Irritable Bowel SyndromePhase 2NCT00813098

Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome

A Phase 2 study testing LX1031 High Dose and LX1031 Low Dose in people with Irritable Bowel Syndrome, run by Lexicon Pharmaceuticals at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX1031 versus a placebo control in subjects with non-constipating irritable bowel syndrome. 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?: LX1031 High Dose and LX1031 Low Dose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 155 participants
Where: 36 sitesUnited States
Study dates: Dec 2008to Aug 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Males and females aged 18-70 years old
Documented diagnosis of IBS (IBS-diarrhea or IBS-mixed) based upon Rome III criteria
Abdominal pain/discomfort at least 2 days per week during the screening and run-in periods
Normal structural evaluation of the colon within 5 years prior to screening
Ability to provide written informed consent

Who cannot join

Inability to discontinue current drug therapy for IBS, except for bulking agents, through the duration of the study
Use of anticholinergic antidepressants, opioid pain medications, or any drugs that affect bowel motility
Lactose intolerance
Major psychological disorder
Significant nicotine or caffeine use (>10 cigarettes and/or six 8 ounce cups of coffee per day, respectively)

Trial locations and contacts

36 sites in 1 country.

City, postcode or hospital

36 sites in 1 country

United States36 sites

Advanced Clinical Research Institute
Anaheim, California, 92801
Clinical Trials Management of Boca Raton, Inc.
Boca Raton, Florida, 33486
Northwest Clinical Trials
Boise, Idaho, 83704
Consultants for Clinical Research of S. Florida
Boynton Beach, Florida, 33426
Cary Medical Research
Cary, North Carolina, 27518
The UNC Center for Functional GI & Motility Disorders
Chapel Hill, North Carolina, 27599
ClinSearch
Chattanooga, Tennessee, 37404
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Gastroenterology Research Consultant of Greater Cincinnati
Cincinnati, Ohio, 45242
Lynn Instiute of the Rockies
Colorado Springs, Colorado, 80909
Edinger Medical Group Clinical Research Center
Fountain Valley, California, 92708
Coastal Carolina Research Center in Goose Creek
Goose Creek, South Carolina, 29455
Long Island Clinical Research
Great Neck, New York, 11021
Medoff Medical/Vital re:Search
Greensboro, North Carolina, 27108
ActivMed Practice and Research
Haverhill, Massachusetts, 01830
Research Consultants Group
Hialeah, Florida, 33010
Unifour Medical Research
Hickory, North Carolina, 28601
Pioneer Research Solutions
Houston, Texas, 77036
Houston Medical Research Associates
Houston, Texas, 77090
Affiliated Clinical Research
Las Vegas, Nevada, 89128
Impact Clinical Trials
Los Angeles, California, 90036
National Clinical Research Norfolk Inc.
Norfolk, Virginia, 23502
Advanced Research Institute
Ogden, Utah, 84405
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Community Clinical Trials
Orange, California, 92868
AGMG - Orange
Orange, California, 92869
Accord Clinical Research, LLC
Port Orange, Florida, 32129
Mayo Clinic
Rochester, Minnesota, 55905
Utah Clinical Trials, LLC
Salt Lake City, Utah, 84107
Medical Associates Research Group
San Diego, California, 92123
Arkansas Gastroenterology
Sherwood, Arkansas, 72120
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Genova Clinical Research
Tucson, Arizona, 85741
Aurora Health Center - Waukesha
Waukesha, Wisconsin, 53186
Piedmont Medical Associates
Winston-Salem, North Carolina, 27103

Other trials in United States

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 LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome

The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX1031 versus a placebo control in subjects with non-constipating irritable bowel syndrome.

Conditions: Irritable Bowel Syndrome
Being tested: LX1031 High Dose, LX1031 Low Dose, Placebo
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.

LX1031 High DoseDrug
A high dose of LX1031; daily oral intake for 28 days
LX1031 Low DoseDrug
A low dose of LX1031; daily oral intake for 28 days.
PlaceboDrug
Matching placebo dosing with daily oral intake

Study groups in NCT00813098
Study group	Role	What they receive
High dose	Experimental	A high dose of LX1031; daily oral intake for 28 days Receives: Drug: LX1031 High Dose
Low Dose	Experimental	A low dose of LX1031; daily oral intake for 28 days Receives: Drug: LX1031 Low Dose
Placebo	Placebo comparator	Matching placebo dosing with daily oral intake Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4
The primary efficacy endpoint was the proportion of subjects experiencing relief of IBS pain and discomfort at Week 4 as measured by the response to the question,"In the past 7 days have you had adequate relief of your irritable bowel syndrome pain and discomfort?"
Measured: Week 4

Secondary outcomes (5)

Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate
To assess sensation of urgency to defecate on a daily basis, subjects recorded in their daily diary a response to the following question,"Have you felt or experienced a sense of urgency to pass stool today?" The mean score (proportion of days per week when the subject experienced an urge to defecate) for Week 4 was subtracted from the baseline mean score to determine the mean change from baseline.
Measured: Baseline to Week 4
Change From Baseline at Week 4 in Stool Consistency Scores
Stool consistency was evaluated using the 7-point Bristol Stool Scale in which a score of 1 indicates separate hard lumps, 2 indicates sausage shaped but lumpy, 3 indicates sausage-like with cracks on the surface, 4 indicates sausage-like but smooth and soft, 5 indicates soft blobs with clear cut edges, 6 indicates fluffy pieces with ragged edges, and 7 indicates watery with no solid pieces. The mean score for Week 4 was subtracted from the baseline mean score to obtain the mean change from baseline.
Measured: Baseline to Week 4
Change From Baseline at Week 4 in Stool Frequency
Subjects recorded the number of times they passed stool on a daily basis in the daily diary. The mean for Week 4 was subtracted from the baseline mean to obtain the mean change from baseline in stool frequency.
Measured: Baseline to Week 4
Change From Baseline at Week 4 on the Severity of Bloating
Subjects recorded in the daily diary the level of bloating they felt on a daily basis using a 100 mm visual analog scale (with 0 being "not at all" and 100 mm being "worst possible"). The mean score for Week 4 was subtracted from the baseline mean score to obtain the mean change from baseline in severity of bloating.
Measured: Baseline to Week 4
Change From Baseline at Week 4 on the Global Improvement Score.
The IBS Global Improvement Scale (IBS-GAI) asks "Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been: 1-substantially worse, 2-moderately worse, 3-slightly worse, 4-no change, 5-slightly improved, 6-moderately improved, 7-substantially improved?" The mean score for Week 4 was subtracted from the mean baseline score to obtain the mean change from baseline on the Global Improvement Score.
Measured: Baseline to Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Aug 2010

First posted22 Dec 2008 (estimated)
Study startDec 2008
Primary completionJul 2009
Study completionAug 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 155 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00813098
Sponsor's protocol ID: Protocol LX1031.1-201-IBS
Other IDs: LX1031.201
Status last verified: Nov 2010
First submitted: 19 Dec 2008
Last updated: 2 Dec 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
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All Irritable Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2010. 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 LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome
ClinicalTrials.gov ID: NCT00813098
Acronym / sponsor ID: Protocol LX1031.1-201-IBS
Conditions: Irritable Bowel Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 155 participants (actual)
Lead sponsor: Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Jul 2009 (actual)
Study completion: Aug 2010 (actual)
First posted: 22 Dec 2008 (estimated)
Results: Posted 2 Dec 2010

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 the study is to evaluate the safety, tolerability, and effectiveness of LX1031 versus a placebo control in subjects with non-constipating irritable bowel syndrome.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
High dose	Experimental	Drug: LX1031 High DoseA high dose of LX1031; daily oral intake for 28 days
Low Dose	Experimental	Drug: LX1031 Low DoseA low dose of LX1031; daily oral intake for 28 days
Placebo	Placebo comparator	Drug: PlaceboMatching placebo dosing with daily oral intake

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Males and females aged 18-70 years old
Documented diagnosis of IBS (IBS-diarrhea or IBS-mixed) based upon Rome III criteria
Abdominal pain/discomfort at least 2 days per week during the screening and run-in periods
Normal structural evaluation of the colon within 5 years prior to screening
Ability to provide written informed consent

Key exclusion criteria (5 listed)

Inability to discontinue current drug therapy for IBS, except for bulking agents, through the duration of the study
Use of anticholinergic antidepressants, opioid pain medications, or any drugs that affect bowel motility
Lactose intolerance
Major psychological disorder
Significant nicotine or caffeine use (>10 cigarettes and/or six 8 ounce cups of coffee per day, respectively)

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
LX1031 High DoseA high dose of LX1031; daily oral intake for 28 days	Drug	High dose
LX1031 Low DoseA low dose of LX1031; daily oral intake for 28 days.	Drug	Low Dose
PlaceboMatching placebo dosing with daily oral intake	Drug	Placebo

Primary outcome

Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4
Time frame: Week 4
The primary efficacy endpoint was the proportion of subjects experiencing relief of IBS pain and discomfort at Week 4 as measured by the response to the question,"In the past 7 days have you had adequate relief of your irritable bowel syndrome pain and discomfort?"

5 secondary outcomes

Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate
Time frame: Baseline to Week 4
Change From Baseline at Week 4 in Stool Consistency Scores
Time frame: Baseline to Week 4
Change From Baseline at Week 4 in Stool Frequency
Time frame: Baseline to Week 4
Change From Baseline at Week 4 on the Severity of Bloating
Time frame: Baseline to Week 4
Change From Baseline at Week 4 on the Global Improvement Score.
Time frame: Baseline to Week 4

Results and safety

Results posted to the registry on 2 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Dose	49	46
Low Dose	54	46
Placebo	52	50

Primary outcome: Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4

Time frame: Week 4. Number. Unit: Participants

Measure	High Dose n = 43	Low Dose n = 44	Placebo n = 47
Value	23	18	20

Population analysed: Per protocol population; Last observation carried forward.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were followed at the start of study drug to no more than 14 days (30 days for serious adverse events) after the last dose of study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Dose	1 of 49 (2%)	11 of 49 (22.4%)	Not reported
Low Dose	0 of 54 (0%)	11 of 54 (20.4%)	Not reported
Placebo	0 of 52 (0%)	13 of 52 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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
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RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
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RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
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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.

Joel P. Freiman, MD study director

Lexicon Pharmaceuticals, Inc.

36 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 LX1031 High Dose and LX1031 Low Dose in people with Irritable Bowel Syndrome, run by Lexicon Pharmaceuticals at 36 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 2 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 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?

Yes. Results are posted in the registry (first posted 2 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4 (time frame: Week 4). 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 NCT00813098.

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 2 Dec 2010.