Trial Outcomes & Findings for Effects of Lubiprostone on Gastrointestinal Transit & pH in Irritable Bowel Syndrome (IBS) With Constipation (NCT NCT01162863)
NCT ID: NCT01162863
Last Updated: 2017-01-27
Results Overview
Change in gastric emptying time, small bowel transit time, colon transit time and whole gut transit time measured in hours based on a measurement done at baseline and then again at 3 weeks into the intervention within each treatment arm
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
21-28 days
Results posted on
2017-01-27
Participant Flow
60 adults were screened of whom 4 were screen failures.Of the 56 remaining study participants, 2 were unable to swallow the wireless motility capsule and 2 more dropped out of the study prior to randomization yielding 52 randomized participants.
Participant milestones
| Measure |
Placebo
Placebo: taken orally for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
Lubiprostone 24 mcg QD
Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
Lubiprostone 8 mcg BID
Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: taken orally for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
Lubiprostone 24 mcg QD
Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
Lubiprostone 8 mcg BID
Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
Effects of Lubiprostone on Gastrointestinal Transit & pH in Irritable Bowel Syndrome (IBS) With Constipation
Baseline characteristics by cohort
| Measure |
Placebo
n=17 Participants
Placebo: taken orally for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
Lubiprostone 24 mcg QD
n=16 Participants
Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
Lubiprostone 8 mcg BID
n=17 Participants
Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
mean age
|
39.9 years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 18.7 • n=7 Participants
|
37.2 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
41.2 years
STANDARD_DEVIATION 17.2 • n=4 Participants
|
|
Gender
Female
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Gender
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
17 participants
n=5 Participants
|
50 participants
n=4 Participants
|
|
Baseline gastric emptying time
|
4.25 hours
STANDARD_DEVIATION 5.52 • n=5 Participants
|
3.18 hours
STANDARD_DEVIATION 0.95 • n=7 Participants
|
4.67 hours
STANDARD_DEVIATION 3.47 • n=5 Participants
|
4.01 hours
STANDARD_DEVIATION 3.74 • n=4 Participants
|
|
Baseline Small Bowel Transit time
|
4.84 hours
STANDARD_DEVIATION 1.69 • n=5 Participants
|
4.01 hours
STANDARD_DEVIATION 1.02 • n=7 Participants
|
4.81 hours
STANDARD_DEVIATION 2.13 • n=5 Participants
|
4.63 hours
STANDARD_DEVIATION 1.75 • n=4 Participants
|
|
Baseline Colon Transit Time
|
32.18 hours
STANDARD_DEVIATION 16.46 • n=5 Participants
|
44.61 hours
STANDARD_DEVIATION 27.18 • n=7 Participants
|
37.12 hours
STANDARD_DEVIATION 30.04 • n=5 Participants
|
38.15 hours
STANDARD_DEVIATION 25.31 • n=4 Participants
|
|
Baseline Whole Gut Transit Time
|
41.47 hours
STANDARD_DEVIATION 16.26 • n=5 Participants
|
51.81 hours
STANDARD_DEVIATION 26.78 • n=7 Participants
|
47.0 hours
STANDARD_DEVIATION 30.0 • n=5 Participants
|
47.0 hours
STANDARD_DEVIATION 24.97 • n=4 Participants
|
|
Baseline Small Bowel pH
|
6.82 units on pH scale
STANDARD_DEVIATION 0.28 • n=5 Participants
|
6.75 units on pH scale
STANDARD_DEVIATION 0.34 • n=7 Participants
|
6.77 units on pH scale
STANDARD_DEVIATION 0.39 • n=5 Participants
|
6.78 units on pH scale
STANDARD_DEVIATION 0.33 • n=4 Participants
|
|
Baseline Colon pH
|
6.56 units on pH scale
STANDARD_DEVIATION 0.55 • n=5 Participants
|
6.75 units on pH scale
STANDARD_DEVIATION 0.34 • n=7 Participants
|
6.47 units on pH scale
STANDARD_DEVIATION 0.48 • n=5 Participants
|
6.50 units on pH scale
STANDARD_DEVIATION 0.51 • n=4 Participants
|
|
Baseline Small Bowel Motility Index
|
13.14 units on a scale
STANDARD_DEVIATION 1.66 • n=5 Participants
|
12.80 units on a scale
STANDARD_DEVIATION 1.86 • n=7 Participants
|
12.65 units on a scale
STANDARD_DEVIATION 2.26 • n=5 Participants
|
12.86 units on a scale
STANDARD_DEVIATION 1.93 • n=4 Participants
|
|
Baseline Colon Motility Index
|
16.26 units on a scale
STANDARD_DEVIATION 1.57 • n=5 Participants
|
16.9 units on a scale
STANDARD_DEVIATION 2.14 • n=7 Participants
|
16.17 units on a scale
STANDARD_DEVIATION 1.79 • n=5 Participants
|
16.43 units on a scale
STANDARD_DEVIATION 1.83 • n=4 Participants
|
PRIMARY outcome
Timeframe: 21-28 daysChange in gastric emptying time, small bowel transit time, colon transit time and whole gut transit time measured in hours based on a measurement done at baseline and then again at 3 weeks into the intervention within each treatment arm
Outcome measures
| Measure |
Placebo
n=17 Participants
Placebo: taken orally for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
Lubiprostone 24 mcg QD
n=16 Participants
Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
Lubiprostone 8 mcg BID
n=17 Participants
Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
|---|---|---|---|
|
Change in Gastric Emptying Time, Small Bowel Transit Time, Colon Transit Time and Whole Gut Transit Time From Baseline
Gastric emptying time
|
5.49 hours
Standard Deviation 13.77
|
6.52 hours
Standard Deviation 15.33
|
-0.16 hours
Standard Deviation 3.17
|
|
Change in Gastric Emptying Time, Small Bowel Transit Time, Colon Transit Time and Whole Gut Transit Time From Baseline
Small bowel transit time
|
0.2 hours
Standard Deviation 2.04
|
0.15 hours
Standard Deviation 1.78
|
-0.001 hours
Standard Deviation 2.68
|
|
Change in Gastric Emptying Time, Small Bowel Transit Time, Colon Transit Time and Whole Gut Transit Time From Baseline
Colon transit time
|
5.75 hours
Standard Deviation 21.23
|
-4.43 hours
Standard Deviation 44.6
|
2.59 hours
Standard Deviation 31.15
|
|
Change in Gastric Emptying Time, Small Bowel Transit Time, Colon Transit Time and Whole Gut Transit Time From Baseline
Whole gut transit time
|
10.32 hours
Standard Deviation 27.3
|
-1.74 hours
Standard Deviation 42.67
|
1.67 hours
Standard Deviation 29.73
|
SECONDARY outcome
Timeframe: 21-28 daysChange in the mean pH of the small intestine and colon based on a measurement done at baseline and then again at 3 weeks into the intervention.
Outcome measures
| Measure |
Placebo
n=17 Participants
Placebo: taken orally for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
Lubiprostone 24 mcg QD
n=16 Participants
Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
Lubiprostone 8 mcg BID
n=17 Participants
Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
|---|---|---|---|
|
Change in Small Bowel pH and Colon pH From Baseline
Small bowel pH
|
0.18 pH
Standard Deviation 0.37
|
0.23 pH
Standard Deviation 0.36
|
0.24 pH
Standard Deviation 0.4
|
|
Change in Small Bowel pH and Colon pH From Baseline
Colon pH
|
-0.03 pH
Standard Deviation 0.50
|
-0.07 pH
Standard Deviation 0.45
|
0.27 pH
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: 21-28 daysChange in the motility index defined as the natural log \[(sum of pressure amplitudes times the number of contractions) + 1\] for the small bowel and colon based on a measurement done at baseline and then again at 3 weeks into the intervention.
Outcome measures
| Measure |
Placebo
n=17 Participants
Placebo: taken orally for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
Lubiprostone 24 mcg QD
n=16 Participants
Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
Lubiprostone 8 mcg BID
n=17 Participants
Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
|---|---|---|---|
|
Change in Motility Pattern of the Small Bowel and Colon From Baseline as Defined by the Motility Index
Small bowel motility index
|
0.06 units on a scale
Standard Deviation 1.37
|
-0.01 units on a scale
Standard Deviation 1.89
|
0.6 units on a scale
Standard Deviation 2.36
|
|
Change in Motility Pattern of the Small Bowel and Colon From Baseline as Defined by the Motility Index
Colon motility index
|
-0.34 units on a scale
Standard Deviation 1.96
|
-1.32 units on a scale
Standard Deviation 1.97
|
0.17 units on a scale
Standard Deviation 1.72
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Lubiprostone 24 mcg QD
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Lubiprostone 8 mcg BID
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=18 participants at risk
Placebo: taken orally for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
Lubiprostone 24 mcg QD
n=17 participants at risk
Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
Lubiprostone 8 mcg BID
n=17 participants at risk
Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
|---|---|---|---|
|
Cardiac disorders
Dehydration
|
5.6%
1/18
|
0.00%
0/17
|
0.00%
0/17
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
1/18
|
0.00%
0/17
|
0.00%
0/17
|
Other adverse events
| Measure |
Placebo
n=18 participants at risk
Placebo: taken orally for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
Lubiprostone 24 mcg QD
n=17 participants at risk
Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
Lubiprostone 8 mcg BID
n=17 participants at risk
Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days
Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
2/18
|
35.3%
6/17
|
25.0%
4/16
|
|
Gastrointestinal disorders
Nausea
|
22.2%
4/18
|
35.3%
6/17
|
35.3%
6/17
|
|
General disorders
Headache
|
5.6%
1/18
|
11.8%
2/17
|
11.8%
2/17
|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort
|
0.00%
0/18
|
0.00%
0/17
|
5.9%
1/17
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18
|
5.9%
1/17
|
5.9%
1/17
|
|
Gastrointestinal disorders
Flatulence
|
22.2%
4/18
|
11.8%
2/17
|
23.5%
4/17
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
2/18
|
23.5%
4/17
|
11.8%
2/17
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/18
|
11.8%
2/17
|
23.5%
4/17
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18
|
17.6%
3/17
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection
|
5.6%
1/18
|
0.00%
0/17
|
5.9%
1/17
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place