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| ID | Type | Description | Link |
|---|---|---|---|
| LX1031.201 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose | Experimental | A high dose of LX1031; daily oral intake for 28 days |
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| Low Dose | Experimental | A low dose of LX1031; daily oral intake for 28 days |
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| Placebo | Placebo Comparator | Matching placebo dosing with daily oral intake |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LX1031 High Dose | Drug | A high dose of LX1031; daily oral intake for 28 days |
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| Measure | Description | Time Frame |
|---|---|---|
| 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?" | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel P. Freiman, MD | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genova Clinical Research | Tucson | Arizona | 85741 | United States | ||
| Arkansas Gastroenterology |
There was a 14-day Run-in period before randomization.
This was a multi-center trial in the United States, with 36 investigators participating.
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose | A high dose of LX1031; daily oral intake for 28 days |
| FG001 | Low Dose | A low dose of LX1031; daily oral intake for 28 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| LX1031 Low Dose |
| Drug |
A low dose of LX1031; daily oral intake for 28 days. |
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| Placebo | Drug | Matching placebo dosing with daily oral intake |
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| 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. | 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. | 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. | 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. | Baseline to Week 4 |
| Sherwood |
| Arkansas |
| 72120 |
| United States |
| Advanced Clinical Research Institute | Anaheim | California | 92801 | United States |
| Edinger Medical Group Clinical Research Center | Fountain Valley | California | 92708 | United States |
| Impact Clinical Trials | Los Angeles | California | 90036 | United States |
| Community Clinical Trials | Orange | California | 92868 | United States |
| AGMG - Orange | Orange | California | 92869 | United States |
| Medical Associates Research Group | San Diego | California | 92123 | United States |
| Lynn Instiute of the Rockies | Colorado Springs | Colorado | 80909 | United States |
| Clinical Trials Management of Boca Raton, Inc. | Boca Raton | Florida | 33486 | United States |
| Consultants for Clinical Research of S. Florida | Boynton Beach | Florida | 33426 | United States |
| Research Consultants Group | Hialeah | Florida | 33010 | United States |
| Accord Clinical Research, LLC | Port Orange | Florida | 32129 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| Northwest Clinical Trials | Boise | Idaho | 83704 | United States |
| ActivMed Practice and Research | Haverhill | Massachusetts | 01830 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Affiliated Clinical Research | Las Vegas | Nevada | 89128 | United States |
| Long Island Clinical Research | Great Neck | New York | 11021 | United States |
| Cary Medical Research | Cary | North Carolina | 27518 | United States |
| The UNC Center for Functional GI & Motility Disorders | Chapel Hill | North Carolina | 27599 | United States |
| Medoff Medical/Vital re:Search | Greensboro | North Carolina | 27108 | United States |
| Unifour Medical Research | Hickory | North Carolina | 28601 | United States |
| Piedmont Medical Associates | Winston-Salem | North Carolina | 27103 | United States |
| Consultants for Clinical Research | Cincinnati | Ohio | 45219 | United States |
| Gastroenterology Research Consultant of Greater Cincinnati | Cincinnati | Ohio | 45242 | United States |
| Oklahoma Foundation for Digestive Research | Oklahoma City | Oklahoma | 73104 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Coastal Carolina Research Center in Goose Creek | Goose Creek | South Carolina | 29455 | United States |
| ClinSearch | Chattanooga | Tennessee | 37404 | United States |
| Pioneer Research Solutions | Houston | Texas | 77036 | United States |
| Houston Medical Research Associates | Houston | Texas | 77090 | United States |
| Advanced Research Institute | Ogden | Utah | 84405 | United States |
| Utah Clinical Trials, LLC | Salt Lake City | Utah | 84107 | United States |
| National Clinical Research Norfolk Inc. | Norfolk | Virginia | 23502 | United States |
| Aurora Health Center - Waukesha | Waukesha | Wisconsin | 53186 | United States |
| FG002 | Placebo | Matching placebo dosing with daily oral intake |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose | A high dose of LX1031; daily oral intake for 28 days |
| BG001 | Low Dose | A low dose of LX1031; daily oral intake for 28 days |
| BG002 | Placebo | Matching placebo dosing with daily oral intake |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Measure based upon the per protocol population | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Measure based upon the per protocol population. | Number | participants |
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| Region of Enrollment | Number | participants |
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| IB Sub-type | Measure based upon the per protocol population. Non-constipating IBS patients entering the trial were classified into 2 groups: irritable bowel syndrome-diarrhea (IBS-D) or irritable bowel syndrome-mixed (IBS-M). | Number | participant |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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?" | Per protocol population; Last observation carried forward. | Posted | Number | Participants | Week 4 |
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| Secondary | 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. | Per protocol population; Last observation carried forward. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Week 4 |
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| Secondary | 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. | Per protocol population; Last observation carried forward. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Week 4 |
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| Secondary | 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. | Per protocol population; Last observation carried forward. | Posted | Mean | Standard Deviation | Number of daily stools | Baseline to Week 4 |
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| Secondary | 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. | Per protocol population; Last observation carried forward. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Week 4 |
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| Secondary | 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. | Per protocol population; Last observation carried forward. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Week 4 |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Dose | A high dose of LX1031; daily oral intake for 28 days | 1 | 49 | 11 | 49 | ||
| EG001 | Low Dose | A low dose of LX1031; daily oral intake for 28 days | 0 | 54 | 11 | 54 | ||
| EG002 | Placebo | Matching placebo dosing with daily oral intake | 0 | 52 | 13 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient ischemic attack | Nervous system disorders | MedRA 12.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedRA 12.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedRA 12.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedRA 12.0 | Systematic Assessment |
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| Abdominal Distension | Gastrointestinal disorders | MedRA 12.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedRA 12.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedRA 12.0 | Systematic Assessment |
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The sponsor requires that written permission be given before the PI can release any data publicly.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Lexicon Pharmaceuticals, Inc. | 281-863-3000 |
| 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 |
|---|---|
| C557875 | 2-amino-3-(4-(2-amino-6-(2,2,2-trifluoro-1-(3'-methoxybiphenyl-4-yl)ethoxy)-pyrimidin-4-yl)phenyl)propionic acid |
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| Male |
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| Black or African American |
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| Asian |
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| Other |
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| IBS-D |
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| Participants |
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| Participants |
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| Participants |
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