Irritable Bowel SyndromePhase 2NCT01494233
A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome
A Phase 2 study testing 250 mg LX1033 tablets in people with Irritable Bowel Syndrome, run by Lexicon Pharmaceuticals at 81 sites in United States.
Trial summary
The objective of this study is to evaluate the safety and efficacy of LX1033 over a range of dose levels in subjects with diarrhea-predominant Irritable Bowel Syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- 250 mg LX1033 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 373 participants
- Where
- 81 sitesUnited States
- Study dates
- Feb 2012to Sep 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects, aged 18 to 70 years, with diarrhea-predominant IBS (IBS-D) with symptom onset at least 6 months prior to diagnosis
- Two or more days per week with at least one stool with a consistency of Type 6 or 7 (Bristol Stool Form Scale)
- Weekly average of worst abdominal pain in past 24 hours score of greater than or equal to 3.0 using a 0-10 point scale
- Ability to provide written, informed consent
Who cannot join
- Inability to discontinue any current drug therapy for IBS, with the exception of bulking agents. Subjects will be allowed up to 2 doses of loperamide per week as rescue medication.
- Subjects who score severe abdominal pain (rated 7 or higher) 5 or more days per week
- Concomitant use of opioid analgesic drugs or drugs that affect bowel motility
- Any abnormalities or conditions deemed by the investigator as clinically significant
Trial locations and contacts
81 sites in 1 country.
81 sites in 1 country
United States81 sites
Lexicon Investigational Site
Addison, Illinois, 60101
Lexicon Investigational Site
Albuquerque, New Mexico, 87102
Lexicon Investigational Site
Anaheim, California, 92801
Lexicon Investigational Site
Austin, Texas, 78756
Lexicon Investigational Site
Berlin, New Jersey, 08009
Lexicon Investigational Site
Billings, Montana, 59102
Lexicon Investigational Site
Boise, Idaho, 83704
Lexicon Investigational Site
Boone, North Carolina, 28607
Lexicon Investigational Site
Bowling Green, Kentucky, 42101
Lexicon Investigational Site
Boynton Beach, Florida, 33426
Lexicon Investigational Site
Bradenton, Florida, 34208
Lexicon Investigational Site
Brockton, Massachusetts, 02301
Lexicon Investigational Site
Brooksville, Florida, 34601
Lexicon Investigational Site
Cary, North Carolina, 27518
Lexicon Investigational Site
Chapel Hill, North Carolina, 27599
Lexicon Investigational Site
Chattanooga, Tennessee, 37421
Lexicon Investigational Site
Chesterfield, Michigan, 48047
Lexicon Investigational Site
Chevy Chase, Maryland, 20815
Lexicon Investigational Site
Chicago, Illinois, 60622
Lexicon Investigational Site
Clinton, Utah, 84105
Lexicon Investigational Site
DeLand, Florida, 32720
Lexicon Investigational Site
El Paso, Texas, 79902
Lexicon Investigational Site
Encinitas, California, 92024
Lexicon Investigational Site
Eugene, Oregon, 97404
Lexicon Investigational Site
Fargo, North Dakota, 58103
Lexicon Investigational Site
Great Neck, New York, 11021
Lexicon Investigational Site
Great Neck, New York, 11023
Lexicon Investigational Site
Greensboro, North Carolina, 27408
Lexicon Investigational Site
High Point, North Carolina, 27262
Lexicon Investigational Site
Huntsville, Alabama, 35801
Lexicon Investigational Site
Jackson, Mississippi, 39202
Lexicon Investigational Site
Jacksonville, Florida, 32256
Lexicon Investigational Site
Kalamazoo, Michigan, 49009
Lexicon Investigational Site
Kettering, Ohio, 45429
Lexicon Investigational Site
Kissimmee, Florida, 34741
Lexicon Investigational Site
Lake Jackson, Texas, 77566
Lexicon Investigational Site
Lauderdale Lakes, Florida, 33319
Lexicon Investigational Site
Lexington, Kentucky, 40504
Lexicon Investigational Site
Lima, Ohio, 45806
Lexicon Investigational Site
Little Rock, Arkansas, 72211
Lexicon Investigational Site
Littleton, Colorado, 80120
Lexicon Investigational Site
Littleton, Colorado, 80128
Lexicon Investigational Site
Logan, Utah, 84341
Lexicon Investigational Site
Los Angeles, California, 90095
Lexicon Investigational Site
Lynchburg, Virginia, 24502
Lexicon Investigational Site
Maitland, Florida, 32751
Lexicon Investigational Site
Mentor, Ohio, 44060
Lexicon Investigational Site
Meridian, Idaho, 83642
Lexicon Investigational Site
Mexico, Missouri, 65265
Lexicon Investigational Site
Mt. Pleasant, South Carolina, 29464
Lexicon Investigational Site
New York, New York, 10022
Lexicon Investigational Site
Norman, Oklahoma, 73069
Lexicon Investigational Site
North Little Rock, Arkansas, 72117
Lexicon Investigational Site
Oakland, California, 94609
Lexicon Investigational Site
Ogden, Utah, 84405
Lexicon Investigational Site
Oklahoma City, Oklahoma, 73104
Lexicon Investigational Site
Orange, California, 92868
Lexicon Investigational Site
Orlando, Florida, 32806
Lexicon Investigational Site
Plano, Texas, 75075
Lexicon Investigational Site
Port Orange, Florida, 32129
Lexicon Investigational Site
Raleigh, North Carolina, 27612
Lexicon Investigational Site
Rockford, Illinois, 61107
Lexicon Investigational Site
San Antonio, Texas, 78229
Lexicon Investigational Site
San Diego, California, 92108
Lexicon Investigational Site
Sandy City, Utah, 84904
Lexicon Investigational Site
Santa Monica, California, 90404
Lexicon Investigational Site
Tampa, Florida, 33606
Lexicon Investigational Site
Tempe, Arizona, 85282
Lexicon Investigational Site
Towson, Maryland, 21204
Lexicon Investigational Site
Troy, Michigan, 48098
Lexicon Investigational Site
Tucson, Arizona, 85704
Lexicon Investigational Site
Tucson, Arizona, 85712
Lexicon Investigational Site
Tustin, California, 92780
Lexicon Investigational Site
Virginia Beach, Virginia, 23454
Lexicon Investigational Site
Wadsworth, Ohio, 44281
Lexicon Investigational Site
Waterbury, Connecticut, 06708
Lexicon Investigational Site
West Jordan, Utah, 84088
Lexicon Investigational Site
Westlake Village, California, 91361
Lexicon Investigational Site
Wheat Ridge, Colorado, 80033
Lexicon Investigational Site
Wichita, Kansas, 67207
Lexicon Investigational Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
The objective of this study is to evaluate the safety and efficacy of LX1033 over a range of dose levels in subjects with diarrhea-predominant Irritable Bowel Syndrome (IBS).
- Conditions
- Irritable Bowel Syndrome
- Being tested
- 250 mg LX1033 tablets, Placebo tablet
- 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.
250 mg LX1033 tabletsDrug
250 mg LX1033 tablets administered orally
Placebo tabletDrug
Matching placebo tablet administered orally
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | 500 mg LX1033 two times daily Receives: Drug: 250 mg LX1033 tablets |
| Mid dose | Experimental | 500 mg LX1033 three times daily Receives: Drug: 250 mg LX1033 tablets |
| High dose | Experimental | 1000 mg LX1033 two times daily Receives: Drug: 250 mg LX1033 tablets |
| Placebo | Placebo comparator | Matching placebo dosing Receives: Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in stool consistency
Measured: 4 weeks
Secondary outcomes (2)
Change from baseline in plasma 5-HIAA levels
Measured: 4 weeks
Change from baseline in worst abdominal pain in past 24 hours
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startFeb 2012
- Primary completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sumen Wason, MD, Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494233
- Sponsor's protocol ID
- LX1033.1-201-IBS
- Other IDs
- LX1033.201
- Status last verified
- Mar 2015
- First submitted
- 13 Dec 2011
- Last updated
- 23 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Delgado-Herrera L, Lasch K, Zeiher B, Lembo AJ, Drossman DA, Banderas B, Rosa K, Lademacher C, Arbuckle R. Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study population. Ther Adv Gastroenterol. 2017 Sep;10(9):673-687. doi: 10.1177/1756283X17726018. Epub 2017 Aug 24.
PubMed 28932269
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
- ClinicalTrials.gov ID
- NCT01494233
- Acronym / sponsor ID
- LX1033.1-201-IBS
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Sep 2013 (actual)
- First posted
- 16 Dec 2011 (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 efficacy of LX1033 over a range of dose levels in subjects with diarrhea-predominant Irritable Bowel Syndrome (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 |
|---|---|---|
| Low dose | Experimental | Drug: 250 mg LX1033 tablets500 mg LX1033 two times daily |
| Mid dose | Experimental | Drug: 250 mg LX1033 tablets500 mg LX1033 three times daily |
| High dose | Experimental | Drug: 250 mg LX1033 tablets1000 mg LX1033 two times daily |
| Placebo | Placebo comparator | Drug: Placebo tabletMatching placebo dosing |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects, aged 18 to 70 years, with diarrhea-predominant IBS (IBS-D) with symptom onset at least 6 months prior to diagnosis
- Two or more days per week with at least one stool with a consistency of Type 6 or 7 (Bristol Stool Form Scale)
- Weekly average of worst abdominal pain in past 24 hours score of greater than or equal to 3.0 using a 0-10 point scale
- Ability to provide written, informed consent
Key exclusion criteria (4 listed)
- Inability to discontinue any current drug therapy for IBS, with the exception of bulking agents. Subjects will be allowed up to 2 doses of loperamide per week as rescue medication.
- Subjects who score severe abdominal pain (rated 7 or higher) 5 or more days per week
- Concomitant use of opioid analgesic drugs or drugs that affect bowel motility
- Any abnormalities or conditions deemed by the investigator as clinically significant
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 |
|---|---|---|
| 250 mg LX1033 tablets250 mg LX1033 tablets administered orally | Drug | High dose, Low dose, Mid dose |
| Placebo tabletMatching placebo tablet administered orally | Drug | Placebo |
Primary outcome
Change from baseline in stool consistency
Time frame: 4 weeks
2 secondary outcomes
Change from baseline in plasma 5-HIAA levels
Time frame: 4 weeks
Change from baseline in worst abdominal pain in past 24 hours
Time frame: 4 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 23 Mar 2015.
- Derived from this study: PubMed 28932269Delgado-Herrera L, Lasch K, Zeiher B, Lembo AJ, Drossman DA, Banderas B, Rosa K, Lademacher C, Arbuckle R. Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study population. Ther Adv Gastroenterol. 2017 Sep;10(9):673-687. doi: 10.1177/1756283X17726018. Epub 2017 Aug 24.
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
Sumen Wason, MD study director
Lexicon Pharmaceuticals, Inc.
81 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 250 mg LX1033 tablets in people with Irritable Bowel Syndrome, run by Lexicon Pharmaceuticals at 81 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 4 inclusion and 4 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 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 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?
Change from baseline in stool consistency (time frame: 4 weeks). 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 NCT01494233, which also lists 1 linked publication.
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 23 Mar 2015.