Trial Outcomes & Findings for Lubiprostone, Colonic Motility and Sensation (NCT NCT00953043)

NCT ID: NCT00953043

Last Updated: 2012-02-27

Results Overview

Colonic compliance is a measure of the "stiffness" of the colon, that is, what pressure was needed to reach half the maximum volume of the colon. After the barostat catheter was inserted in the colon, the catheter was connected to a barostat machine. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg up to 64 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: 1 hour after third dose of lubiprostone or placebo, on Day 3
• Results posted on: 2012-02-27

Participant Flow

The study was conducted between September 2007 and July 2008 at the Mayo Clinic, Rochester, Minnesota.

Participant milestones

Measure	Lubiprostone Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.	Placebo Subjects randomized to this arm received placebo medication for three days.
Overall Study STARTED	30	30
Overall Study COMPLETED	26	28
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Measure	Lubiprostone Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.	Placebo Subjects randomized to this arm received placebo medication for three days.
Overall Study Withdrawal by Subject	4	0
Overall Study Physician Decision	0	2

Baseline Characteristics

Lubiprostone, Colonic Motility and Sensation

Baseline characteristics by cohort

Measure	Lubiprostone n=30 Participants Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.	Placebo n=30 Participants Subjects randomized to this arm received placebo medication for three days.	Total n=60 Participants Total of all reporting groups
Age Continuous	35.1 years STANDARD_DEVIATION 2.31 • n=5 Participants	33.2 years STANDARD_DEVIATION 2.18 • n=7 Participants	34.1 years STANDARD_DEVIATION 1.58 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
Body Mass Index (BMI)	25.3 kg/m^2 STANDARD_DEVIATION 0.54 • n=5 Participants	25.5 kg/m^2 STANDARD_DEVIATION 0.74 • n=7 Participants	25.4 kg/m^2 STANDARD_DEVIATION 0.45 • n=5 Participants

PRIMARY outcome

Timeframe: 1 hour after third dose of lubiprostone or placebo, on Day 3

Colonic compliance is a measure of the "stiffness" of the colon, that is, what pressure was needed to reach half the maximum volume of the colon.

After the barostat catheter was inserted in the colon, the catheter was connected to a barostat machine. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg up to 64 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance.

Outcome measures

Measure	Lubiprostone n=26 Participants Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.	Placebo n=28 Participants Subjects randomized to this arm received placebo medication for three days.
Colonic Compliance	16.60 mm Hg Standard Error 0.817	16.50 mm Hg Standard Error 0.842

PRIMARY outcome

Timeframe: 30 minutes after the colonic tube placement, on Day 3

Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon).

Outcome measures

Measure	Lubiprostone n=26 Participants Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.	Placebo n=28 Participants Subjects randomized to this arm received placebo medication for three days.
Fasting Colonic Tone	101.9 mL Standard Error 7.479	112.8 mL Standard Error 6.068

PRIMARY outcome

Timeframe: 30 minutes after standard meal, on Day 3

Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon).

Outcome measures

Measure	Lubiprostone n=26 Participants Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.	Placebo n=28 Participants Subjects randomized to this arm received placebo medication for three days.
Postprandial Colonic Tone	78.69 mL Standard Error 6.202	75.01 mL Standard Error 3.492

PRIMARY outcome

Timeframe: approximately 1 hour after colonic tube placement, on Day 3

Pain was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.

Outcome measures

Measure	Lubiprostone n=26 Participants Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.	Placebo n=28 Participants Subjects randomized to this arm received placebo medication for three days.
Pain Sensation Ratings in Response to Colonic Distension at 32 mm HG Above Baseline Operating Pressure	55.2 mm Standard Error 4.38	55.8 mm Standard Error 4.16

SECONDARY outcome

Timeframe: approximately 1 hour after colonic tube placement, on Day 3

Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no gas sensation and 100 mm for extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of gas sensation.

Outcome measures

Measure	Lubiprostone n=26 Participants Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.	Placebo n=28 Participants Subjects randomized to this arm received placebo medication for three days.
Gas Sensation Ratings in Response to Colonic Distensions at 32 mm Hg Above Baseline Operating Pressure	51.4 mm Standard Error 4.37	54.6 mm Standard Error 4.48

SECONDARY outcome

Timeframe: approximately 45 min after colonic tube placement, on Day 3

The sensory threshold for first sensation was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.

Outcome measures

Measure	Lubiprostone n=26 Participants Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.	Placebo n=28 Participants Subjects randomized to this arm received placebo medication for three days.
Median Pressure When First Sensation Was Reported by 50% of Participants	16 mm Hg Interval 0.0 to 64.0	12 mm Hg Interval 0.0 to 64.0

SECONDARY outcome

Timeframe: approximately 45 min after colonic tube placement, on Day 3

The sensory threshold for first perception of gas was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first perception of gas. The investigator recorded the threshold pressure at which the participants reported this sensation.

Outcome measures

Measure	Lubiprostone n=26 Participants Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.	Placebo n=28 Participants Subjects randomized to this arm received placebo medication for three days.
Median Pressure When Gas Sensation Was First Reported by 50% of Participants	28 mm Hg Interval 0.0 to 64.0	24 mm Hg Interval 0.0 to 64.0

SECONDARY outcome

Timeframe: approximately 45 min after colonic tube placement, on Day 3

The sensory threshold for first perception of pain was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation.

Outcome measures

Measure	Lubiprostone n=26 Participants Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.	Placebo n=28 Participants Subjects randomized to this arm received placebo medication for three days.
Median Pressure When Pain Sensation Was First Reported by 50% of Participants	44 mm Hg Interval 0.0 to 64.0	40 mm Hg Interval 0.0 to 64.0

Adverse Events

Lubiprostone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lubiprostone n=26 participants at risk Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.	Placebo n=28 participants at risk Subjects randomized to this arm received placebo medication for three days.
Skin and subcutaneous tissue disorders Rash	0.00% 0/26 • 72 hours after completion of the study	3.6% 1/28 • Number of events 1 • 72 hours after completion of the study
Nervous system disorders Headache	3.8% 1/26 • Number of events 1 • 72 hours after completion of the study	0.00% 0/28 • 72 hours after completion of the study
Gastrointestinal disorders Diarrhea	3.8% 1/26 • Number of events 1 • 72 hours after completion of the study	0.00% 0/28 • 72 hours after completion of the study
Nervous system disorders Light-headed	0.00% 0/26 • 72 hours after completion of the study	3.6% 1/28 • Number of events 1 • 72 hours after completion of the study
Gastrointestinal disorders Nausea	0.00% 0/26 • 72 hours after completion of the study	3.6% 1/28 • Number of events 1 • 72 hours after completion of the study

Additional Information

Dr. Michael Camilleri, Professor of Medicine and Physiology, Gastroenterology

Mayo Clinic

Phone: 507-266-2305

Email: camilleri.michael@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place