Irritable Bowel SyndromePhase 2NCT00583128
Safety and Efficacy of AST-120 in Patients With Non-Constipating Irritable Bowel Syndrome
A Phase 2 study testing AST-120 and Celphere® CP-305 in people with Irritable Bowel Syndrome, run by Ocera Therapeutics at 17 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- AST-120 and Celphere® CP-305
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Aug 2007to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 screening 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 authorize access to protected health information,
- Females must be postmenopausal, surgically incapable of bearing children, or practicing a reliable method of birth control (intrauterine devices, spermicide and barrier) (Hormonal contraceptives are NOT regarded as adequate for the purpose of this trial.) Partner/spouse sterility may also qualify at the Investigator's discretion. Females of child-bearing potential must have a negative urine pregnancy test at baseline.
Who cannot join
- Constipating IBS;
- History of untreated lactose intolerance;
- History of colonic or major abdominal surgery (colectomy, for example);
- Active (untreated) Thyroid disease;
- Current diagnosis of major depression or psychosis;
- Known positive stool cultures for Clostridium difficile or other pathogens;
Show all 15Show fewer
- Any condition necessitating the administration of analgesics (except paracetamol), probiotics, neuroleptics, antidepressants for IBS symptoms, daytime tranquilizers, prokinetics or spasmolytic medications;
- 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 within eight (8) weeks prior to the study;
- Unable to attend all visits required by the protocol;
- Female patients must be excluded if they are pregnant, breast feeding, or planning to become pregnant during the study.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States13 sites
Michael Epstein, MD
Annapolis, Maryland, 21401
Madeleine DuPree, MD
Boynton Beach, Florida, 33436
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Ohio Gastroenterology and Liver Institute
Cincinnatti, Ohio, 45219
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023
LeBauer Research Associates
Greensboro, North Carolina, 27403
Peters Medical Research, LLC
High Point, North Carolina, 27262
Breco Research LTD
Houston, Texas, 77024
Clinical Research Associates
Huntsville, Alabama, 35801
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215
Oklahoma Foundation for Digestive Disease
Oklahoma City, Oklahoma, 73104
Northern California Research
Sacramento, California, 95821
Medical Center for Clinical Research
San Diego, California, 92108
Belgium4 sites
AZ St. Lucas Assebroek
Assebroek, 8310
Zuid-Oost Limburg Campus St. Jan
Genk, Genk, 3600
UZ Leuven
Leuven, 3000
UCL St. Luc
Woluwe, Woluwe, 1200
About this study
Official title: 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
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.
Read the detailed description
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
- Conditions
- Irritable Bowel Syndrome
- Being tested
- AST-120, Celphere® CP-305
- Keywords
- IBS, Irritable Bowel Syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AST-120Drug
oral, sachet, 2 grams three times daily for 8 weeks
Celphere® CP-305Drug
oral, placebo, sachet, 2 grams three times daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AST-120, 2 gram sachets Receives: Drug: AST-120 |
| 2 | Placebo comparator | Celphere® CP-305, stained to match appearance of AST-120, in 2g sachets Receives: Drug: Celphere® CP-305 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (8)
Percent change in the IBS QOL score.
Measured: Eight weeks
Percent change in HADS score.
Measured: 8 weeks
Percent change in Bristol Scale score.
Measured: 8 weeks
Percent change in individual items in the IBS Symptom Severity questionnaire.
Measured: 8 weeks
Durability of effect after the first eight weeks of treatment.
Measured: 8 weeks
Change in clinical laboratory tests from Baseline to Week 8 and to Week 18.
Measured: 8 weeks
Any adverse event occurring after Week 8.
Measured: 8 weeks
Physical examinations, vital signs (blood pressure, heart rate, respiration and temperature).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startAug 2007
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocera Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Tack, MD, Principal investigator, University of Leuven, Department of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583128
- Sponsor's protocol ID
- AST014
- Status last verified
- Jun 2014
- First submitted
- 20 Dec 2007
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16678553Schuster MM. Defining and diagnosing irritable bowel syndrome. Am J Manag Care. 2001 Jul;7(8 Suppl):S246-51.
PubMed 11474909Tack 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.
PubMed 16401691Wood 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.
PubMed 16531524Tack 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.
PubMed 21883322
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00583128
- Acronym / sponsor ID
- AST014
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, Irritable Bowel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Ocera TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 31 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AST-120AST-120, 2 gram sachets |
| 2 | Placebo comparator | Drug: Celphere® CP-305Celphere® CP-305, stained to match appearance of AST-120, in 2g sachets |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 screening colonoscopy in the last five years;
- Able and willing to comply with all protocol procedures for the planned duration of the study;
Key exclusion criteria (15 listed)
- Constipating IBS;
- History of untreated lactose intolerance;
- History of colonic or major abdominal surgery (colectomy, for example);
- Active (untreated) Thyroid disease;
- Current diagnosis of major depression or psychosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AST-120oral, sachet, 2 grams three times daily for 8 weeks | Drug | 1 |
| Celphere® CP-305oral, placebo, sachet, 2 grams three times daily for 8 weeks | Drug | 2 |
Primary outcome
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.
Time frame: 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.
Time frame: 8 weeks
8 secondary outcomes
Percent change in the IBS QOL score.
Time frame: Eight weeks
Percent change in HADS score.
Time frame: 8 weeks
Percent change in Bristol Scale score.
Time frame: 8 weeks
Percent change in individual items in the IBS Symptom Severity questionnaire.
Time frame: 8 weeks
Durability of effect after the first eight weeks of treatment.
Time frame: 8 weeks
Change in clinical laboratory tests from Baseline to Week 8 and to Week 18.
Time frame: 8 weeks
Any adverse event occurring after Week 8.
Time frame: 8 weeks
Physical examinations, vital signs (blood pressure, heart rate, respiration and temperature).
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
- Background: PubMed 16678553Drossman 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.
- Background: PubMed 11474909Schuster MM. Defining and diagnosing irritable bowel syndrome. Am J Manag Care. 2001 Jul;7(8 Suppl):S246-51.
- Background: PubMed 16401691Tack 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.
- Background: PubMed 16531524Wood 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.
- Results publication: PubMed 21883322Tack 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Tack, MD principal investigator
University of Leuven, Department of Gastroenterology
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AST-120 and Celphere® CP-305 in people with Irritable Bowel Syndrome, run by Ocera Therapeutics at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Eight weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00583128, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2014.