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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00813098

Enrollment

155

Registered

2008-12-22

Start date

2008-12-31

Completion date

2010-08-31

Last updated

2010-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

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.

Interventions

DRUGLX1031 High Dose

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

DRUGLX1031 Low Dose

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

DRUGPlacebo

Matching placebo dosing with daily oral intake

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4	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

Measure	Time frame	Description
Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate	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	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	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	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.	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.

Countries

United States

Participant flow

Recruitment details

This was a multi-center trial in the United States, with 36 investigators participating.

Pre-assignment details

There was a 14-day Run-in period before randomization.

Participants by arm

Arm	Count
High Dose A high dose of LX1031; daily oral intake for 28 days	43
Low Dose A low dose of LX1031; daily oral intake for 28 days	44
Placebo Matching placebo dosing with daily oral intake	47
Total	134

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	2	4	1
Overall Study	Inability to complete study procedures	1	0	0
Overall Study	Lost to Follow-up	0	1	0
Overall Study	Principal Investigator decision	0	1	0
Overall Study	Protocol Violation	0	0	1
Overall Study	Withdrawal by Subject	0	1	0
Overall Study	Withdrew Consent	0	1	0

Baseline characteristics

Characteristic	High Dose	Low Dose	Placebo	Total
Age Continuous	48.8 years STANDARD_DEVIATION 12.24	46.7 years STANDARD_DEVIATION 13.34	48.0 years STANDARD_DEVIATION 12.7	47.8 years STANDARD_DEVIATION 12.7
IB Sub-type IBS-D	34 participant	35 participant	35 participant	104 participant
IB Sub-type IBS-M	9 participant	9 participant	12 participant	30 participant
Race/Ethnicity, Customized Asian	0 participants	0 participants	1 participants	1 participants
Race/Ethnicity, Customized Black or African American	6 participants	3 participants	1 participants	10 participants
Race/Ethnicity, Customized Other	0 participants	1 participants	1 participants	2 participants
Race/Ethnicity, Customized White	37 participants	40 participants	44 participants	121 participants
Region of Enrollment United States	43 participants	44 participants	47 participants	134 participants
Sex: Female, Male Female	34 Participants	36 Participants	7 Participants	77 Participants
Sex: Female, Male Male	9 Participants	8 Participants	40 Participants	57 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	11 / 49	11 / 54	13 / 52
serious Total, serious adverse events	1 / 49	0 / 54	0 / 52

Outcome results

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?

Time frame: Week 4