Trial Outcomes & Findings for Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome (NCT NCT00813098)

NCT ID: NCT00813098

Last Updated: 2010-12-02

Results Overview

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?"

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 155 participants
• Primary outcome timeframe: Week 4
• Results posted on: 2010-12-02

Participant Flow

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

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

Participant milestones

Measure	High Dose A high dose of LX1031; daily oral intake for 28 days	Low Dose A low dose of LX1031; daily oral intake for 28 days	Placebo Matching placebo dosing with daily oral intake
Overall Study STARTED	49	54	52
Overall Study COMPLETED	46	46	50
Overall Study NOT COMPLETED	3	8	2

Reasons for withdrawal

Measure	High Dose A high dose of LX1031; daily oral intake for 28 days	Low Dose A low dose of LX1031; daily oral intake for 28 days	Placebo Matching placebo dosing with daily oral intake
Overall Study Adverse Event	2	4	1
Overall Study Withdrawal by Subject	0	1	0
Overall Study Inability to complete study procedures	1	0	0
Overall Study Lost to Follow-up	0	1	0
Overall Study Protocol Violation	0	0	1
Overall Study Principal Investigator decision	0	1	0
Overall Study Withdrew Consent	0	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	High Dose n=43 Participants A high dose of LX1031; daily oral intake for 28 days	Low Dose n=44 Participants A low dose of LX1031; daily oral intake for 28 days	Placebo n=47 Participants Matching placebo dosing with daily oral intake	Total n=134 Participants Total of all reporting groups
Age Continuous	48.8 years STANDARD_DEVIATION 12.24 • n=5 Participants	46.7 years STANDARD_DEVIATION 13.34 • n=7 Participants	48.0 years STANDARD_DEVIATION 12.70 • n=5 Participants	47.8 years STANDARD_DEVIATION 12.70 • n=4 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	36 Participants n=7 Participants	7 Participants n=5 Participants	77 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	40 Participants n=5 Participants	57 Participants n=4 Participants
Race/Ethnicity, Customized White	37 participants n=5 Participants	40 participants n=7 Participants	44 participants n=5 Participants	121 participants n=4 Participants
Race/Ethnicity, Customized Black or African American	6 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	10 participants n=4 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants
Region of Enrollment United States	43 participants n=5 Participants	44 participants n=7 Participants	47 participants n=5 Participants	134 participants n=4 Participants
IB Sub-type IBS-M	9 participant n=5 Participants	9 participant n=7 Participants	12 participant n=5 Participants	30 participant n=4 Participants
IB Sub-type IBS-D	34 participant n=5 Participants	35 participant n=7 Participants	35 participant n=5 Participants	104 participant n=4 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Per protocol population; Last observation carried forward.

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?"

Outcome measures

Measure	High Dose n=43 Participants A high dose of LX1031; daily oral intake for 28 days	Low Dose n=44 Participants A low dose of LX1031; daily oral intake for 28 days	Placebo n=47 Participants Matching placebo dosing with daily oral intake
Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4	23 Participants	18 Participants	20 Participants

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: Per protocol population; Last observation carried forward.

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.

Outcome measures

Measure	High Dose n=43 Participants A high dose of LX1031; daily oral intake for 28 days	Low Dose n=44 Participants A low dose of LX1031; daily oral intake for 28 days	Placebo n=47 Participants Matching placebo dosing with daily oral intake
Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate	-0.32 Score on a scale Standard Deviation 0.367	-0.26 Score on a scale Standard Deviation 0.252	-0.33 Score on a scale Standard Deviation 0.369

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: Per protocol population; Last observation carried forward.

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.

Outcome measures

Measure	High Dose n=43 Participants A high dose of LX1031; daily oral intake for 28 days	Low Dose n=44 Participants A low dose of LX1031; daily oral intake for 28 days	Placebo n=47 Participants Matching placebo dosing with daily oral intake
Change From Baseline at Week 4 in Stool Consistency Scores	-1.11 Score on a scale Standard Deviation 0.920	-0.30 Score on a scale Standard Deviation 0.877	-0.56 Score on a scale Standard Deviation 1.187

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: Per protocol population; Last observation carried forward.

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.

Outcome measures

Measure	High Dose n=43 Participants A high dose of LX1031; daily oral intake for 28 days	Low Dose n=44 Participants A low dose of LX1031; daily oral intake for 28 days	Placebo n=47 Participants Matching placebo dosing with daily oral intake
Change From Baseline at Week 4 in Stool Frequency	-0.75 Number of daily stools Standard Deviation 1.021	-0.52 Number of daily stools Standard Deviation 0.921	-0.62 Number of daily stools Standard Deviation 0.970

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: Per protocol population; Last observation carried forward.

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.

Outcome measures

Measure	High Dose n=43 Participants A high dose of LX1031; daily oral intake for 28 days	Low Dose n=44 Participants A low dose of LX1031; daily oral intake for 28 days	Placebo n=47 Participants Matching placebo dosing with daily oral intake
Change From Baseline at Week 4 on the Severity of Bloating	-18.68 Score on a scale Standard Deviation 20.922	-15.13 Score on a scale Standard Deviation 15.469	-15.48 Score on a scale Standard Deviation 25.855

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: Per protocol population; Last observation carried forward.

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.

Outcome measures

Measure	High Dose n=43 Participants A high dose of LX1031; daily oral intake for 28 days	Low Dose n=44 Participants A low dose of LX1031; daily oral intake for 28 days	Placebo n=47 Participants Matching placebo dosing with daily oral intake
Change From Baseline at Week 4 on the Global Improvement Score.	1.56 Score on a scale Standard Deviation 1.501	1.33 Score on a scale Standard Deviation 1.459	1.47 Score on a scale Standard Deviation 1.666

Adverse Events

High Dose

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Low Dose

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	High Dose n=49 participants at risk A high dose of LX1031; daily oral intake for 28 days	Low Dose n=54 participants at risk A low dose of LX1031; daily oral intake for 28 days	Placebo n=52 participants at risk Matching placebo dosing with daily oral intake
Nervous system disorders Transient ischemic attack	2.0% 1/49 • Number of events 1 • 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.	0.00% 0/54 • 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.	0.00% 0/52 • 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

Measure	High Dose n=49 participants at risk A high dose of LX1031; daily oral intake for 28 days	Low Dose n=54 participants at risk A low dose of LX1031; daily oral intake for 28 days	Placebo n=52 participants at risk Matching placebo dosing with daily oral intake
Gastrointestinal disorders Abdominal Pain	6.1% 3/49 • Number of events 3 • 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.	0.00% 0/54 • 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.	9.6% 5/52 • Number of events 6 • 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.
Gastrointestinal disorders Nausea	8.2% 4/49 • Number of events 12 • 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.	9.3% 5/54 • Number of events 5 • 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.	7.7% 4/52 • Number of events 4 • 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.
Gastrointestinal disorders Diarrhea	10.2% 5/49 • Number of events 6 • 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.	1.9% 1/54 • Number of events 2 • 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.	3.8% 2/52 • Number of events 3 • 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.
Gastrointestinal disorders Abdominal Distension	0.00% 0/49 • 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.	3.7% 2/54 • Number of events 2 • 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.	5.8% 3/52 • Number of events 3 • 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.
Gastrointestinal disorders Dyspepsia	0.00% 0/49 • 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.	5.6% 3/54 • Number of events 3 • 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.	3.8% 2/52 • Number of events 3 • 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.
Nervous system disorders Headache	6.1% 3/49 • Number of events 4 • 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.	5.6% 3/54 • Number of events 3 • 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.	3.8% 2/52 • Number of events 2 • 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.

Additional Information

Clinical Project Manager

Lexicon Pharmaceuticals, Inc.

Phone: 281-863-3000

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor requires that written permission be given before the PI can release any data publicly.
• Publication restrictions are in place

Restriction type: OTHER