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The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with non-constipating IBS. The study will test whether or not patients receiving AST-120 experience at least a 50% reduction in the number of days with abdominal pain compared to placebo.
Patients experiencing non-constipating IBS will be randomized to one of two arms in the study: the experimental drug AST-120 or placebo. Patients will take 2g of AST-120 or placebo three times per day for eight weeks. After the 8 week course, patients will receive an additional 8 weeks single blind treatment, after a one week washout period.
The experimental drug AST-120 is composed of black, odorless spherical carbon particles in 2g sachets (aluminum foil pouches). The placebo consists of microcrystalline cellulose spheres, Celphere CP-305 stained to match the appearance of AST-120, in 2g sachets (aluminum foil pouches). Both AST-120 and placebo are oral (taken by mouth) preparations. Both are tasteless. To take the product, patients will tear open the sachet, drop the contents directly on their tongue and wash it down with 8 ounces of water.
Patients will be expected to participate in up to 10 visits, approximately three by telephone and the remainder of visits are in-clinic. At these visits, patients will undergo a number of tests including: hematology panel, lactose intolerance testing, physical exams, pregnancy tests, evaluations based on the following scales: The Bristol Stool Scale, IBS Severity Scale, IBS Quality of Life, SCL-90R.
Provided the patient has been stable for eight weeks prior to their baseline visit, they will be allowed to take the following medications: drugs that inhibit gastric secretion (histamine blockers, proton pump inhibitors), benzodiazepines and Imidazopyridines (short acting, nonbenzodiazepine hypnotics) for sleep (dose must be consistent with the use of a sleep agent) aspirin at a cardiovascular prophylactic dose (75-150 mg/day) and paracetamol. Antidepressants for non-IBS symptoms are allowed. Loperamide will be permitted as a rescue for diarrhea only when patients are experiencing at least 3 liquid or soft stools in one day. However, Loperamide is prohibited during the two week screening period.
Patients will not be allowed to take the following medications whilst on trial and these therapies must have been discontinued by at least two weeks prior to their baseline visit: probiotics, neuroleptics, antidepressants for IBS symptoms, daytime tranquilizers, prokinetics, spasmolytics, analgesics, other investigational agents and any over-the-counter medications.
Patient will be required to keep a diary during the study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AST-120, 2 gram sachets |
|
| 2 | Placebo Comparator | Celphere® CP-305, stained to match appearance of AST-120, in 2g sachets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AST-120 | Drug | oral, sachet, 2 grams three times daily for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients who achieve at least a 50% reduction in the number of days with abdominal pain during the final 2 weeks of the double-blind treatment course. | Eight weeks | |
| Safety endpoint is adverse events (AEs) deemed possibly, probably, or definitely related to treatment with investigational product during the double-blind treatment course. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in the IBS QOL score. | Eight weeks | |
| Percent change in HADS score. | 8 weeks | |
| Percent change in Bristol Scale score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Tack, MD | University of Leuven, Department of Gastroenterology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Associates | Huntsville | Alabama | 35801 | United States | ||
| Northern California Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16678553 | Background | Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. doi: 10.1053/j.gastro.2006.03.008. No abstract available. | |
| 11474909 | Background | Schuster MM. Defining and diagnosing irritable bowel syndrome. Am J Manag Care. 2001 Jul;7(8 Suppl):S246-51. |
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| Celphere® CP-305 |
| Drug |
oral, placebo, sachet, 2 grams three times daily for 8 weeks |
|
| 8 weeks |
| Percent change in individual items in the IBS Symptom Severity questionnaire. | 8 weeks |
| Durability of effect after the first eight weeks of treatment. | 8 weeks |
| Change in clinical laboratory tests from Baseline to Week 8 and to Week 18. | 8 weeks |
| Any adverse event occurring after Week 8. | 8 weeks |
| Physical examinations, vital signs (blood pressure, heart rate, respiration and temperature). | 8 weeks |
| Sacramento |
| California |
| 95821 |
| United States |
| Medical Center for Clinical Research | San Diego | California | 92108 | United States |
| Madeleine DuPree, MD | Boynton Beach | Florida | 33436 | United States |
| Michael Epstein, MD | Annapolis | Maryland | 21401 | United States |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | United States |
| Long Island Gastrointestinal Research Group | Great Neck | New York | 11023 | United States |
| LeBauer Research Associates | Greensboro | North Carolina | 27403 | United States |
| Peters Medical Research, LLC | High Point | North Carolina | 27262 | United States |
| Ohio Gastroenterology and Liver Institute | Cincinnatti | Ohio | 45219 | United States |
| Oklahoma Foundation for Digestive Disease | Oklahoma City | Oklahoma | 73104 | United States |
| Breco Research LTD | Houston | Texas | 77024 | United States |
| Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | 53215 | United States |
| Zuid-Oost Limburg Campus St. Jan | Genk | Genk | 3600 | Belgium |
| UCL St. Luc | Woluwe | Woluwe | 1200 | Belgium |
| AZ St. Lucas Assebroek | Assebroek | 8310 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| 16401691 | Background | Tack J, Broekaert D, Fischler B, Van Oudenhove L, Gevers AM, Janssens J. A controlled crossover study of the selective serotonin reuptake inhibitor citalopram in irritable bowel syndrome. Gut. 2006 Aug;55(8):1095-103. doi: 10.1136/gut.2005.077503. Epub 2006 Jan 9. |
| 16531524 | Background | Wood JD. Histamine, mast cells, and the enteric nervous system in the irritable bowel syndrome, enteritis, and food allergies. Gut. 2006 Apr;55(4):445-7. doi: 10.1136/gut.2005.079046. |
| 21883322 | Result | Tack JF, Miner PB Jr, Fischer L, Harris MS. Randomised clinical trial: the safety and efficacy of AST-120 in non-constipating irritable bowel syndrome - a double-blind, placebo-controlled study. Aliment Pharmacol Ther. 2011 Oct;34(8):868-77. doi: 10.1111/j.1365-2036.2011.04818.x. Epub 2011 Aug 24. |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C040896 | AST 120 |
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