Irritable Bowel SyndromePhase 2NCT00454688
Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome
A Phase 2 study testing Asimadoline in people with Irritable Bowel Syndrome, run by Tioga Pharmaceuticals at 112 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of different doses of asimadoline in the treatment of patients with irritable bowel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Asimadoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 596 participants
- Where
- 112 sitesUnited States
- Study dates
- Aug 2006to Dec 2007
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18-79
- Must sign an ICF
- Females of childbearing potential must have a negative pregnancy test at screening and must adhere to contraception throughout the trial
- Must have been diagnosed with IBS as a result of having at least 6 months, not necessarily consecutive, in the preceding 12 months of recurrent symptoms of abdominal discomfort or pain associated with at least 2 of the following: 1)relieved with defecation; 2)onset associated with a change in stool frequency; 3)onset associated with a change in stool form
- Must demonstrate a willingness to comply with daily telephone diary entry
Who cannot join
- Any subject with evidence of a biochemical or structural abnormality of the digestive tract or other co-morbid illness that might impact the ability to interpret the safety and efficacy data
- Pregnant or breastfeeding females
- Refusal to discontinue prohibited concomitant medications
- Use of an investigational drug or participation in an investigational study within 30 days of screening
- Inability or unwillingness to use the touch-tone telephone data entry system
Trial locations and contacts
112 sites in 1 country.
112 sites in 1 country
United States112 sites
Akron Gastroenterology Assoc, Inc.
Akron, Ohio, 44302
New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico, 87106
Digestive Disorders Associate
Annapolis, Maryland, 21401
Northwest Gastroenterologists S.C.
Arlington Heights, Illinois, 60005
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, 28801
Covance CRU-Austin
Austin, Texas, 78752
Woodholme Gastroenterology Associates, PA
Baltimore, Maryland, 21208
Digestive Diseases Associates, PA
Baltimore, Maryland, 21229
Digestive Health Center of Louisianna
Baton Rouge, Louisiana, 70809
Montana Health Research Institute
Billings, Montana, 59102
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Meridian Research
Brooksville, Florida, 34613
Cary Medical Research Associates
Cary, North Carolina, 27511
UNC Chapel Hill
Chapel Hill, North Carolina, 27599
Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina, 28207
Metrolina Medical Research
Charlotte, North Carolina, 28209
Charlottesville Medical Research
Charlottesville, Virginia, 22911
Ridgeview Research
Chaska, Minnesota, 55318
ClinSearch
Chattanooga, Tennessee, 37404
Chevy Chase Clinical Research MGG
Chevy Chase, Maryland, 20815
Illinois Center for Clinical Research
Chicago, Illinois, 60622
New River Valley Research Institute
Christiansburg, Virginia, 24073
Digestive Health Network
Cincinnati, Ohio, 45220
Radiant Research
Cincinnati, Ohio, 45249
Alpha Clinical Research,LLC
Clarksville, Tennessee, 37043
Heartland Medical Research, Inc
Clive, Iowa, 50325
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80909
Radiant Research
Columbus, Ohio, 43212
Sadler Clinic
Conroe, Texas, 77304
Safe Harbor Clinical Research
East Providence, Rhode Island, 02917
Texas Tech University Health Sciences Center
El Paso, Texas, 79905
Sutter Institute for Medical Research
Elk Grove, California, 95758
Cumberland Research Associates
Fayetteville, North Carolina, 28304
Florida Medical Research Institute
Gainesville, Florida, 32607
Digestive & Liver Disease Specialists
Garden Grove, California, 92840
Memphis Gastroenterology Group
Germantown, Tennessee, 38138
Long Island Clinical Research Associates
Great Neck, New York, 11021
LeBauer research Associates, PA
Greensboro, North Carolina, 27403
Research Consultants Group
Hialeah, Florida, 33010
Unifour Medical Research Associates
Hickory, North Carolina, 28601
Discovery Alliance
Houston, Texas, 77004
NationsMed Clinical Research
Houston, Texas, 77036
Clinical Trials Network
Houston, Texas, 77074
Medical Affiliated Research Center
Huntsville, Alabama, 35801
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237
Irvine Center for Clinical Research Inc.
Irvine, California, 92618
Gastrointestinal Associates, PA
Jackson, Mississippi, 39202
Wells Institute for Health Awareness
Kettering, Ohio, 45429
Gastroenterology Associates
Kingsport, Tennessee, 37660
Gastroenterology Specialties, PC
Lincoln, Nebraska, 68503
Longmont Medical Research Network
Longmont, Colorado, 80501
University of Louisville GI Research
Louisville, Kentucky, 40202
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, 42431
Michael S. Levine, MD
Marietta, Georgia, 30067
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215
Radiant Research - Akron
Mogadore, Ohio, 44260
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Palmetto Medical Research
Mt. Pleasant, South Carolina, 29464
Dial Research Associates, Inc
Nashville, Tennessee, 37205
Suncoast Clinical Research
New Port Richey, Florida, 34652
Cornell Weill Medical College
New York, New York, 10021
Lion Research
Norman, Oklahoma, 73701
Northeast Medical Research Associates
North Dartmouth, Massachusetts, 02747
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117
University Digestive Health Center
Oak Forest, Illinois, 60452
Advanced Research Institute
Ogden, Utah, 84405
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654
Dr. Meera Dewan, PC
Omaha, Nebraska, 68144
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Community Clinical Trials
Orange, California, 92868
Universal Clinical Research & Technology
Orlando, Florida, 32833
Penninsula Research, Inc
Ormond Beach, Florida, 32174
Lovelace Scientific Resources
Pheonix, Arizona, 85016
Lovelace Scientific Resources
Phoenix, Arizona, 85016
Redpoint Research
Phoenix, Arizona, 85029
Radiant Research - St. Petersburg
Pinellas Park, Florida, 33781
Allegheny Center for Digestive Health
Pittsburgh, Pennsylvania, 15212
NW Gastroenterology Clinic
Portland, Oregon, 97210
West Hills Gastroenterology Associates, PC
Portland, Oregon, 97225
Triangle Medical Research Associates
Raleigh, North Carolina, 27609
Clinical Associates Research
Reisterstown, Maryland, 21136
National Clinical Research Inc
Richmond, Virginia, 23294
BHS Digestive Disease Associates
Riverside, Illinois, 60546
Rockford Gastroenterology Associates Ltd
Rockford, Illinois, 61107
Sutter Institute for Medical Research
Sacramento, California, 95816
Nothern California Research
Sacramento, California, 95831
Crescent Medical Research
Salisbury, North Carolina, 28144
J. Lewis Research Inc., Foothills Family Clinic
Salt Lake City, Utah, 84109
Sun Research Institute
San Antonio, Texas, 78205
Mount Vernon Clinical Research
Sandy Springs, Georgia, 30318
Lovelace Scientific Resources
Sarasota, Florida, 34233
Guthrie Clinical Research
Sayre, Pennsylvania, 18840
Mayo Clinic Scottsdale - Division of Gastroenterology
Scottsdale, Arizona, 85259
Hillcrest Clinical Research
Simpsonville, South Carolina, 29681
St. Louis Center for Clinical Research
St Louis, Missouri, 63128
Meridien Research
St. Petersburg, Florida, 33709
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Clinical Research Consultants, LLC
Stratford, Connecticut, 06615
Meridien Research
Tampa, Florida, 33606
Genova Clinical Research
Tucson, Arizona, 85741
Options Health Research, LLC
Tulsa, Oklahoma, 74104
Castlerock Clinical Research Consultants, LLC
Tulsa, Oklahoma, 74136
Phoenix Internal Medicine Associates, LLC
Waterbury, Connecticut, 06708
Westlake Medical Research
Westlake Village, California, 91361
Western States Clinical Research Inc
Wheat Ridge, Colorado, 80033
Professional Research Network of Kansas
Wichita, Kansas, 67203
Heartland Research Associates, LLC
Wichita, Kansas, 67207
Hanover Medical Specialists, PA
Wilmington, North Carolina, 28401
New Hannover Medical Research
Wilmington, North Carolina, 28412
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103
About this study
Official title: A 12-Week, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study of Asimadoline in Subjects With Irritable Bowel Syndrome
The purpose of this study is to evaluate the safety and efficacy of different doses of asimadoline in the treatment of patients with irritable bowel syndrome.
Read the detailed description
A randomized, dose-ranging, double-blind, placebo-controlled study designed to evaluate the efficacy and tolerability of three dose levels of asimadoline in subjects with IBS.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Asimadoline, Placebo
- Keywords
- Irritable Bowel Syndrome, Asimadoline
- 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.
AsimadolineDrug
Also called EMD 61753, EMR 63320
Asimadoline was provided in coated tablets of three dosages (0.15 mg, 0.5 mg, and 1.0 mg). All asimadoline tablets used in this trial were synthesized from the same batch of drug substance (Batch EF418492). Asimadoline was administered orally, BID for 12 weeks
PlaceboDrug
Placebo was provided in coated tablets identical in appearance to asimadoline tablets.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Asimadoline 0.15 mg | Experimental | Not described Receives: Drug: Asimadoline |
| Asimadoline 0.5 mg | Experimental | Not described Receives: Drug: Asimadoline |
| Asimadoline 1.0 mg | Experimental | Not described Receives: Drug: Asimadoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of IBS Pain - total months
The primary efficacy endpoint of the study was the total number of months with adequate relief of IBS pain or discomfort.
Measured: 12 weeks
Secondary outcomes (5)
Relief of IBS Pain - percent of patients
Proportion of subjects with adequate relief of IBS pain or discomfort
Measured: 12 weeks
Relief of IBS Symptoms
Adequate relief of IBS symptoms
Measured: 12 weeks
Lower GI function - change from baseline
Change from baseline in assessments of lower gastrointestinal (GI) function (i.e., stool frequency, stool consistency, urgency, bloating, and straining)
Measured: 12 weeks
Abdominal Pain Score - change from baseline
Change from baseline in abdominal pain score
Measured: 12 weeks
Abdominal Discomfort Score - change from baseline
Change from baseline in abdominal discomfort score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2007 (estimated)
- Study startAug 2006
- Primary completionNov 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tioga Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RTI Health Solutions
- Responsible party
- Sponsor
- Investigators
- Allen Mangel, MD, PhD, Study chair, Tioga Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454688
- Sponsor's protocol ID
- ASMP2003
- Status last verified
- Oct 2011
- First submitted
- 29 Mar 2007
- Last updated
- 18 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study of Asimadoline in Subjects With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00454688
- Acronym / sponsor ID
- ASMP2003
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Asimadoline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- Tioga PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- RTI Health Solutions
- Study start
- Aug 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 2 Apr 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 purpose of this study is to evaluate the safety and efficacy of different doses of asimadoline in the treatment of patients with irritable bowel syndrome.
Detailed description
A randomized, dose-ranging, double-blind, placebo-controlled study designed to evaluate the efficacy and tolerability of three dose levels of asimadoline in subjects with IBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Asimadoline 0.15 mg | Experimental | Drug: Asimadoline |
| Asimadoline 0.5 mg | Experimental | Drug: Asimadoline |
| Asimadoline 1.0 mg | Experimental | Drug: Asimadoline |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females aged 18-79
- Must sign an ICF
- Females of childbearing potential must have a negative pregnancy test at screening and must adhere to contraception throughout the trial
- Must have been diagnosed with IBS as a result of having at least 6 months, not necessarily consecutive, in the preceding 12 months of recurrent symptoms of abdominal discomfort or pain associated with at least 2 of the following: 1)relieved with defecation; 2)onset associated with a change in stool frequency; 3)onset associated with a change in stool form
- Must demonstrate a willingness to comply with daily telephone diary entry
Key exclusion criteria (5 listed)
- Any subject with evidence of a biochemical or structural abnormality of the digestive tract or other co-morbid illness that might impact the ability to interpret the safety and efficacy data
- Pregnant or breastfeeding females
- Refusal to discontinue prohibited concomitant medications
- Use of an investigational drug or participation in an investigational study within 30 days of screening
- Inability or unwillingness to use the touch-tone telephone data entry system
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 |
|---|---|---|
| AsimadolineAlso: EMD 61753, EMR 63320Asimadoline was provided in coated tablets of three dosages (0.15 mg, 0.5 mg, and 1.0 mg). All asimadoline tablets used in this trial were synthesized from the same batch of drug substance (Batch EF418492). Asimadoline was administered orally, BID for 12 weeks | Drug | Asimadoline 0.15 mg, Asimadoline 0.5 mg, Asimadoline 1.0 mg |
| PlaceboPlacebo was provided in coated tablets identical in appearance to asimadoline tablets. | Drug | Placebo |
Primary outcome
Relief of IBS Pain - total months
Time frame: 12 weeks
The primary efficacy endpoint of the study was the total number of months with adequate relief of IBS pain or discomfort.
5 secondary outcomes
Relief of IBS Pain - percent of patients
Time frame: 12 weeks
Relief of IBS Symptoms
Time frame: 12 weeks
Lower GI function - change from baseline
Time frame: 12 weeks
Abdominal Pain Score - change from baseline
Time frame: 12 weeks
Abdominal Discomfort Score - change from baseline
Time frame: 12 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 Oct 2011.
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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.
Allen Mangel, MD, PhD study chair
Tioga Pharmaceuticals
112 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Asimadoline in people with Irritable Bowel Syndrome, run by Tioga Pharmaceuticals at 112 sites in United States.
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 5 inclusion and 5 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 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 112 sites in United States. 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?
Relief of IBS Pain - total months (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2011.