A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN PATIENTS WITH NON-CONSTIPATING IRRITABLE BOWEL SYNDROME

Conditions: Irritable bowel syndrome (IBS) is a chronic functional bowel disorder characterized by abdominal pain or discomfort and laterations in bowel habits. IBS is one of the most frequent conditions physicans are confronted with. The etiology of IBS remains unclear. It is likely caused by different factors in individuals such as colonic motor disturbances, visceral hypersensitivity, low grade intestinal inflammation, increased mucosal permeability and psychosocial disoders.

Registration Number: EUCTR2007-001950-18-BE

Lead Sponsor: Ocera Therapeutics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

18 to 80 years of age
Body Weight: (=40 kg)
Recurrent abdominal pain or discomfort for three or more days per month for the last three months which meets Rome III criteria for non-constipating IBS;
Patients on a stable diet for at least eight weeks;
Patients =50 years of age with a negative colonoscopy in the last five years;
Able and willing to comply with all protocol procedures for the planned duration of the study;
Able and willing to understand, sign and date an informed consent document, and authorise access to protected health information.
In addition, a female patient must meet the following criteria:
Females must be postmenopausal, surgically incapable of bearing children, or practicing a relaible method of birth control (intrauterine devices, spermicide and barrier) (Hormonal contraceptives are NOT regarded as adequate for the purposes of this trial). Partner/spouse sterility may also qualify at the Investigator's discretion. Females of child-bearing potential must also have a negative urine pregnancy test at baseline.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Constipating IBS
History of untreated lactose intolerance (NB: Patients treated with diet or lactase supplements are not excluded);
History of colonic or major abdominal surgery (colectomy, for example);
Current diagnosis of major depression or psychosis;
Known positive stool culture for Clostridium difficile or other pathogens;
Any condition necessitating the administration of analgesics (except Paracetamol), probiotics, neuroleptics, antidepressants, daytime tranquilizers, prokinetics or spasmolytics medications;
Active thyroid disease;
Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling;
Other major physical or major psychiatric illness within the last six months that in the opinion of the investigator would affect the patient's ability to complete the trial;
Uncontrolled systemic disease such as diabetes;
Patients undergoing chemotherapy for the treatment of cancer;
Known hypersensitivity or contraindication to any component of the test product (study drugs) or diagnostics used;
Participation in another study withing 8 weeks prior to the study
Unable to attend all visits required by the protocol