Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome
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| ClinicalTrials.gov Identifier: NCT00813098 |
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Recruitment Status :
Completed
First Posted : December 22, 2008
Results First Posted : December 2, 2010
Last Update Posted : December 2, 2010
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Sponsor:
Lexicon Pharmaceuticals
Information provided by:
Lexicon Pharmaceuticals
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Irritable Bowel Syndrome | Drug: LX1031 High Dose Drug: LX1031 Low Dose Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 155 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | December 2008 |
| Actual Primary Completion Date : | July 2009 |
| Actual Study Completion Date : | August 2010 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: High dose
A high dose of LX1031; daily oral intake for 28 days
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Drug: LX1031 High Dose
A high dose of LX1031; daily oral intake for 28 days |
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Experimental: Low Dose
A low dose of LX1031; daily oral intake for 28 days
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Drug: LX1031 Low Dose
A low dose of LX1031; daily oral intake for 28 days. |
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Placebo Comparator: Placebo
Matching placebo dosing with daily oral intake
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Drug: Placebo
Matching placebo dosing with daily oral intake |
Primary Outcome Measures :
- 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?"
Secondary Outcome Measures :
- Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate [ Time Frame: Baseline to Week 4 ]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.
- Change From Baseline at Week 4 in Stool Consistency Scores [ Time Frame: Baseline to Week 4 ]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.
- Change From Baseline at Week 4 in Stool Frequency [ Time Frame: Baseline to Week 4 ]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.
- Change From Baseline at Week 4 on the Severity of Bloating [ Time Frame: Baseline to Week 4 ]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.
- Change From Baseline at Week 4 on the Global Improvement Score. [ Time Frame: Baseline to Week 4 ]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.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813098
Locations
Show 36 study locations
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
| Study Director: | Joel P. Freiman, MD | Lexicon Pharmaceuticals, Inc. |
| Responsible Party: | Joel P. Freiman, MD, MPH / Medical Director Drug Safety, Lexicon Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00813098 |
| Other Study ID Numbers: |
Protocol LX1031.1-201-IBS LX1031.201 ( Other Identifier: Lexicon Pharmaceuticals, Inc. ) |
| First Posted: | December 22, 2008 Key Record Dates |
| Results First Posted: | December 2, 2010 |
| Last Update Posted: | December 2, 2010 |
| Last Verified: | November 2010 |
Additional relevant MeSH terms:
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Irritable Bowel Syndrome Syndrome Disease Pathologic Processes Colonic Diseases, Functional |
Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |