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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LX1031 High Dose
LX1031 Low Dose
Placebo
Sponsored by
Lexicon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Genova Clinical Research
  • Arkansas Gastroenterology
  • Advanced Clinical Research Institute
  • Edinger Medical Group Clinical Research Center
  • Impact Clinical Trials
  • Community Clinical Trials
  • AGMG - Orange
  • Medical Associates Research Group
  • Lynn Instiute of the Rockies
  • Clinical Trials Management of Boca Raton, Inc.
  • Consultants for Clinical Research of S. Florida
  • Research Consultants Group
  • Accord Clinical Research, LLC
  • Clinical Research Atlanta
  • Northwest Clinical Trials
  • ActivMed Practice and Research
  • Mayo Clinic
  • Affiliated Clinical Research
  • Long Island Clinical Research
  • Cary Medical Research
  • The UNC Center for Functional GI & Motility Disorders
  • Medoff Medical/Vital re:Search
  • Unifour Medical Research
  • Piedmont Medical Associates
  • Consultants for Clinical Research
  • Gastroenterology Research Consultant of Greater Cincinnati
  • Oklahoma Foundation for Digestive Research
  • Lynn Health Science Institute
  • Coastal Carolina Research Center in Goose Creek
  • ClinSearch
  • Pioneer Research Solutions
  • Houston Medical Research Associates
  • Advanced Research Institute
  • Utah Clinical Trials, LLC
  • National Clinical Research Norfolk Inc.
  • Aurora Health Center - Waukesha

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

High dose

Low Dose

Placebo

Arm Description

A high dose of LX1031; daily oral intake for 28 days

A low dose of LX1031; daily oral intake for 28 days

Matching placebo dosing with daily oral intake

Outcomes

Primary Outcome Measures

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?"

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
December 19, 2008
Last Updated
November 4, 2010
Sponsor
Lexicon Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00813098
Brief Title
Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome
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 Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lexicon Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High dose
Arm Type
Experimental
Arm Description
A high dose of LX1031; daily oral intake for 28 days
Arm Title
Low Dose
Arm Type
Experimental
Arm Description
A low dose of LX1031; daily oral intake for 28 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo dosing with daily oral intake
Intervention Type
Drug
Intervention Name(s)
LX1031 High Dose
Intervention Description
A high dose of LX1031; daily oral intake for 28 days
Intervention Type
Drug
Intervention Name(s)
LX1031 Low Dose
Intervention Description
A low dose of LX1031; daily oral intake for 28 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo dosing with daily oral intake
Primary Outcome Measure Information:
Title
Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4
Description
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?"
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate
Description
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.
Time Frame
Baseline to Week 4
Title
Change From Baseline at Week 4 in Stool Consistency Scores
Description
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.
Time Frame
Baseline to Week 4
Title
Change From Baseline at Week 4 in Stool Frequency
Description
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.
Time Frame
Baseline to Week 4
Title
Change From Baseline at Week 4 on the Severity of Bloating
Description
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.
Time Frame
Baseline to Week 4
Title
Change From Baseline at Week 4 on the Global Improvement Score.
Description
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.
Time Frame
Baseline to Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel P. Freiman, MD
Organizational Affiliation
Lexicon Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Genova Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Arkansas Gastroenterology
City
Sherwood
State/Province
Arkansas
ZIP/Postal Code
72120
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Edinger Medical Group Clinical Research Center
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Impact Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Community Clinical Trials
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
AGMG - Orange
City
Orange
State/Province
California
ZIP/Postal Code
92869
Country
United States
Facility Name
Medical Associates Research Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Lynn Instiute of the Rockies
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Clinical Trials Management of Boca Raton, Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Consultants for Clinical Research of S. Florida
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Research Consultants Group
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33010
Country
United States
Facility Name
Accord Clinical Research, LLC
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Northwest Clinical Trials
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
ActivMed Practice and Research
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Affiliated Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Long Island Clinical Research
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Cary Medical Research
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
The UNC Center for Functional GI & Motility Disorders
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Medoff Medical/Vital re:Search
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27108
Country
United States
Facility Name
Unifour Medical Research
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Piedmont Medical Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Gastroenterology Research Consultant of Greater Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Oklahoma Foundation for Digestive Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Coastal Carolina Research Center in Goose Creek
City
Goose Creek
State/Province
South Carolina
ZIP/Postal Code
29455
Country
United States
Facility Name
ClinSearch
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Pioneer Research Solutions
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
Houston Medical Research Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Utah Clinical Trials, LLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
National Clinical Research Norfolk Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Aurora Health Center - Waukesha
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53186
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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