID for 12 weeks
Experimental: 2
100 mg BID
Drug: Dextofisopam
capsules, 0 (placebo), 100, 200, and 300 mg BID for 12 weeks
Experimental: 3
200 mg BID
Drug: Dextofisopam
capsules, 0 (placebo), 100, 200, and 300 mg BID for 12 weeks
Experimental: 4
300 mg BID
Drug: Dextofisopam
capsules, 0 (placebo), 100, 200, and 300 mg BID for 12 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486876

  Show 79 Study Locations
Sponsors and Collaborators
Pharmos
Investigators
Study Chair: S Colin Neill President and CFO, Pharmos
  More Information

No publications provided

Responsible Party: President, Pharmos Corporation
ClinicalTrials.gov Identifier: NCT00486876     History of Changes
Other Study ID Numbers: VPI-TOFP-203
Study First Received: June 13, 2007
Last Updated: August 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pharmos:
Irritable bowel syndrome
Diarrhea predominant Irritable Bowel Syndrome
Alternating Irritable Bowel Syndrome

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Tofisopam
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014