E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this study is to evaluate the safety and efficacy of AST-120 in the treatment of non-constipating IBS. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint of this study is the percent of patients who achieve at least 50% reduction in the number of days with abdominal pain during the final two weeks of the double-blind treatment course.
The primary safety endpoint is adverse events (AEs) deemed possibly, probably, or definitely related to treatment with investigational product during the double-blind treatment course. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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A patient is defined as having completed the study if they have received investigational product and are followed for safety through the last on-site visit (Week 18). Patients who withdraw from the study prior to Week 8 will be included in the analysis of the primary efficacy endpoint in the ITT analysis. Data collected for patients receiving the single blind treatment will be evaluated for safety in a separate analysis. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |